Rosacea
Conditions
Keywords
rosacea, tretinoin, atralin
Brief summary
Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).
Interventions
DRUGvehicle gel
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
DRUGAtralin gel
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Sponsors
Bausch Health Americas, Inc.
Lisa E. Maier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects 18 years of age and older of any race. 2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation. 3. Willing and able to understand and sign informed consent. 4. Able to complete study and comply with study procedures.
Exclusion criteria
1. Severe self reported facial sensitivity 2. History of allergy to fish 3. Severe sun sensitivity 4. Severe erythematotelangiectatic rosacea requiring systemic treatment 5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale 6. Unwilling to undergo facial biopsies 7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids 8. Use of topical rosacea treatments in the past 2 weeks. 9. Use of systemic antibiotics in the past 4 weeks. 10. Use of systemic retinoids within the past 6 months. 11. Use of topical retinoids within the past 3 months 12. Use of laser or light based rosacea treatments within the past 2 months. 13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months 14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid 15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments. 16. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study. 17. If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study). 18. Subjects who are lactating. 19. Use of any investigational therapy within the past 4 weeks. 20. Known hypersensitivity or previous allergic reaction to retinoids 21. Carcinoid, Pheochromocytoma or other systemic flushing causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | 24 weeks | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin |
| Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | 24 weeks | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin |
| Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | 24 weeks | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin |
| Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | 24 weeks | Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | 24 weeks | Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?. |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | 24 weeks | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea. |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | 24 weeks | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea. |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | 24 weeks | Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Erythematotelangiectatic Signs: Telangiectasia | 2, 6, 12, 18 weeks | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. |
| Severity of Erythematotelangiectatic Signs: Facial Edema | 2, 6, 12, 18 weeks | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. |
| Severity of Erythematotelangiectatic Signs: Dryness/Irritation | 2, 6, 12, 18 weeks | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | 2, 6, 12, 18 weeks | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | 2, 6, 12, 18 weeks | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance |
| Quality of Life | 2, 6, 12, 18, 24 weeks | The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | 2, 6, 12, 18 weeks | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance |
| Skin Irritation Assessed by Facial Stinging Upon Product Application | 2, 6, 12, 18 weeks | — |
| Skin Irritation Assessed by Facial Itching Upon Product Application | 2, 6, 12, 18 weeks | — |
| Skin Irritation Assessed by Facial Burning Upon Product Application | 2, 6, 12, 18 weeks | — |
| Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | 2, 6, 12, 18 weeks | Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance |
| Photodamage | 24 weeks | Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used. |
| Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | 2, 6, 12, 18 and 24 weeks | Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea |
| Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | 2, 6, 12, 18 and 24 weeks | Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea |
| Signs of Other Rosacea Subtypes: Papulopustular | 2, 6, 12, 18, 24 weeks | Signs of other rosacea subtypes includes papulopustular, inflammatory papule count |
| Molecular Markers of Inflammation | 24 weeks | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa). |
| Molecular Evidence of Photodamage | 24 weeks | These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9). |
| Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | 2, 6, 12, 18 weeks | Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Gel Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. | 22 |
| Atralin Gel Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. | 46 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 6 |
Baseline characteristics
| Characteristic | Vehicle Gel | Atralin Gel | Total |
|---|---|---|---|
| Age, Continuous | 55.00 years STANDARD_DEVIATION 11.24 | 56.09 years STANDARD_DEVIATION 11.58 | 55.74 years STANDARD_DEVIATION 11.39 |
| Race/Ethnicity, Customized Caucasian, European descent | 22 participants | 43 participants | 65 participants |
| Race/Ethnicity, Customized Caucasian, non-European descent | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Middle Eastern | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 22 participants | 46 participants | 68 participants |
| Sex: Female, Male Female | 15 Participants | 39 Participants | 54 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 22 | 25 / 46 |
| serious Total, serious adverse events | 0 / 22 | 1 / 46 |
Outcome results
Primary
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Severe Scaling/Fissuring | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Slight Flaking | 7 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Moderate Flaking/Scaling | 1 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Marked Scaling/Fissuring | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | None | 13 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Marked Scaling/Fissuring | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | None | 16 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Severe Scaling/Fissuring | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Moderate Flaking/Scaling | 8 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin | Slight Flaking | 12 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.p-value: 0.13Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Severe | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Mild | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Moderate | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | None | 21 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | None | 31 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema | Mild | 5 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.p-value: 0.15Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time frame: 24 weeks
Population: Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Marked Erythema | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | None | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Moderate Erythema | 9 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Deep Erythema | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Mild Erythema | 12 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Deep Erythema | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Mild Erythema | 22 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Moderate Erythema | 13 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | Marked Erythema | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) | None | 0 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.p-value: 0.93Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Mild | 10 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Severe | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Moderate | 10 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | None | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Moderate | 13 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | None | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Severe | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia | Mild | 22 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.p-value: 0.79Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Like product | 7 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Dislike product | 3 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Strongly like product | 2 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Strongly dislike product | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Neutral | 9 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Strongly dislike product | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Like product | 7 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Neutral | 16 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Dislike product | 5 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product | Strongly like product | 8 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.p-value: 0.77Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 6 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 15 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 7 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 28 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.p-value: 0.75Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 4 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 17 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 8 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 27 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.p-value: 0.68Wilcoxon (Mann-Whitney)
Primary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?.
Time frame: 24 weeks
Population: LOCF, Complete Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 19 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 2 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 33 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 3 participants |
Comparison: Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 1Fisher Exact
Secondary
Molecular Evidence of Photodamage
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).
Time frame: 24 weeks
Population: ITT Population that completed baseline and week 24 biopsies
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Gel | Molecular Evidence of Photodamage | COL-1 Fold Change Score | 1.50 fold change | Standard Deviation 1.09 |
| Vehicle Gel | Molecular Evidence of Photodamage | MMP3 Fold Change Score | 2.87 fold change | Standard Deviation 3.58 |
| Vehicle Gel | Molecular Evidence of Photodamage | MMP9 Fold Change Score | 2.53 fold change | Standard Deviation 4.16 |
| Vehicle Gel | Molecular Evidence of Photodamage | COL-3 Fold Change Score | 1.39 fold change | Standard Deviation 0.77 |
| Vehicle Gel | Molecular Evidence of Photodamage | MMP1 Fold Change Score | 1.44 fold change | Standard Deviation 1.28 |
| Atralin Gel | Molecular Evidence of Photodamage | COL-3 Fold Change Score | 1.04 fold change | Standard Deviation 0.63 |
| Atralin Gel | Molecular Evidence of Photodamage | COL-1 Fold Change Score | 1.17 fold change | Standard Deviation 0.65 |
| Atralin Gel | Molecular Evidence of Photodamage | MMP1 Fold Change Score | 0.83 fold change | Standard Deviation 0.6 |
| Atralin Gel | Molecular Evidence of Photodamage | MMP9 Fold Change Score | 1.67 fold change | Standard Deviation 1.6 |
| Atralin Gel | Molecular Evidence of Photodamage | MMP3 Fold Change Score | 0.69 fold change | Standard Deviation 0.64 |
Comparison: Group comparisons of COL-1 at Week 24 visit were made using fold change data.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of COL-3 at Week 24 visit were made using fold change data.p-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of MMP-1 at Week 24 visit were made using fold change data.p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of MMP-3 at Week 24 visit were made using fold change data.p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of MMP-9 at Week 24 visit were made using fold change data.p-value: 0.61Wilcoxon (Mann-Whitney)
Secondary
Molecular Markers of Inflammation
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).
Time frame: 24 weeks
Population: ITT Population that completed baseline and Week 24 biopsies
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Gel | Molecular Markers of Inflammation | TAC1 Fold Change Score | 2.91 fold change | Standard Deviation 1.94 |
| Vehicle Gel | Molecular Markers of Inflammation | CXCL12 Fold Change Score | 1.10 fold change | Standard Deviation 0.8 |
| Vehicle Gel | Molecular Markers of Inflammation | CXCR4 Fold Change Score | 1.39 fold change | Standard Deviation 1.18 |
| Vehicle Gel | Molecular Markers of Inflammation | TNFa Fold Change Score | 1.24 fold change | Standard Deviation 0.84 |
| Atralin Gel | Molecular Markers of Inflammation | CXCR4 Fold Change Score | 1.88 fold change | Standard Deviation 1.81 |
| Atralin Gel | Molecular Markers of Inflammation | TAC1 Fold Change Score | 0.87 fold change | Standard Deviation 0.9 |
| Atralin Gel | Molecular Markers of Inflammation | TNFa Fold Change Score | 1.17 fold change | Standard Deviation 0.97 |
| Atralin Gel | Molecular Markers of Inflammation | CXCL12 Fold Change Score | 1.20 fold change | Standard Deviation 0.59 |
Comparison: Group comparisons of TAC1 at Week 24 visit were made using fold change data.p-value: 0.003Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of CXCR4 at Week 24 visit were made using fold change data.p-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of CXCL12 at Week 24 visit were made using fold change data.p-value: 0.68Wilcoxon (Mann-Whitney)
Comparison: Group comparisons of TNFa at Week 24 visit were made using fold change data.p-value: 0.76Wilcoxon (Mann-Whitney)
Secondary
Photodamage
Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.
Time frame: 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Photodamage | Score of 2, Mild Photo Damage | 5 participants |
| Vehicle Gel | Photodamage | Score of 7, Severe Photo Damage, < score of 8 | 0 participants |
| Vehicle Gel | Photodamage | Score of 5, Moderate Photo Damage, > score of 4 | 2 participants |
| Vehicle Gel | Photodamage | Score of 8, Severe Photo Damage | 0 participants |
| Vehicle Gel | Photodamage | Score of 3, Mild Photo Damage, > score of 2 | 4 participants |
| Vehicle Gel | Photodamage | Score of 6, Moderate/Severe Photo Damage | 2 participants |
| Vehicle Gel | Photodamage | Score of 1, Mild Photo Damage, < score of 2 | 3 participants |
| Vehicle Gel | Photodamage | Score of 4, Moderate Photo Damage | 5 participants |
| Vehicle Gel | Photodamage | Score of 0, No Photo Damage | 0 participants |
| Atralin Gel | Photodamage | Score of 4, Moderate Photo Damage | 9 participants |
| Atralin Gel | Photodamage | Score of 1, Mild Photo Damage, < score of 2 | 1 participants |
| Atralin Gel | Photodamage | Score of 2, Mild Photo Damage | 11 participants |
| Atralin Gel | Photodamage | Score of 3, Mild Photo Damage, > score of 2 | 12 participants |
| Atralin Gel | Photodamage | Score of 5, Moderate Photo Damage, > score of 4 | 2 participants |
| Atralin Gel | Photodamage | Score of 6, Moderate/Severe Photo Damage | 1 participants |
| Atralin Gel | Photodamage | Score of 7, Severe Photo Damage, < score of 8 | 0 participants |
| Atralin Gel | Photodamage | Score of 8, Severe Photo Damage | 0 participants |
| Atralin Gel | Photodamage | Score of 0, No Photo Damage | 0 participants |
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
Quality of Life
The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: 2, 6, 12, 18, 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel | Quality of Life | 2.62 units on a scale | Standard Deviation 3.01 |
| Atralin Gel | Quality of Life | 2.28 units on a scale | Standard Deviation 2.31 |
| Vehicle Gel at Week 6 | Quality of Life | 2.19 units on a scale | Standard Deviation 2.36 |
| Atralin Gel at Week 6 | Quality of Life | 2.44 units on a scale | Standard Deviation 2.21 |
| Vehicle Gel at Week 12 | Quality of Life | 1.95 units on a scale | Standard Deviation 2.25 |
| Atralin Gel at Week 12 | Quality of Life | 2.03 units on a scale | Standard Deviation 1.92 |
| Vehicle Gel at Week 18 | Quality of Life | 1.52 units on a scale | Standard Deviation 1.63 |
| Atralin Gel at Week 18 | Quality of Life | 2.14 units on a scale | Standard Deviation 2.26 |
| Vehicle Gel at Week 24 | Quality of Life | 1.43 units on a scale | Standard Deviation 1.6 |
| Atralin Gel at Week 24 | Quality of Life | 2.14 units on a scale | Standard Deviation 2.43 |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.94Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.57Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.24Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 16 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 3 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 2 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 7 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 26 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 2 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 17 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 3 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 24 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 10 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 1 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 5 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 16 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 5 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 8 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 23 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 16 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 5 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Mild | 10 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Moderate | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | Severe | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning | None | 24 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.p-value: 0.8Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.p-value: 0.31Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.p-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.p-value: 0.46Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 17 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 4 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 10 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 25 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 19 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 2 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 24 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 10 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 2 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 2 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 19 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 1 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 9 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 26 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 19 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Mild | 8 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Moderate | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | Severe | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging | None | 26 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.p-value: 0.05Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.p-value: 0.14Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 17 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 4 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 34 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 2 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 18 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 3 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 32 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 4 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 18 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 3 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 32 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 4 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 3 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 18 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | Yes | 34 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing | No | 2 participants |
Comparison: Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.p-value: 0.18Fisher Exact
Comparison: Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.p-value: 0.7Fisher Exact
Comparison: Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.p-value: 0.7Fisher Exact
Comparison: Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.p-value: 0.35Fisher Exact
Secondary
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 17 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 3 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 8 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 23 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 3 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 4 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 2 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 13 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 20 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 3 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 9 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 4 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 12 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 2 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 4 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 1 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 18 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 11 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 5 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 13 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 1 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 5 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly dislike product | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Dislike product | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Strongly like product | 7 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Neutral | 18 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment | Like product | 9 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.p-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.p-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.p-value: 0.17Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 8 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 1 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 12 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 17 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 5 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 13 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 7 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 13 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 3 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 13 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 19 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 1 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 1 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 12 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 8 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 7 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 18 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 10 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 1 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 2 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 13 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 6 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Severe Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Marked Scaling/Fissuring | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | None | 14 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Moderate Flaking/Scaling | 8 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Dryness/Irritation | Slight Flaking | 14 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.p-value: 0.54Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.p-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.p-value: 0.09Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Signs: Facial Edema
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 21 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 33 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 2 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 21 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 3 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 33 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 21 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 5 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 31 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 21 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | None | 32 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Moderate | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Mild | 4 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Facial Edema | Severe | 0 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.p-value: 0.29Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.p-value: 0.29Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.p-value: 0.29Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 10 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 11 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 18 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 17 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 1 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 9 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 1 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 11 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 18 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 16 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 12 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 1 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 8 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 20 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 2 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 14 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 11 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 9 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 1 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Mild Erythema | 23 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Marked Erythema | 2 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Moderate Erythema | 11 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | None | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) | Deep Erythema | 0 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.p-value: 0.44Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
Severity of Erythematotelangiectatic Signs: Telangiectasia
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 7 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 14 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 0 participants |
| Vehicle Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 1 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 17 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 0 participants |
| Atralin Gel | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 18 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 9 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 0 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 1 participants |
| Vehicle Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 11 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 1 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 0 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 19 participants |
| Atralin Gel at Week 6 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 16 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 0 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 10 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 10 participants |
| Vehicle Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 1 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 20 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 0 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 15 participants |
| Atralin Gel at Week 12 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 1 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 1 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 0 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 10 participants |
| Vehicle Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 10 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Mild | 21 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Moderate | 14 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | None | 0 participants |
| Atralin Gel at Week 18 | Severity of Erythematotelangiectatic Signs: Telangiectasia | Severe | 1 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.p-value: 0.96Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.p-value: 0.91Wilcoxon (Mann-Whitney)
Secondary
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
Time frame: 2, 6, 12, 18 and 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 18 participants |
| Vehicle Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Vehicle Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 3 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 4 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 32 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 2 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 19 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 31 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 1 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 4 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 3 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 18 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 32 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 4 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 19 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 2 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 4 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 32 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 1 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 19 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 1 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Severe | 0 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | Mild | 2 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea | None | 34 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosaceap-value: 0.62Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosaceap-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosaceap-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosaceap-value: 0.45Wilcoxon (Mann-Whitney)
Secondary
Signs of Other Rosacea Subtypes: Papulopustular
Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
Time frame: 2, 6, 12, 18, 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Gel | Signs of Other Rosacea Subtypes: Papulopustular | 0.19 inflammatory papule | Standard Deviation 0.51 |
| Atralin Gel | Signs of Other Rosacea Subtypes: Papulopustular | 0.25 inflammatory papule | Standard Deviation 0.73 |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Papulopustular | 0.14 inflammatory papule | Standard Deviation 0.48 |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Papulopustular | 0.28 inflammatory papule | Standard Deviation 0.66 |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Papulopustular | 0.43 inflammatory papule | Standard Deviation 0.87 |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Papulopustular | 0.50 inflammatory papule | Standard Deviation 1.59 |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Papulopustular | 0.48 inflammatory papule | Standard Deviation 0.87 |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Papulopustular | 0.64 inflammatory papule | Standard Deviation 1.59 |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Papulopustular | 0.38 inflammatory papule | Standard Deviation 0.67 |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Papulopustular | 1.03 inflammatory papule | Standard Deviation 2.69 |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.92Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
Time frame: 2, 6, 12, 18 and 24 weeks
Population: LOCF, Complete-Case ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 21 participants |
| Vehicle Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Vehicle Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 0 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 2 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Atralin Gel | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 34 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 21 participants |
| Vehicle Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 0 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 34 participants |
| Atralin Gel at Week 6 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 2 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 21 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 0 participants |
| Vehicle Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 2 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 34 participants |
| Atralin Gel at Week 12 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 21 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 0 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 2 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 34 participants |
| Atralin Gel at Week 18 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 0 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 21 participants |
| Vehicle Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | None | 35 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Moderate | 0 participants |
| Atralin Gel at Week 24 | Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea | Mild | 1 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Skin Irritation Assessed by Facial Burning Upon Product Application
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 17 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 0 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 3 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 1 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 7 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 28 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 0 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 19 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 2 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 26 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 10 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 0 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 1 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 20 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 0 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 10 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 24 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 2 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 2 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 19 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 0 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | No burning | 29 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | A little burning | 6 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Burning Upon Product Application | A lot of burning | 1 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.p-value: 0.67Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.p-value: 0.42Wilcoxon (Mann-Whitney)
Secondary
Skin Irritation Assessed by Facial Itching Upon Product Application
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 18 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 0 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 2 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 0 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 5 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 31 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 0 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 21 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 0 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 27 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 7 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 2 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 0 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 21 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 0 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 5 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 30 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 1 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 0 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 21 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 0 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | No itching | 31 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | A little itching | 4 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Itching Upon Product Application | A lot of itching | 1 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.p-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.p-value: 0.15Wilcoxon (Mann-Whitney)
Secondary
Skin Irritation Assessed by Facial Stinging Upon Product Application
Time frame: 2, 6, 12, 18 weeks
Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 17 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
| Vehicle Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 3 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 12 participants |
| Atralin Gel | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 24 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 20 participants |
| Vehicle Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 1 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 20 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 15 participants |
| Atralin Gel at Week 6 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 1 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 1 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 20 participants |
| Vehicle Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 9 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 25 participants |
| Atralin Gel at Week 12 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 2 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 2 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 19 participants |
| Vehicle Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | No stinging | 25 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A little stinging | 11 participants |
| Atralin Gel at Week 18 | Skin Irritation Assessed by Facial Stinging Upon Product Application | A lot of stinging | 0 participants |
Comparison: Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.p-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.p-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.p-value: 0.1Wilcoxon (Mann-Whitney)