Skin Care
Conditions
Keywords
Glycerol, Niacinamide, Skin Care
Brief summary
This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days.
Detailed description
This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group, single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in healthy females with clinically-evaluated sensitive skin as determined by a positive response to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no ophthalmological conditions. Assessments will be performed and recorded for 21 days.
Interventions
OTHERSerum
Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.
OTHERLotion
Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.
OTHERCream
Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Evaluator-blind
Intervention model description
The study is a randomized, 3-arm parallel group study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures. * A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee , no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the participant's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * Participants with sensitive facial skin, defined as a positive response to a LAST in the nasolabial area. * A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for erythema per dermatological evaluation. * A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for dryness per dermatological evaluation. * A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling per dermatological evaluation. * A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema per dermatological evaluation. * A participant with an ophthalmologist total signs and symptoms of ocular irritation score of zero (0) per dermatological evaluation.
Exclusion criteria
* A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family. * A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. * A participant who is pregnant (self-reported) or intends to become pregnant during the study duration. * A participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * A participant unwilling or unable to comply with the protocol lifestyle considerations required by this study, as described in this protocol. * A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema. * A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients. * A participant with any history of significant diseases or medical conditions known to alter skin or eye appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. * A participant presenting open sores, pimples, or cysts at the application site (face). * A participant considered immune-compromised. * A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and/or corticosteroids. * A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit. * A participant who has been vaccinated up to 1 month before the screening visit or who is intending to receive a vaccination during their participation in the study. * A participant with a recent history (within the last 5 years) of alcohol or other substance abuse. * A participant with any skin marks on the face that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). * A participant who has previously been enrolled in this study. * A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperaemia or other active ocular diseases. * A participant currently using any medication which in the opinion of the investigator (medically qualified designee) may affect the evaluation of the investigational product or place the participant at undue risk. * A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study. * A participant with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) for edema, scaling, erythema, or dryness per dermatological evaluation. * A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use | Day 21 | The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use | Day 21 | The clinically relevant positive outcome for ocular irritation was defined as the number of participants who experienced an increase in total ocular irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The ophthalmologist assessment of signs and symptoms of ocular irritation total score was calculated as the sum of the individual ocular response attributes (eczema of the eyelid, conjunctivitis, follicles, and chemosis conjunctivae). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated the most severe condition. |
| Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Baseline and 1 to 2 hours post first use | Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total cutaneous score at 1 to 2 hours minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score. |
| Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Baseline and Day 21 | Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total cutaneous score at Day 21 minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score. |
| Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Baseline and 1 to 2 hours post first use | Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total ocular score at 1 to 2 hours minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score. |
| Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Baseline and Day 21 | Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total ocular score at Day 21 minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted at single center in Germany.
Pre-assignment details
A total of 286 participants were screened of which 150 participants were enrolled and allocated to a randomized treatment. A total of 147 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Developmental Serum The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit. | 50 |
| Developmental Lotion The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit. | 49 |
| Developmental Cream The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit. | 51 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Covid-19-related | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Developmental Serum | Developmental Lotion | Developmental Cream | Total |
|---|---|---|---|---|
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 11.06 | 47.8 Years STANDARD_DEVIATION 11.3 | 44.6 Years STANDARD_DEVIATION 13.72 | 47.0 Years STANDARD_DEVIATION 12.15 |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 46 Participants | 48 Participants | 50 Participants | 144 Participants |
| Sex: Female, Male Female | 50 Participants | 49 Participants | 51 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 5 / 50 | 6 / 49 | 4 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 | 0 / 51 |
Outcome results
Primary
Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use
The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation.
Time frame: Day 21
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Developmental Serum | Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use | 1 Participants |
| Developmental Lotion | Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use | 0 Participants |
| Developmental Cream | Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use | 0 Participants |
Secondary
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application
Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total cutaneous score at 1 to 2 hours minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.
Time frame: Baseline and 1 to 2 hours post first use
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 5 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -6 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 5 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -14 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 3 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3.5 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 2 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -9 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -10 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 6 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 3 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -10 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -9 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -14 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -6 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4.5 | 7 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 6 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 2 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 2 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 3 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -6 | 3 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -9 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 7 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -7.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -10 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 4 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 3 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 7 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 2 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -4 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -8.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3.5 | 6 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -14 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -5.5 | 2 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 3 Participants |
Secondary
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use
Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total cutaneous score at Day 21 minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.
Time frame: Baseline and Day 21
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10.5 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -9 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6.5 | 3 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5.5 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2.5 | 6 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 2 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -7.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1.5 | 6 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -0.5 | 3 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0.5 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2 | 4 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 1 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -14 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1 | 7 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 2 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6 | 2 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2.5 | 4 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -0.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -14 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -9 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -7.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4 | 2 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1.5 | 4 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 1 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 2 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3.5 | 3 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 0 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -3 | 6 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2.5 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -0.5 | 3 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -2 | 4 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1.5 | 10 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8 | 2 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -10 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -7.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -4 | 2 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -8.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -6 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -9 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= 1 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -5.5 | 2 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -14 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | Total score= -1 | 1 Participants |
Secondary
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use
Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total ocular score at Day 21 minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.
Time frame: Baseline and Day 21
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 2.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0 | 28 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -3 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1.5 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 6 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1 | 2 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 4.5 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 3 | 0 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1.5 | 1 Participants |
| Developmental Serum | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -0.5 | 9 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2.5 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0 | 21 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0.5 | 5 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1 | 4 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 3 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 4.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -3 | 1 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2 | 2 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1.5 | 3 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1 | 2 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -0.5 | 7 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 2.5 | 0 Participants |
| Developmental Lotion | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 6 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0.5 | 4 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1 | 2 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 3 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 1.5 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -0.5 | 7 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 6 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 2.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1 | 5 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -2 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -1.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 4.5 | 1 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= -3 | 0 Participants |
| Developmental Cream | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | Total score= 0 | 28 Participants |
Secondary
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application
Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total ocular score at 1 to 2 hours minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.
Time frame: Baseline and 1 to 2 hours post first use
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 2 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 0 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 0 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 1 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 1 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 2 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 7 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 37 Participants |
| Developmental Serum | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 1 | 0 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 1 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 2 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 2 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 1 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 32 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 4 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 7 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 1 | 0 Participants |
| Developmental Lotion | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 0 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0.5 | 2 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 1 | 1 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -3 | 0 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1 | 6 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2 | 0 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -0.5 | 4 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -2.5 | 1 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= -1.5 | 2 Participants |
| Developmental Cream | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | Total score= 0 | 35 Participants |
Secondary
Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use
The clinically relevant positive outcome for ocular irritation was defined as the number of participants who experienced an increase in total ocular irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The ophthalmologist assessment of signs and symptoms of ocular irritation total score was calculated as the sum of the individual ocular response attributes (eczema of the eyelid, conjunctivitis, follicles, and chemosis conjunctivae). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated the most severe condition.
Time frame: Day 21
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Developmental Serum | Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use | 0 Participants |
| Developmental Lotion | Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use | 0 Participants |
| Developmental Cream | Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use | 0 Participants |