Rosacea
Conditions
Brief summary
The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of inflammatory lesions rosacea
Interventions
DRUGIvermectin
DRUGIvermectin (reference)
DRUGPlacebo
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Must be at least 18 years of age 3. Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea 4. Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed. 5. Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations. 6. Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.
Exclusion criteria
1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation. 2. Current or past ocular rosacea. 3. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment. 4. History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication. 5. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline). 6. Current use of anticoagulation therapy and use throughout the study. 7. Use of medicated make-up (including anti-aging make-up) throughout the study 8. Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators). 9. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics. 10. Use of medicated cleansers on the face (throughout the study. 11. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements 12. Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study. 13. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits. 14. Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study. 15. Previous enrollment in this study or current enrollment in this study at another participating site. 16. Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study. 17. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | Day 1 to Day 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Clinical Success on the Investigator Global Assessment | Day 1 to Day 84 | Clinical success is defined as a score of clear or almost clear |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product Ivermectin Cream, 1% (Perrigo) | 193 |
| Reference Product Ivermectin Cream, 1% (reference) | 193 |
| Placebo Placebo cream | 100 |
| Total | 486 |
Baseline characteristics
| Characteristic | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 12.65 | 51.3 years STANDARD_DEVIATION 13.61 | 51.2 years STANDARD_DEVIATION 14.25 | 51.5 years STANDARD_DEVIATION 13.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 37 Participants | 19 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 156 Participants | 81 Participants | 392 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 188 Participants | 189 Participants | 97 Participants | 474 Participants |
| Sex: Female, Male Female | 141 Participants | 140 Participants | 67 Participants | 348 Participants |
| Sex: Female, Male Male | 52 Participants | 53 Participants | 33 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 193 | 0 / 193 | 0 / 100 |
| other Total, other adverse events | 0 / 193 | 0 / 193 | 0 / 100 |
| serious Total, serious adverse events | 0 / 193 | 0 / 193 | 0 / 100 |
Outcome results
Primary
Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count
Time frame: Day 1 to Day 84
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | 65.47 percentage of lesion reduction | Standard Deviation 30.222 |
| Reference Product | Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | 67.89 percentage of lesion reduction | Standard Deviation 30.244 |
| Placebo | Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count | 55.51 percentage of lesion reduction | Standard Deviation 32.66 |
90% CI: [91, 105.4]ANOVA
Secondary
Subjects With Clinical Success on the Investigator Global Assessment
Clinical success is defined as a score of clear or almost clear
Time frame: Day 1 to Day 84
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Product | Subjects With Clinical Success on the Investigator Global Assessment | 71 Participants |
| Reference Product | Subjects With Clinical Success on the Investigator Global Assessment | 79 Participants |
| Placebo | Subjects With Clinical Success on the Investigator Global Assessment | 26 Participants |
90% CI: [-18.31, 1.85]Wald's method