Acne Vulgaris
Conditions
Brief summary
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
Interventions
DRUGAdapalene and Benzoyl Peroxide Topical Gel
Test product
DRUGEpiduo Topical Product
RLD product
DRUGPlacebo
Placebo gel
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Signed IRB approved written informed consent/assent 2. 12 to 40 years of age, inclusive. 3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose. 4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4. 5. Females of child bearing potential (excluding women who are surgically sterilized (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/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Exclusion criteria
1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. 2. Presence of more than 2 facial Nodulocystic lesions. 3. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations 4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments 5. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris. 6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy. 7. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family. 8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication. 9. Use of medications known to exacerbate acne 10. Start or change within 3 months (90 days) of Visit 1 and throughout the study 11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study 12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. 13. 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 | Description |
|---|---|---|
| Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | Day 1 to week 12 | — |
| Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | Day 1 to week 12 | Per protocol population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perrigo Active Test product
Adapalene and Benzoyl Peroxide Topical Gel: Test product | 329 |
| Reference Active RLD product
Epiduo Topical Product: RLD product | 331 |
| Perrigo Placebo placebo product
Placebo: Placebo gel | 165 |
| Total | 825 |
Baseline characteristics
| Characteristic | Perrigo Active | Reference Active | Perrigo Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 160 Participants | 161 Participants | 76 Participants | 397 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants | 170 Participants | 89 Participants | 428 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 126 Participants | 120 Participants | 53 Participants | 299 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants | 211 Participants | 112 Participants | 526 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 6 Participants | 4 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 48 Participants | 30 Participants | 129 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 | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 19 Participants | 9 Participants | 49 Participants |
| Race (NIH/OMB) White | 241 Participants | 256 Participants | 122 Participants | 619 Participants |
| Sex: Female, Male Female | 117 Participants | 129 Participants | 69 Participants | 315 Participants |
| Sex: Female, Male Male | 212 Participants | 202 Participants | 96 Participants | 510 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 331 | 0 / 165 |
| other Total, other adverse events | 0 / 329 | 0 / 331 | 0 / 165 |
| serious Total, serious adverse events | 0 / 329 | 0 / 331 | 2 / 165 |
Outcome results
Primary
Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
Per protocol population
Time frame: Day 1 to week 12
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perrigo Active | Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | 62.75 percentage of lesion change | Standard Deviation 28.09 |
| Reference Active | Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | 60.78 percentage of lesion change | Standard Deviation 33.73 |
| Perrigo Placebo | Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | 43.45 percentage of lesion change | Standard Deviation 36.3 |
p-value: 0.0590% CI: [94.1, 108.5]Fieller's method
Primary
Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
Time frame: Day 1 to week 12
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perrigo Active | Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | 68.18 percentage of lesion change | Standard Deviation 28.96 |
| Reference Active | Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | 63.56 percentage of lesion change | Standard Deviation 31.57 |
| Perrigo Placebo | Mean Percent Change From Baseline in the Papules and Pustules Lesion Count | 50.72 percentage of lesion change | Standard Deviation 35.12 |
90% CI: [97.8, 112.2]Fieller's method