Acne
Conditions
Brief summary
The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.
Interventions
DRUGAdapalene and Benzoyl Peroxide Gel (Reference)
DRUGPlacebo 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
* Male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris * Inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive) * Non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive) * No more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled. * Subjects must also have had a Baseline IGA score of 3 or 4 on a severity scale of 0 to 4 to be enrolled.
Exclusion criteria
* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. * Presence of more than 2 facial Nodulocystic lesions (i.e. nodules and cysts) * Subjects with active cystic acne or Polycystic Ovarian Syndrome * Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s). * Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. * Acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne, etc.) * Use of antipruritics including antihistamine, within 24 hours prior to all study visits (Visit l/Baseline through Visit 4). * Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion). * Use within 6 months prior to baseline or during the study of oral retinoids (e.g. Accutane') or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). * Use within 1 month prior to baseline or during the study of therapeutic vitamin D supplement (multivitamins are allowed). * Use within 1 month prior to baseline or during the study of 1) systemic sterOids', 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents. (' Intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose. Subjects may use Acetaminophen for pain relief, as needed, throughout the study) * Use within 14 days prior to baseline or during the study of 1) topical sterOids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparation (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical anti-inflammatory agents, or 7) topical antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions | 84 days |
| Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions | 84 days |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel | 365 |
| Reference Product Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference) | 360 |
| Placebo Product Placebo gel
Placebo gel | 178 |
| Total | 903 |
Baseline characteristics
| Characteristic | Test Product | Reference Product | Placebo Product | Total |
|---|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 6.25 | 20.4 years STANDARD_DEVIATION 6.96 | 19.5 years STANDARD_DEVIATION 6.55 | 20.0 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 59 Participants | 27 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 295 Participants | 301 Participants | 151 Participants | 747 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 | 4 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 19 Participants | 7 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 87 Participants | 34 Participants | 194 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 259 Participants | 245 Participants | 132 Participants | 636 Participants |
| Sex: Female, Male Female | 199 Participants | 213 Participants | 103 Participants | 515 Participants |
| Sex: Female, Male Male | 166 Participants | 147 Participants | 75 Participants | 388 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 365 | 0 / 360 | 0 / 178 |
| other Total, other adverse events | 0 / 365 | 0 / 360 | 0 / 178 |
| serious Total, serious adverse events | 0 / 365 | 2 / 360 | 2 / 178 |
Outcome results
Primary
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
Time frame: 84 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions | 61.07 percent change of lesion counts | Standard Deviation 36.6 |
| Reference Product | Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions | 65.58 percent change of lesion counts | Standard Deviation 28.42 |
| Placebo Product | Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions | 41.63 percent change of lesion counts | Standard Deviation 28.05 |
90% CI: [88.6, 102]Fieller's method
Primary
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
Time frame: 84 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions | 54.33 percent change of lesion counts | Standard Deviation 32 |
| Reference Product | Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions | 55.06 percent change of lesion counts | Standard Deviation 32.62 |
| Placebo Product | Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions | 36.40 percent change of lesion counts | Standard Deviation 38.61 |
90% CI: [92.3, 109.4]Fieller's method