NCT02525549CompletedPhase 3
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Padagis LLC
- Enrollment
- 903
- Primary Endpoint
- Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Test product
Experimental
Adapalene and Benzoyl Peroxide Gel
Intervention: Adapalene and Benzoyl Peroxide Gel (Drug)
Reference product
Active Comparator
Adapalene and Benzoyl Peroxide Gel (Reference)
Intervention: Adapalene and Benzoyl Peroxide Gel (Reference) (Drug)
Placebo product
Placebo Comparator
Placebo gel
Intervention: Placebo gel (Drug)
Outcomes
Primary Outcomes
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
Time Frame: 84 days
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
Time Frame: 84 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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