Clinical trial NCT02525549: Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 903
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
timeFrame: 84 days
measure: Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: