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Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02525549
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

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.

Condition or disease Intervention/treatment Phase
Acne Drug: Adapalene and Benzoyl Peroxide Gel Drug: Adapalene and Benzoyl Peroxide Gel (Reference) Drug: Placebo gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 903 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Test product
Adapalene and Benzoyl Peroxide Gel
Drug: Adapalene and Benzoyl Peroxide Gel
Active Comparator: Reference product
Adapalene and Benzoyl Peroxide Gel (Reference)
Drug: Adapalene and Benzoyl Peroxide Gel (Reference)
Placebo Comparator: Placebo product
Placebo gel
Drug: Placebo gel



Primary Outcome Measures :
  1. Mean percent change from Baseline in inflammatory (papules and pustules) lesions [ Time Frame: 84 days ]
  2. Mean percent change from Baseline in non-inflammatory (open and closed comedones) lesions [ Time Frame: 84 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT02525549     History of Changes
Other Study ID Numbers: PRG-817
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Adapalene
Benzoyl Peroxide
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents