Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
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Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Actual Study Start Date :
December 13, 2017
Actual Primary Completion Date :
September 30, 2018
Actual Study Completion Date :
January 5, 2019
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Ages Eligible for Study:
12 Years to 40 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed IRB approved written informed consent/assent
12 to 40 years of age, inclusive.
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.
Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
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.
Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
Presence of more than 2 facial Nodulocystic lesions.
Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
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
Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.
Use of medications known to exacerbate acne
Start or change within 3 months (90 days) of Visit 1 and throughout the study
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
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.