Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - 40 |
Updated: | 1/11/2019 |
Start Date: | December 13, 2017 |
End Date: | January 5, 2019 |
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
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the
treatment of Acne Vulgaris
treatment of Acne Vulgaris
Inclusion Criteria:
1. Signed IRB approved written informed consent/assent
2. 12 to 40 years of age, inclusive.
3. 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.
4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a
severity scale of 0 to 4.
5. 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.
Exclusion Criteria:
1. Pregnant, breastfeeding or planning a pregnancy within the period of their study
participation period.
2. Presence of more than 2 facial Nodulocystic lesions.
3. Presence of any other facial skin condition that, in the Investigator's opinion, might
interfere with acne vulgaris diagnosis and/or evaluations
4. 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
5. Excessive facial hair that would interfere with the diagnosis or assessment of acne
vulgaris.
6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
7. Currently using any product containing adapalene and/or benzoyl peroxide and/or
belonging to the same family.
8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids
and/or any ingredient in the study medication.
9. Use of medications known to exacerbate acne
10. Start or change within 3 months (90 days) of Visit 1 and throughout the study
11. 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
12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
compromise the subject's ability to comply with study requirements.
13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the
restrictions of the protocol and complete the study.
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