Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face

Padagis

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Epiduo Topical Product; Drug: Adapalene and Benzoyl Peroxide Topical Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03393494

PRG-NY-17-008

Details and patient eligibility

About

To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris

Enrollment: 825 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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825 participants in 3 patient groups, including a placebo group

Perrigo active

Experimental group

Description:

Test product

Treatment:

Drug: Adapalene and Benzoyl Peroxide Topical Gel

Reference active

Active Comparator group

Description:

RLD product

Treatment:

Drug: Epiduo Topical Product

Perrigo placebo

Placebo Comparator group

Description:

placebo product

Treatment:

Drug: Placebo