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

NCT ID: NCT03393494

Last Updated: 2021-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2019-01-05

Brief Summary

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

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Perrigo active

Test product

Group Type EXPERIMENTAL

Adapalene and Benzoyl Peroxide Topical Gel

Intervention Type DRUG

Test product

Reference active

RLD product

Group Type ACTIVE_COMPARATOR

Epiduo Topical Product

Intervention Type DRUG

RLD product

Perrigo placebo

placebo product

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo gel

Interventions

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Adapalene and Benzoyl Peroxide Topical Gel

Test product

Intervention Type DRUG

Epiduo Topical Product

RLD product

Intervention Type DRUG

Placebo

Placebo gel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatology Consultants

High Point, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PRG-NY-17-008

Identifier Type: -

Identifier Source: org_study_id