Status:
COMPLETED
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Lead Sponsor:
Padagis LLC
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-40 years
Phase:
PHASE3
Brief Summary
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2019
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT03393494
Start Date
December 13 2017
End Date
January 5 2019
Last Update
November 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology Consultants
High Point, North Carolina, United States, 27262