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Phase 3 N=825 Randomized Double-blind Treatment

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

Acne Vulgaris

Enrolled (actual)
825
Serious AEs
0.2%
Results posted
Jan 2021
Primary outcome: Primary: Mean Percent Change From Baseline in the Papules and Pustules Lesion Count — 68.18; 63.56; 50.72 percentage of lesion change

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Adapalene and Benzoyl Peroxide Topical Gel (Drug); Epiduo Topical Product (Drug); Placebo (Drug)
Age
Pediatric, Adult · 12+ yrs
Sex
All
Sponsor
Padagis LLC
Primary completion
Sep 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
68.18; 63.56; 50.72
PRIMARY
Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
62.75; 60.78; 43.45 0.05

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 Criteria

  • 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 Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03393494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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