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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393494
Recruitment Status : Completed
First Posted : January 8, 2018
Results First Posted : January 5, 2021
Last Update Posted : November 8, 2021
Information provided by (Responsible Party):
Padagis LLC

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene and Benzoyl Peroxide Topical Gel Drug: Epiduo Topical Product Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : January 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Experimental: Perrigo active
Test product
Drug: Adapalene and Benzoyl Peroxide Topical Gel
Test product

Active Comparator: Reference active
RLD product
Drug: Epiduo Topical Product
RLD product

Placebo Comparator: Perrigo placebo
placebo product
Drug: Placebo
Placebo gel

Primary Outcome Measures :
  1. Mean Percent Change From Baseline in the Papules and Pustules Lesion Count [ Time Frame: Day 1 to week 12 ]
  2. Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count [ Time Frame: Day 1 to week 12 ]
    Per protocol population

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393494

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United States, North Carolina
Dermatology Consultants
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Padagis LLC
  Study Documents (Full-Text)

Documents provided by Padagis LLC:
Study Protocol  [PDF] September 28, 2017
Statistical Analysis Plan  [PDF] September 28, 2017

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Responsible Party: Padagis LLC
ClinicalTrials.gov Identifier: NCT03393494    
Other Study ID Numbers: PRG-NY-17-008
First Posted: January 8, 2018    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents