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Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02709902
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
Bioequivalence with Clinical Endpoints.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene/BP gel, 0.3%/2.5% Drug: EPIDUO® FORTE Drug: Placebo Phase 1

Detailed Description:
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Start Date : September 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Experimental: Adapalene/BP gel, 0.3%/2.5%
Topical, once daily, for 84 days.
Drug: Adapalene/BP gel, 0.3%/2.5%
Gel
Other Name: Adapalene, benzoyl peroxide

Active Comparator: EPIDUO® FORTE
Topical, once daily, for 84 days.
Drug: EPIDUO® FORTE
Gel
Other Name: Adapalene, benzoyl peroxide

Placebo Comparator: Placebo
Topical, once daily, for 84 days.
Drug: Placebo
Gel
Other Name: Vehicle




Primary Outcome Measures :
  1. Change in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts


Secondary Outcome Measures :
  1. Clinical response of success [ Time Frame: Week 12 ]
    The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment



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
Criteria

Inclusion Criteria:

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

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): NCT02709902


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02709902     History of Changes
Other Study ID Numbers: ADBG 1519
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents