Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

NCT01182636 | Completed Phase 1

• 1 other identifier: 70716202
• Study Type: interventional
• Target: 601
• Locations: 2 countries
• Sites: 22

Brief Summary

The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.

Conditions

Acne Vulgaris

Keywords

Bioequivalence; Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count

  Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.

  84 days

• Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count

  Per Protocol Population (PPP) was assessed for the mean percent reduction in non-inflamed lesion count (open and closed comedones) compared with baseline at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.

  84 days

• Safety Analysis

  All 601 patients randomized and dispensed study drug were included in the safety analysis. The frequency, severity, and relationship to the study drug for adverse events in each treatment group were used to compare the safety of the study medications.

  84 Days

Secondary Outcomes (3)

• Mean Numerical Reduction in Inflamed Lesion Counts

  84 Days

• Mean Numerical Reduction in Non-Inflamed Lesion Counts

  84 Days

• Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"

  84 Days

Study Arms (3)

Investigational Test Product

EXPERIMENTAL

Adapalene Topical Gel, 0.1%

Drug: Adapalene

Reference Listed Drug

ACTIVE COMPARATOR

Differin® (adapalene 0.1%) Topical Gel

Drug: Differin®

Placebo

PLACEBO COMPARATOR

Gel base only

Drug: Placebo

Interventions

Adapalene DRUG

0.1% Topical Gel

Investigational Test Product

Differin® DRUG

0.1% Topical Gel

Also known as: Adapalene

Reference Listed Drug

Placebo DRUG

Gel Base

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or non-pregnant, non-lactating female, 12-40 years of age inclusive.
• Signed informed consent form, which meets all the criteria of the current FDA regulations. For patients under the age of majority in the state they are enrolled, the patient's parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
• If female and of child bearing potential, prepare to abstain from sexual intercourse or use reliable method of contraception during the study (i.e. condom, Intrauterine device, hormonal contraceptives). Patients on hormonal contraceptives must have been on the same hormonal contraceptive for 3 months prior to the baseline visit and continue throughout the duration of the study.
• Have moderate to severe facial acne as defines as: at least 20 but no more that 60 facial inflammatory lesions (papules and pustules) and at least 25 but no more than 100 non-inflamed lesions (open and closed comedones) and have a Physician's Global Assessment score of 3, 4, or 5.

You may not qualify if:

• Patient has more than 2 facial nodular lesions, any nodules present will be documented but will not be included in the inflammatory lesion count.
• Patient has active cystic acne.
• Patient has acne conglobate.
• Patient with significant facial hair such as beards or tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
• Patients with facial sunburn.
• Any dermatological condition other than acne vulgaris that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne (e.g. rosacea, psoriasis, dermatitis).
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of allergy or sensitivity to adapalene or other retinoids, or history of any drug hypersensitivity or intolerance which, in the Investigator's opinion, would compromise the safety of the patient or the study.
• Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participation.
• Use of any topical antibiotics, topical steroids, or topical anti-inflammatory products used on the face, any oral antibiotics known to treat acne, any systemic steroids, or any systemic anti-inflammatory agents (other than the use of non-steroidal anti-inflammatory agents) within 28 days of the first dosing day.
• Use of oral isotretinoin (Accutane®) within 6 months. Use of topical tretinoin (Retin-A®), adapalene (Differin®), tazarotene (Tazorac®), or azelaic acid (Azelex®) within 28 days of the first dosing day.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Female patients who are using hormonal contraceptives must have been on the same type and strength of hormonal contraceptive for at least 3 months prior to enrollment in the study and throughout the duration of the study.
• Patients should not use any medicated facial products (soaps, lotions, moisturizers, etc.) or other medicated facial cleansing agents for 14 days prior to study enrollment.
• Previous participation in this study.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (22)

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

University Clinical Research, Inc.

Pembroke Pines, Florida, 33024, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

Michigan Center for Research Corportation

Clinton Township, Michigan, 48038, United States

Location

Office of Atoya Breona Adams, MD

Las Vegas, Nevada, 89119, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Helendale Dermatology & Medical Spa, LLC

Rochester, New York, 14609, United States

Location

Dermatology Associates of Rochester, PC

Rochester, New York, 14623, United States

Location

Office of Zoe Diana Draelos, MD

High Point, North Carolina, 27262, United States

Location

University Dermatology Consultants, Inc.

Cincinnati, Ohio, 45219, United States

Location

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

Knoxville Dermatology, PC

Knoxville, Tennessee, 37920, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Center for Clinical Studies

Houston, Texas, 77058, United States

Location

Dermatology Associates of Tyler

Tyler, Texas, 75701, United States

Location

Aurora Advanced Healthcare, Inc.

Milwaukee, Wisconsin, 53209, United States

Location

Dermatology and Skin Surgery Centre

Belize City, Belize

Location

FXM Research International

Belize City, Belize

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: November 24, 2010

Record last verified: 2010-11

Locations

BE (2); US (20)