Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Double-Blind, Multiple-Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the Bioequivalence of Adapalene Gel 0.1% (PLIVA Research & Development Ltd.) Compared to Differin® (Adapalene 0.1%) Topical Gel (Galderma Laboratories) in Patients With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182636
• Other study ID #: 70716202
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2010
• Last updated: November 22, 2010
• Start date: July 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2010
• Source: Teva Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint Studies.

Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical Endpoint Studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene
0.1% Topical Gel
• Differin®
0.1% Topical Gel
• Placebo
Gel Base

Locations

Country	Name	City	State
Belize	Dermatology and Skin Surgery Centre	Belize City
Belize	FXM Research International	Belize City
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Arlington Center for Dermatology	Arlington	Texas
United States	SNBL Clinical Pharmacology Center, Inc.	Baltimore	Maryland
United States	University Dermatology Consultants, Inc.	Cincinnati	Ohio
United States	Michigan Center for Research Corportation	Clinton Township	Michigan
United States	Cherry Creek Research, Inc.	Denver	Colorado
United States	Office of Zoe Diana Draelos, MD	High Point	North Carolina
United States	Center for Clinical Studies	Houston	Texas
United States	Center for Clinical Studies	Houston	Texas
United States	Knoxville Dermatology, PC	Knoxville	Tennessee
United States	Office of Atoya Breona Adams, MD	Las Vegas	Nevada
United States	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Dermatology Research Associates	Los Angeles	California
United States	Aurora Advanced Healthcare, Inc.	Milwaukee	Wisconsin
United States	MedaPhase, Inc.	Newnan	Georgia
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Novum Pharmaceutical Research Services	Pittsburgh	Pennsylvania
United States	Dermatology Associates of Rochester, PC	Rochester	New York
United States	Helendale Dermatology & Medical Spa, LLC	Rochester	New York
United States	Dermatology Associates of Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceuticals USA

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	Yes
Secondary	Mean Numerical Reduction in Inflamed Lesion Counts	Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.	84 Days	No
Secondary	Mean Numerical Reduction in Non-Inflamed Lesion Counts	Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population.	84 Days	No
Secondary	Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"	Secondary measure of bioequivalence using the Intent-to-Treat (ITT) population. "Clinial Success" or "Clinical Failure" is defined by the Physician's Global Assessment.	84 Days	No