Clinical trial NCT01182636: Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Bioequivalence
Acne Vulgaris
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 601
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count
timeFrame: 84 days
measure: Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count
timeFrame: 84 days
measure: Safety Analysis
timeFrame: 84 Days
Secondary outcomes:
measure: Mean Numerical Reduction in Inflamed Lesion Counts
timeFrame: 84 Days
measure: Mean Numerical Reduction in Non-Inflamed Lesion Counts
timeFrame: 84 Days
measure: Proportion of Patients Considered a "Clinical Success" or "Clinical Failure"
timeFrame: 84 Days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center, Inc.
state: Maryland
city: Clinton Township
country: United States
facility: Michigan Center for Research Corportation
state: Michigan
city: Las Vegas
country: United States
facility: Office of Atoya Breona Adams, MD
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Helendale Dermatology & Medical Spa, LLC
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: High Point
country: United States
facility: Office of Zoe Diana Draelos, MD
state: North Carolina
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Pittsburgh
country: United States
facility: Novum Pharmaceutical Research Services
state: Pennsylvania
city: Knoxville
country: United States
facility: Knoxville Dermatology, PC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler
state: Texas
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc.
state: Wisconsin
city: Belize City
country: Belize
facility: Dermatology and Skin Surgery Centre
city: Belize City
country: Belize
facility: FXM Research International
Study officials:
References: