Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01182636
Other study ID # 70716202
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Completed NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4