Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01182636
• Date of registration: 13/08/2010
• Prospective Registration: No
• Primary sponsor: Teva Pharmaceuticals USA
• Public title: Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
• Scientific 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
• Date of first enrolment: July 2007
• Target sample size: 601
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01182636
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
• Phase: Phase 1

Countries of recruitment

Belize, United States

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: Adapalene

Drug: Differin®

Drug: Placebo

Primary Outcome(s)

Safety Analysis [Time Frame: 84 Days]

Mean Percent Reduction from Baseline in Non-Inflamed Lesion Count [Time Frame: 84 days]

Mean Percent Reduction from Baseline in Non-Nodular Inflamed Lesion Count [Time Frame: 84 days]

Secondary Outcome(s)

Proportion of Patients Considered a "Clinical Success" or "Clinical Failure" [Time Frame: 84 Days]

Mean Numerical Reduction in Inflamed Lesion Counts [Time Frame: 84 Days]

Mean Numerical Reduction in Non-Inflamed Lesion Counts [Time Frame: 84 Days]

Secondary ID(s)

70716202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors