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Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo� and Both to a Placebo Control in the Treatment of Acne Vulgaris

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Drug); Epiduo® Gel (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

Summary

The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0. 1%/2. 5% Gel (Taro Pharmaceuticals Inc.) and Epiduo (Adapalene and Benzoyl Peroxide 0. 1%/2. 5% Gel) (Galderma Laboratories, L. P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.

Clinical Details

Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) and Both Active Treatments to a Placebo in the Treatment of Acne Vulgaris.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Inflammatory and non-inflammatory lesion counts

Secondary outcome: Clinical response of success.

Eligibility

Minimum age: 12 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical

diagnosis of acne vulgaris.

- Subjects who are 18 years of age or older must have provided written informed

consent. Subjects 12 to 17 years of age must have provided written assent, which must be accompanied by written informed consent from the subject's legally acceptable representative. All subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act authorization.

- Subjects must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory

lesions and ≤ 2 nodulocystic lesions, at baseline on the face.

- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2,

3, or 4 as per the Investigator's Global Assessment (IGA).

- Subjects must be willing to refrain from using all other topical acne medications or

antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.

- Female subjects of childbearing potential (excluding those who are surgically

sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.

- All male subjects must agree to use accepted methods of birth control with their

partners, from the day of the first dose administration to 30 days after the last administration of study drug.

- Subjects must be willing and able to understand and comply with the requirements of

the protocol.

- Subjects must be in good health and free from any clinically significant disease,

including but not limited to, conditions that may interfere with the evaluation of acne vulgaris.

- Subjects who use make-up must have used the same brands/types for a minimum period of

14 days prior to study entry and must agree to not change brand/type or frequency of use throughout the study. Exclusion Criteria:

- Female subjects who are pregnant, nursing or planning to become pregnant during study

participation.

- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or

any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excipients.

- Subjects with the presence of any skin condition that would interfere with the

diagnosis or assessment of acne vulgaris.

- Subjects with excessive facial hair that would interfere with diagnosis or assessment

of acne vulgaris.

- Subjects who have performed wax depilation of the face within 14 days prior to

baseline.

- Subjects who have used within 6 months prior to baseline or use during the study of

oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day.

- Subjects who have used estrogens or oral contraceptives for less than 3 months prior

to baseline.

- Subjects who have used any of the following procedures on the face within 1 month

prior to baseline or use during the study: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy.

- Subjects who have used any of the following treatments within 1 month prior to

baseline or use during the study: systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents.

- Subjects who have used any of the following treatments within 2 weeks prior to

baseline or during the study: topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics.

- Use of spironolactone is prohibited during the study.

- Use of tanning booths, sunbathing, or excessive exposure to the sun are prohibited

during the study.

- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90

days prior to baseline.

- Subjects who have unstable medical disorders that are clinically significant or have

life-threatening diseases.

- Subjects who have on-going malignancies requiring systemic treatment, and subjects

who have any malignancy of the skin of the facial area.

- Subjects who engage in activities that involve excessive or prolonged exposure to

sunlight or weather extremes, such as wind or cold.

- Subjects who consume excessive amounts of alcohol or use drugs of abuse.

- Subjects who have participated in an investigational drug study within 30 days prior

to baseline.

- Subjects who have been previously enrolled in this study.

- Subjects who have had laser therapy, electrodesiccation and phototherapy to the

facial area within 180 days prior to study entry.

- Subjects who have had cosmetic procedures which may affect the efficacy and safety

profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.

- Subjects who currently have or have recently had bacterial folliculitis on the face.

Locations and Contacts

Additional Information

Starting date: October 2012
Last updated: March 8, 2014

Page last updated: August 23, 2015

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