A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Onexton™ Gel; Drug: Placebo; Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02578043

CLBG 1508

Details and patient eligibility

About

The objectives of this study are to evaluate the therapeutic equivalence and safety.

Full description

The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Enrollment: 844 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion criteria

• Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
• A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
• A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

844 participants in 3 patient groups, including a placebo group

Clindamycin and BPO Gel 1.2%/3.75%

Experimental group

Description:

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.

Treatment:

Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Onexton™ Gel

Active Comparator group

Description:

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.

Treatment:

Drug: Onexton™ Gel

Placebo

Placebo Comparator group

Description:

Placebo (vehicle of the test product) applied to the face once daily for 84 days.

Treatment:

Drug: Placebo