Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: CLPG Topical Gel 1%; Drug: Placebo; Drug: Clindamycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04134273

CLPG 1809

Details and patient eligibility

About

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Full description

The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Enrollment: 1,260 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
• Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
• Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,260 participants in 3 patient groups, including a placebo group

CLPG Topical Gel 1%

Experimental group

Description:

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Treatment:

Drug: CLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1%

Active Comparator group

Description:

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Treatment:

Drug: Clindamycin

Vehicle of the test product

Placebo Comparator group

Description:

Placebo (vehicle of the test product), applied to the face twice a day for 84 days.

Treatment:

Drug: Placebo