Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris

Seegpharm

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone 5.0% Gel (Allergan); Other: Placebo; Drug: Dapsone 5.0% Gel (SEEGPharm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02865005

SEEG-2015-6-23

Details and patient eligibility

About

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Full description

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.

Enrollment: 2,361 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
• Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
• On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
• Subjects must have an acne severity grade of 3 or 4 per the IGA
• Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.

Exclusion criteria

• Prior or current concomitant therapies that would interfere with assessments in the study.
• Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
• Prior, current or planned procedures that would interfere with assessments in the study.
• Current or planned activities that would interfere with assessment in the study.
• Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2,361 participants in 3 patient groups, including a placebo group

Dapsone 5.0% Gel (Allergan)

Active Comparator group

Description:

Dapsone 5.0% Gel applied twice daily for 84 days

Treatment:

Drug: Dapsone 5.0% Gel (Allergan)

Dapsone 5.0% Gel (SEEGPharm)

Experimental group

Description:

Dapsone 5.0% Gel applied twice daily for 84 days

Treatment:

Drug: Dapsone 5.0% Gel (SEEGPharm)

Placebo

Placebo Comparator group

Description:

Vehicle of Experimental Gel applied twice daily for 84 days

Treatment:

Other: Placebo