P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

Novan

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: SB204 4%; Drug: Vehicle Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667444

NI-AC302

Details and patient eligibility

About

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Full description

This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Enrollment: 1,330 patients

Sex: All

Ages: 9 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe acne
• Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
• Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion criteria

• Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
• Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,330 participants in 2 patient groups, including a placebo group

SB204 4%

Experimental group

Description:

SB204 4% topically once daily

Treatment:

Drug: SB204 4%

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel topically once daily

Treatment:

Drug: Vehicle Gel