P3 Study in Acne Comparing Once Daily SB204 and Vehicle

Novan, Inc.1,307 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,307

Conditions

Acne Vulgaris

Interventions

SB204 4%DRUG

Once daily

Vehicle GelDRUG

Placebo comparator

Eligibility

Sex: ALLMin age: 9 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (55)

Outcomes

Primary Outcomes

Absolute Change From Baseline in Inflammatory Lesion Counts

The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.

Time frame: Baseline and Week 12

Absolute Change From Baseline in Non-inflammatory Lesion Counts

The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).

Time frame: Baseline and Week 12

Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12

Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. 1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). 2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. 3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. 4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions

Time frame: Baseline and Week 12

Secondary Outcomes

Percent Change in Inflammatory Lesion Count

The percent change from baseline in inflammatory lesion count

Time frame: Baseline and Week 12

Percent Change in Non-inflammatory Lesion Count

The percent change from baseline in non-inflammatory lesion count

Data from ClinicalTrials.gov

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