Clinical trial

A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

Name

NI-AC302

Description

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.

Trial arms

Trial start

2016-02-19

Estimated PCD

2016-12-01

Trial end

2016-12-09

Status

Completed

Phase

Early phase I

Treatment

SB204 4%

Applied topically once daily

Arms:

SB204 4%

Other names:

NVN1000

Vehicle Gel

Applied topically one daily

Arms:

Vehicle Gel

Other names:

Placebo

Size

1330

Primary endpoint

Absolute Change From Baseline in Inflammatory Lesion Counts

Baseline and Week 12

Absolute Change From Baseline in Non-inflammatory Lesion Counts

Baseline and Week 12

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

Week 12

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1330, 'type': 'ACTUAL'}}

Updated at

2023-07-24

1 organization

2 products

1 indication

Organization

Product

Indication

Product