Clinical trial

A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

Name

NI-AC202

Description

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Trial arms

Trial start

2014-11-01

Estimated PCD

2015-06-01

Trial end

2015-08-01

Status

Completed

Phase

Early phase I

Treatment

SB204 2%

Applied topically twice daily

Arms:

SB204 2% Twice daily

Other names:

NVN1000

SB204 4%

Applied topically daily

Arms:

SB204 4% Twice Daily, SB204 4% daily

Other names:

NVN1000

Vehicle Gel

Applied topically twice and once daily

Arms:

Vehicle Gel Daily, Vehicle Gel Twice Daily

Other names:

Placeco

Size

213

Primary endpoint

Absolute Change in Inflammatory Lesion Counts

Baseline and Week 12

Absolute Change in Non-inflammatory Lesion Counts

Baseline and Week 12

Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment

Baseline and Week 12

Eligibility criteria

Inclusion Criteria: * Moderate to severe acne * 25-70 non-inflammatory lesions at Baseline * 20-40 inflammatory lesions at Baseline Exclusion Criteria: * Subjects with known allergy to any component of the test material or vehicle * Women who are pregnant or nursing

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 213, 'type': 'ACTUAL'}}

Updated at

2023-05-31

1 organization

2 products

1 indication

Product

Indication

Product

Organization