P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242760
• Other study ID #: NI-AC202
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2023
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• SB204 2%
Applied topically twice daily
• SB204 4%
Applied topically daily
• Vehicle Gel
Applied topically twice and once daily

Locations

Country	Name	City	State
United States	QST Site #103	Boca Raton	Florida
United States	QST Site #112	Detroit	Michigan
United States	QST Site #118	Encinitas	California
United States	Qst acne site #1	Hot Springs	Arkansas
United States	QST Site #117	Louisville	Kentucky
United States	QST #105	Lynchburg	Virginia
United States	QST Site # 121	Minneapolis	Minnesota
United States	QST Site #107	New York	New York
United States	QST Site # 116	Newnan	Georgia
United States	QST Site #114	Norfolk	Virginia
United States	QST Site # 110	Pinellas Park	Florida
United States	QST Site #108	Rochester	New York
United States	QST Site #109	Rochester	New York
United States	QST Site #106	Salt Lake City	Utah
United States	QST Site # 102	San Antonio	Texas
United States	QST Site #111	San Diego	California
United States	QST Site #113	San Diego	California
United States	QST Site #119	Santa Monica	California
United States	QST Site #104	Stony Brook	New York
United States	QST Site #120	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Inflammatory Lesion Counts	Change in inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Primary	Absolute Change in Non-inflammatory Lesion Counts	Absolute Change in non-inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Primary	Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment	Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.; Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)	Baseline and Week 12
Secondary	Percent Change in Inflammatory Lesion Count From Baseline to Week 12	The percent change in inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Secondary	Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12	The percent change in non-inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Secondary	Median Time to Improvement	Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.	Baseline through Week 12