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

NCT ID: NCT02242760

Last Updated: 2023-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SB204 2% Twice daily

Twice daily SB204 2%

Group Type EXPERIMENTAL

SB204 2%

Intervention Type DRUG

Applied topically twice daily

SB204 4% daily

Once daily SB204 4%

Group Type EXPERIMENTAL

SB204 4%

Intervention Type DRUG

Applied topically daily

Vehicle Gel Daily

Vehicle Gel Daily

Group Type PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type DRUG

Applied topically twice and once daily

Vehicle Gel Twice Daily

Twice daily Vehicle Gel

Group Type PLACEBO_COMPARATOR

Vehicle Gel

Intervention Type DRUG

Applied topically twice and once daily

SB204 4% Twice Daily

Twice daily SB204 4%

Group Type EXPERIMENTAL

SB204 4%

Intervention Type DRUG

Applied topically daily

Interventions

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SB204 2%

Applied topically twice daily

Intervention Type DRUG

SB204 4%

Applied topically daily

Intervention Type DRUG

Vehicle Gel

Applied topically twice and once daily

Intervention Type DRUG

Other Intervention Names

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NVN1000 NVN1000 Placeco

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novan, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M J Rico, MD

Role: STUDY_DIRECTOR

Novan, Inc.

Locations

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Qst acne site #1

Hot Springs, Arkansas, United States

Site Status

QST Site #118

Encinitas, California, United States

Site Status

QST Site #111

San Diego, California, United States

Site Status

QST Site #113

San Diego, California, United States

Site Status

QST Site #119

Santa Monica, California, United States

Site Status

QST Site #103

Boca Raton, Florida, United States

Site Status

QST Site # 110

Pinellas Park, Florida, United States

Site Status

QST Site # 116

Newnan, Georgia, United States

Site Status

QST Site #117

Louisville, Kentucky, United States

Site Status

QST Site #112

Detroit, Michigan, United States

Site Status

QST Site #120

Warren, Michigan, United States

Site Status

QST Site # 121

Minneapolis, Minnesota, United States

Site Status

QST Site #107

New York, New York, United States

Site Status

QST Site #108

Rochester, New York, United States

Site Status

QST Site #109

Rochester, New York, United States

Site Status

QST Site #104

Stony Brook, New York, United States

Site Status

QST Site # 102

San Antonio, Texas, United States

Site Status

QST Site #106

Salt Lake City, Utah, United States

Site Status

QST #105

Lynchburg, Virginia, United States

Site Status

QST Site #114

Norfolk, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NI-AC202

Identifier Type: -

Identifier Source: org_study_id

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