Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865005
• Other study ID #: SEEG-2015-6-23
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2016
• Last updated: December 19, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Seegpharm S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Description:

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2361
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy male or non-pregnant females aged = 12 and = 40 years of age with a clinical diagnosis of acne vulgaris.

• Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.

• On the face, subjects must have = 20 inflammatory lesions (i.e., papules and pustules), AND = 25 non-inflammatory lesions (open and closed comedones) AND = 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.

• Subjects must have an acne severity grade of 3 or 4 per the IGA

• Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.

Exclusion Criteria:

• Prior or current concomitant therapies that would interfere with assessments in the study.

• Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.

• Prior, current or planned procedures that would interfere with assessments in the study.

• Current or planned activities that would interfere with assessment in the study.

• Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Dapsone 5.0% Gel (SEEGPharm)
Topical Gel

Other:
• Placebo
Topical Gel

Drug:
• Dapsone 5.0% Gel (Allergan)
Topical Gel

Locations

Country	Name	City	State
Belize	Catawba Clinical Research	Belize City
United States	Catawba Clinical Research	Austin	Texas
United States	Catawba Clinical Research	Boca Raton	Florida
United States	Catawba Clinical Research	Brandon	Florida
United States	Catawba Clinical Research	Cincinnati	Ohio
United States	Catawba Clinical Research	El Paso	Texas
United States	Catawba Clinical Research	Encino	California
United States	Catawba Clinical Research	Endwell	New York
United States	Catawba Clinical Research	Fullerton	California
United States	Catawba Clinical Research	Hialeah	Florida
United States	Catawba Clinical Research	High Point	North Carolina
United States	Catawba Clinical Research	Jenkintown	Pennsylvania
United States	Catawba Clinical Research	La Mesa	California
United States	Catawba Clinical Research	Las Vegas	Nevada
United States	Catawba Clinical Research	Las Vegas	Nevada
United States	Catawba Clinical Research	Las Vegas	Nevada
United States	Catawba Clinical Research	Los Angeles	California
United States	Catawba Clinical Research	Los Angeles	California
United States	Catawba Clinical Research	Mesquite	Texas
United States	Catawba Clinical Research	Miami	Florida
United States	Catawba Clinical Research	Miramar	Florida
United States	Catawba Clinical Research	Nashville	Tennessee
United States	Catawba Clinical Research	New Orleans	Louisiana
United States	Catawba Clinical Research	New York	New York
United States	Catawba Clinical Research	Norfolk	Nebraska
United States	Catawba Clinical Research	Norfolk	Virginia
United States	Catawba Clinical Research	Omaha	Nebraska
United States	Catawba Clinical Research	Richland	Washington
United States	Catawba Clinical Research	S Tampa	Florida
United States	Catawba Clinical Research	Savannah	Georgia
United States	Catawba Clinical Research	Sherman Oaks	California
United States	Catawba Clinical Research	Tampa	Florida
United States	Catawba Clinical Research	Temecula	California
United States	Catawba Clinical Research	Upper St Clair	Pennsylvania
United States	Catawba Clinical Research	Warminster	Pennsylvania
United States	Catawba Clinical Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seegpharm S.A.

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcomes: Incidence of Adverse Events	Analysis of the incidence of Adverse Events from Baseline (Day 1) to Week 12 (Day 85)	Baseline (Day 1) to Week 12 (Day 85)	No
Other	Safety Outcomes: Change in Vital Signs	Clinically Significant Changes in Body temperature (oral), pulse rate (sitting), blood pressure (sitting systolic and diastolic) from Baseline (Day 1) to Week 12 (Day 85)	Baseline (Day 1) to Week 12 (Day 85)	No
Other	Safety Outcomes: Local Skin/Application Site Reaction Scores	Application (local skin) sites will be assessed at each visit and scored using the local skin site reaction scores (0=Absent, 1=Mild, 2=Moderate, 3=Severe) for the following signs and symptoms of irritation: erythema, dryness, burning/stinging, erosion, edema, pain, and itching, for comparisons between groups.	Baseline (Day 1) to Week 12 (Day 85)	No
Primary	Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts	To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT)	Treatment Days: 84 days of dosing	No
Secondary	Clinical Success: Proportion of subjects with a clinical response of "success"	To evaluate as the proportion of subjects with a clinical response of "success" at Week 12.	12 Weeks	No