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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Dapsone 5.0% Gel (Allergan); Drug: Dapsone 5.0% Gel (SEEGPharm); Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2361
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belize
  • Belize City, Belize
    • Catawba Clinical Research
• United States
  • California
    • Encino, California, United States, 91436
      • Catawba Clinical Research
    • Fullerton, California, United States, 92835
      • Catawba Clinical Research
    • La Mesa, California, United States, 91942
      • Catawba Clinical Research
    • Los Angeles, California, United States, 90017
      • Catawba Clinical Research
    • Los Angeles, California, United States, 90036
      • Catawba Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Catawba Clinical Research
    • Temecula, California, United States, 92592
      • Catawba Clinical Research
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Catawba Clinical Research
    • Brandon, Florida, United States, 33511
      • Catawba Clinical Research
    • Hialeah, Florida, United States, 33016
      • Catawba Clinical Research
    • Miami, Florida, United States, 33175
      • Catawba Clinical Research
    • Miramar, Florida, United States, 33027
      • Catawba Clinical Research
    • S Tampa, Florida, United States, 33609
      • Catawba Clinical Research
    • Tampa, Florida, United States, 33618
      • Catawba Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Catawba Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Catawba Clinical Research
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Catawba Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Catawba Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Catawba Clinical Research
    • Las Vegas, Nevada, United States, 89109
      • Catawba Clinical Research
    • Las Vegas, Nevada, United States, 89119
      • Catawba Clinical Research
  • New York
    • Endwell, New York, United States, 13760
      • Catawba Clinical Research
    • New York, New York, United States, 10012
      • Catawba Clinical Research
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Catawba Clinical Research
    • Wilmington, North Carolina, United States, 28405
      • Catawba Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Catawba Clinical Research
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Catawba Clinical Research
    • Upper St Clair, Pennsylvania, United States, 15241
      • Catawba Clinical Research
    • Warminster, Pennsylvania, United States, 18974
      • Catawba Clinical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Catawba Clinical Research
  • Texas
    • Austin, Texas, United States, 78746
      • Catawba Clinical Research
    • El Paso, Texas, United States, 79902
      • Catawba Clinical Research
    • Mesquite, Texas, United States, 75149
      • Catawba Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Catawba Clinical Research
  • Washington
    • Richland, Washington, United States, 97030
      • Catawba Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dapsone 5.0% Gel (Allergan); Dapsone 5.0% Gel applied twice daily for 84 days	Drug: Dapsone 5.0% Gel (Allergan); Topical Gel; Other Names: Active Comparator
Experimental: Dapsone 5.0% Gel (SEEGPharm); Dapsone 5.0% Gel applied twice daily for 84 days	Drug: Dapsone 5.0% Gel (SEEGPharm); Topical Gel; Other Names: Experimental Arm
Placebo Comparator: Placebo; Vehicle of Experimental Gel applied twice daily for 84 days	Other: Placebo; Topical Gel; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Seegpharm S.A.
• Investigators: Study Director: Karen Lewis, MS, Catawba Clinical Research

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone
• Other Study ID Numbers: SEEG-2015-6-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No