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

• ClinicalTrials.gov Identifier: NCT02865005
• Recruitment Status: Completed
• First Posted: August 12, 2016
• Last Update Posted: December 20, 2016
• Sponsor: Seegpharm S.A.
• Information provided by (Responsible Party): Seegpharm S.A.

Tracking Information

• First Submitted Date: July 1, 2016
• First Posted Date: August 12, 2016
• Last Update Posted Date: December 20, 2016
• Study Start Date: February 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2016)

Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts [ Time Frame: Treatment Days: 84 days of dosing ]

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 9, 2016)

Clinical Success: Proportion of subjects with a clinical response of "success" [ Time Frame: 12 Weeks ]

To evaluate as the proportion of subjects with a clinical response of "success" at Week 12.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 9, 2016)

• Safety Outcomes: Incidence of Adverse Events [ Time Frame: Baseline (Day 1) to Week 12 (Day 85) ]
  Analysis of the incidence of Adverse Events from Baseline (Day 1) to Week 12 (Day 85)
• Safety Outcomes: Change in Vital Signs [ Time Frame: Baseline (Day 1) to Week 12 (Day 85) ]
  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)
• Safety Outcomes: Local Skin/Application Site Reaction Scores [ Time Frame: Baseline (Day 1) to Week 12 (Day 85) ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
• 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
• Brief Summary: Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Drug: Dapsone 5.0% Gel (SEEGPharm)
  Topical Gel
  Other Name: Experimental Arm
• Other: Placebo
  Topical Gel
  Other Name: Placebo Comparator
• Drug: Dapsone 5.0% Gel (Allergan)
  Topical Gel
  Other Name: Active Comparator

Study Arms

• Active Comparator: Dapsone 5.0% Gel (Allergan)
  Dapsone 5.0% Gel applied twice daily for 84 days
  Intervention: Drug: Dapsone 5.0% Gel (Allergan)
• Experimental: Dapsone 5.0% Gel (SEEGPharm)
  Dapsone 5.0% Gel applied twice daily for 84 days
  Intervention: Drug: Dapsone 5.0% Gel (SEEGPharm)
• Placebo Comparator: Placebo
  Vehicle of Experimental Gel applied twice daily for 84 days
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2016): 2361
• Original Estimated Enrollment (submitted: August 9, 2016): 2260
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belize, United States

Administrative Information

• NCT Number: NCT02865005
• Other Study ID Numbers: SEEG-2015-6-23
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Seegpharm S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Seegpharm S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Karen Lewis, MS; Catawba Clinical Research

• PRS Account: Seegpharm S.A.
• Verification Date: December 2016