Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02865005
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Seegpharm S.A.

Tracking Information
First Submitted Date  ICMJE July 1, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date December 20, 2016
Study Start Date  ICMJE February 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2016)
2361
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
2260
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belize,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02865005
Other Study ID Numbers  ICMJE SEEG-2015-6-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seegpharm S.A.
Study Sponsor  ICMJE Seegpharm S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Lewis, MS Catawba Clinical Research
PRS Account Seegpharm S.A.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP