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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.

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Dapsone 5.0% Gel (SEEGPharm) Other: Placebo Drug: Dapsone 5.0% Gel (Allergan) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

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 Name: 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 Name: Experimental Arm

Placebo Comparator: Placebo
Vehicle of Experimental Gel applied twice daily for 84 days
Other: Placebo
Topical Gel
Other Name: Placebo Comparator




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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.



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865005


Locations
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United States, California
Catawba Clinical Research
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
United States, Florida
Catawba Clinical Research
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
United States, Georgia
Catawba Clinical Research
Savannah, Georgia, United States, 31406
United States, Louisiana
Catawba Clinical Research
New Orleans, Louisiana, United States, 70130
United States, Nebraska
Catawba Clinical Research
Norfolk, Nebraska, United States, 68701
Catawba Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Catawba Clinical Research
Las Vegas, Nevada, United States, 89106
Catawba Clinical Research
Las Vegas, Nevada, United States, 89109
Catawba Clinical Research
Las Vegas, Nevada, United States, 89119
United States, New York
Catawba Clinical Research
Endwell, New York, United States, 13760
Catawba Clinical Research
New York, New York, United States, 10012
United States, North Carolina
Catawba Clinical Research
High Point, North Carolina, United States, 27262
Catawba Clinical Research
Wilmington, North Carolina, United States, 28405
United States, Ohio
Catawba Clinical Research
Cincinnati, Ohio, United States, 45246
United States, Pennsylvania
Catawba Clinical Research
Jenkintown, Pennsylvania, United States, 19046
Catawba Clinical Research
Upper St Clair, Pennsylvania, United States, 15241
Catawba Clinical Research
Warminster, Pennsylvania, United States, 18974
United States, Tennessee
Catawba Clinical Research
Nashville, Tennessee, United States, 37215
United States, Texas
Catawba Clinical Research
Austin, Texas, United States, 78746
Catawba Clinical Research
El Paso, Texas, United States, 79902
Catawba Clinical Research
Mesquite, Texas, United States, 75149
United States, Virginia
Catawba Clinical Research
Norfolk, Virginia, United States, 23507
United States, Washington
Catawba Clinical Research
Richland, Washington, United States, 97030
Belize
Catawba Clinical Research
Belize City, Belize
Sponsors and Collaborators
Seegpharm S.A.
Investigators
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Study Director: Karen Lewis, MS Catawba Clinical Research
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Responsible Party: Seegpharm S.A.
ClinicalTrials.gov Identifier: NCT02865005    
Other Study ID Numbers: SEEG-2015-6-23
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents