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

Sponsor
Seegpharm S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT02865005
Collaborator
(none)
2,361
Enrollment
36
Locations
3
Arms
10
Duration (Months)
65.6
Patients Per Site
6.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    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 [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" [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catawba Clinical Research Encino California United States 91436
    2 Catawba Clinical Research Fullerton California United States 92835
    3 Catawba Clinical Research La Mesa California United States 91942
    4 Catawba Clinical Research Los Angeles California United States 90017
    5 Catawba Clinical Research Los Angeles California United States 90036
    6 Catawba Clinical Research Sherman Oaks California United States 91403
    7 Catawba Clinical Research Temecula California United States 92592
    8 Catawba Clinical Research Boca Raton Florida United States 33486
    9 Catawba Clinical Research Brandon Florida United States 33511
    10 Catawba Clinical Research Hialeah Florida United States 33016
    11 Catawba Clinical Research Miami Florida United States 33175
    12 Catawba Clinical Research Miramar Florida United States 33027
    13 Catawba Clinical Research S Tampa Florida United States 33609
    14 Catawba Clinical Research Tampa Florida United States 33618
    15 Catawba Clinical Research Savannah Georgia United States 31406
    16 Catawba Clinical Research New Orleans Louisiana United States 70130
    17 Catawba Clinical Research Norfolk Nebraska United States 68701
    18 Catawba Clinical Research Omaha Nebraska United States 68134
    19 Catawba Clinical Research Las Vegas Nevada United States 89106
    20 Catawba Clinical Research Las Vegas Nevada United States 89109
    21 Catawba Clinical Research Las Vegas Nevada United States 89119
    22 Catawba Clinical Research Endwell New York United States 13760
    23 Catawba Clinical Research New York New York United States 10012
    24 Catawba Clinical Research High Point North Carolina United States 27262
    25 Catawba Clinical Research Wilmington North Carolina United States 28405
    26 Catawba Clinical Research Cincinnati Ohio United States 45246
    27 Catawba Clinical Research Jenkintown Pennsylvania United States 19046
    28 Catawba Clinical Research Upper St Clair Pennsylvania United States 15241
    29 Catawba Clinical Research Warminster Pennsylvania United States 18974
    30 Catawba Clinical Research Nashville Tennessee United States 37215
    31 Catawba Clinical Research Austin Texas United States 78746
    32 Catawba Clinical Research El Paso Texas United States 79902
    33 Catawba Clinical Research Mesquite Texas United States 75149
    34 Catawba Clinical Research Norfolk Virginia United States 23507
    35 Catawba Clinical Research Richland Washington United States 97030
    36 Catawba Clinical Research Belize City Belize

    Sponsors and Collaborators

    • Seegpharm S.A.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seegpharm S.A.
    ClinicalTrials.gov Identifier:
    NCT02865005
    Other Study ID Numbers:
    • SEEG-2015-6-23
    First Posted:
    Aug 12, 2016
    Last Update Posted:
    Dec 20, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Dapsone

    Study Results

    No Results Posted as of Dec 20, 2016