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Completed

NCT Number: NCT02865005

Trial of Dapsone 5.0% Gel 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catawba Clinical Research, Belize City, Belize

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dapsone 5.0% Gel (SEEGPharm)

Drug

Topical Gel

Other names: Experimental Arm

Placebo

Other

Topical Gel

Other names: Placebo Comparator

Dapsone 5.0% Gel (Allergan)

Drug

Topical Gel

Other names: Active Comparator

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seegpharm S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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