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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapsone 5.0% Gel (SEEGPharm)
Placebo
Dapsone 5.0% Gel (Allergan)
Sponsored by
Seegpharm S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research
  • Catawba Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Dapsone 5.0% Gel (Allergan)

Dapsone 5.0% Gel (SEEGPharm)

Placebo

Arm Description

Dapsone 5.0% Gel applied twice daily for 84 days

Dapsone 5.0% Gel applied twice daily for 84 days

Vehicle of Experimental Gel applied twice daily for 84 days

Outcomes

Primary Outcome Measures

Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
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

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

Full Information

First Posted
July 1, 2016
Last Updated
December 19, 2016
Sponsor
Seegpharm S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02865005
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seegpharm S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapsone 5.0% Gel (Allergan)
Arm Type
Active Comparator
Arm Description
Dapsone 5.0% Gel applied twice daily for 84 days
Arm Title
Dapsone 5.0% Gel (SEEGPharm)
Arm Type
Experimental
Arm Description
Dapsone 5.0% Gel applied twice daily for 84 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle of Experimental Gel applied twice daily for 84 days
Intervention Type
Drug
Intervention Name(s)
Dapsone 5.0% Gel (SEEGPharm)
Other Intervention Name(s)
Experimental Arm
Intervention Description
Topical Gel
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Topical Gel
Intervention Type
Drug
Intervention Name(s)
Dapsone 5.0% Gel (Allergan)
Other Intervention Name(s)
Active Comparator
Intervention Description
Topical Gel
Primary Outcome Measure Information:
Title
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
Description
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)
Time Frame
Treatment Days: 84 days of dosing
Secondary Outcome Measure Information:
Title
Clinical Success: Proportion of subjects with a clinical response of "success"
Description
To evaluate as the proportion of subjects with a clinical response of "success" at Week 12.
Time Frame
12 Weeks
Other Pre-specified Outcome Measures:
Title
Safety Outcomes: Incidence of Adverse Events
Description
Analysis of the incidence of Adverse Events from Baseline (Day 1) to Week 12 (Day 85)
Time Frame
Baseline (Day 1) to Week 12 (Day 85)
Title
Safety Outcomes: Change in Vital Signs
Description
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)
Time Frame
Baseline (Day 1) to Week 12 (Day 85)
Title
Safety Outcomes: Local Skin/Application Site Reaction Scores
Description
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.
Time Frame
Baseline (Day 1) to Week 12 (Day 85)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Lewis, MS
Organizational Affiliation
Catawba Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Catawba Clinical Research
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Catawba Clinical Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Catawba Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Catawba Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Catawba Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Catawba Clinical Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Catawba Clinical Research
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Catawba Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Catawba Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Catawba Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Catawba Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Catawba Clinical Research
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Catawba Clinical Research
City
S Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Catawba Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Catawba Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Catawba Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States
Facility Name
Catawba Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Catawba Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Catawba Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Catawba Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Catawba Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Catawba Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Catawba Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Catawba Clinical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Catawba Clinical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Catawba Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Catawba Clinical Research
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Catawba Clinical Research
City
Upper St Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Catawba Clinical Research
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
Catawba Clinical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Catawba Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Catawba Clinical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Catawba Clinical Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Catawba Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Catawba Clinical Research
City
Richland
State/Province
Washington
ZIP/Postal Code
97030
Country
United States
Facility Name
Catawba Clinical Research
City
Belize City
Country
Belize

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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