Clinical trial NCT02865005: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Seegpharm S.A.
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 2361
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
timeFrame: Treatment Days: 84 days of dosing
Secondary outcomes:
measure: Clinical Success: Proportion of subjects with a clinical response of "success"
timeFrame: 12 Weeks
Other outcomes:
measure: Safety Outcomes: Incidence of Adverse Events
timeFrame: Baseline (Day 1) to Week 12 (Day 85)
measure: Safety Outcomes: Change in Vital Signs
timeFrame: Baseline (Day 1) to Week 12 (Day 85)
measure: Safety Outcomes: Local Skin/Application Site Reaction Scores
timeFrame: Baseline (Day 1) to Week 12 (Day 85)
Locations:
city: Encino
country: United States
facility: Catawba Clinical Research
state: California
city: Fullerton
country: United States
facility: Catawba Clinical Research
state: California
city: La Mesa
country: United States
facility: Catawba Clinical Research
state: California
city: Los Angeles
country: United States
facility: Catawba Clinical Research
state: California
city: Los Angeles
country: United States
facility: Catawba Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Catawba Clinical Research
state: California
city: Temecula
country: United States
facility: Catawba Clinical Research
state: California
city: Boca Raton
country: United States
facility: Catawba Clinical Research
state: Florida
city: Brandon
country: United States
facility: Catawba Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Catawba Clinical Research
state: Florida
city: Miami
country: United States
facility: Catawba Clinical Research
state: Florida
city: Miramar
country: United States
facility: Catawba Clinical Research
state: Florida
city: S Tampa
country: United States
facility: Catawba Clinical Research
state: Florida
city: Tampa
country: United States
facility: Catawba Clinical Research
state: Florida
city: Savannah
country: United States
facility: Catawba Clinical Research
state: Georgia
city: New Orleans
country: United States
facility: Catawba Clinical Research
state: Louisiana
city: Norfolk
country: United States
facility: Catawba Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Catawba Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Catawba Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Catawba Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Catawba Clinical Research
state: Nevada
city: Endwell
country: United States
facility: Catawba Clinical Research
state: New York
city: New York
country: United States
facility: Catawba Clinical Research
state: New York
city: High Point
country: United States
facility: Catawba Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: Catawba Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Catawba Clinical Research
state: Ohio
city: Jenkintown
country: United States
facility: Catawba Clinical Research
state: Pennsylvania
city: Upper St Clair
country: United States
facility: Catawba Clinical Research
state: Pennsylvania
city: Warminster
country: United States
facility: Catawba Clinical Research
state: Pennsylvania
city: Nashville
country: United States
facility: Catawba Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Catawba Clinical Research
state: Texas
city: El Paso
country: United States
facility: Catawba Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Catawba Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Catawba Clinical Research
state: Virginia
city: Richland
country: United States
facility: Catawba Clinical Research
state: Washington
city: Belize City
country: Belize
facility: Catawba Clinical Research
Study officials:
affiliation: Catawba Clinical Research
name: Karen Lewis, MS
role: STUDY_DIRECTOR
References: