Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
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
1 other identifier
interventional
2,361
2 countries
36
Brief Summary
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2016
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 20, 2016
December 1, 2016
9 months
July 1, 2016
December 19, 2016
Conditions
Outcome Measures
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
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)
Treatment Days: 84 days of dosing
Secondary Outcomes (1)
Clinical Success: Proportion of subjects with a clinical response of "success"
12 Weeks
Other Outcomes (3)
Safety Outcomes: Incidence of Adverse Events
Baseline (Day 1) to Week 12 (Day 85)
Safety Outcomes: Change in Vital Signs
Baseline (Day 1) to Week 12 (Day 85)
Safety Outcomes: Local Skin/Application Site Reaction Scores
Baseline (Day 1) to Week 12 (Day 85)
Study Arms (3)
Dapsone 5.0% Gel (Allergan)
ACTIVE COMPARATORDapsone 5.0% Gel applied twice daily for 84 days
Dapsone 5.0% Gel (SEEGPharm)
EXPERIMENTALDapsone 5.0% Gel applied twice daily for 84 days
Placebo
PLACEBO COMPARATORVehicle of Experimental Gel applied twice daily for 84 days
Interventions
Topical Gel
Topical Gel
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seegpharm S.A.lead
Study Sites (36)
Catawba Clinical Research
Encino, California, 91436, United States
Catawba Clinical Research
Fullerton, California, 92835, United States
Catawba Clinical Research
La Mesa, California, 91942, United States
Catawba Clinical Research
Los Angeles, California, 90017, United States
Catawba Clinical Research
Los Angeles, California, 90036, United States
Catawba Clinical Research
Sherman Oaks, California, 91403, United States
Catawba Clinical Research
Temecula, California, 92592, United States
Catawba Clinical Research
Boca Raton, Florida, 33486, United States
Catawba Clinical Research
Brandon, Florida, 33511, United States
Catawba Clinical Research
Hialeah, Florida, 33016, United States
Catawba Clinical Research
Miami, Florida, 33175, United States
Catawba Clinical Research
Miramar, Florida, 33027, United States
Catawba Clinical Research
South Tampa, Florida, 33609, United States
Catawba Clinical Research
Tampa, Florida, 33618, United States
Catawba Clinical Research
Savannah, Georgia, 31406, United States
Catawba Clinical Research
New Orleans, Louisiana, 70130, United States
Catawba Clinical Research
Norfolk, Nebraska, 68701, United States
Catawba Clinical Research
Omaha, Nebraska, 68134, United States
Catawba Clinical Research
Las Vegas, Nevada, 89106, United States
Catawba Clinical Research
Las Vegas, Nevada, 89109, United States
Catawba Clinical Research
Las Vegas, Nevada, 89119, United States
Catawba Clinical Research
Endwell, New York, 13760, United States
Catawba Clinical Research
New York, New York, 10012, United States
Catawba Clinical Research
High Point, North Carolina, 27262, United States
Catawba Clinical Research
Wilmington, North Carolina, 28405, United States
Catawba Clinical Research
Cincinnati, Ohio, 45246, United States
Catawba Clinical Research
Jenkintown, Pennsylvania, 19046, United States
Catawba Clinical Research
Upper Saint Clair, Pennsylvania, 15241, United States
Catawba Clinical Research
Warminster, Pennsylvania, 18974, United States
Catawba Clinical Research
Nashville, Tennessee, 37215, United States
Catawba Clinical Research
Austin, Texas, 78746, United States
Catawba Clinical Research
El Paso, Texas, 79902, United States
Catawba Clinical Research
Mesquite, Texas, 75149, United States
Catawba Clinical Research
Norfolk, Virginia, 23507, United States
Catawba Clinical Research
Richland, Washington, 97030, United States
Catawba Clinical Research
Belize City, Belize
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karen Lewis, MS
Catawba Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2016
First Posted
August 12, 2016
Study Start
February 1, 2016
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
December 20, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share