Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02865005 |
Recruitment Status :
Completed
First Posted : August 12, 2016
Last Update Posted : December 20, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: Dapsone 5.0% Gel (SEEGPharm) Other: Placebo Drug: Dapsone 5.0% Gel (Allergan) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | February 2016 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | December 2016 |

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 Name: 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 Name: Experimental Arm |
Placebo Comparator: Placebo
Vehicle of Experimental Gel applied twice daily for 84 days
|
Other: Placebo
Topical Gel
Other Name: Placebo Comparator |
- 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)
- 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.
- 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)
- 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)
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 40 Years (Child, Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865005
United States, California | |
Catawba Clinical Research | |
Encino, California, United States, 91436 | |
Catawba Clinical Research | |
Fullerton, California, United States, 92835 | |
Catawba Clinical Research | |
La Mesa, California, United States, 91942 | |
Catawba Clinical Research | |
Los Angeles, California, United States, 90017 | |
Catawba Clinical Research | |
Los Angeles, California, United States, 90036 | |
Catawba Clinical Research | |
Sherman Oaks, California, United States, 91403 | |
Catawba Clinical Research | |
Temecula, California, United States, 92592 | |
United States, Florida | |
Catawba Clinical Research | |
Boca Raton, Florida, United States, 33486 | |
Catawba Clinical Research | |
Brandon, Florida, United States, 33511 | |
Catawba Clinical Research | |
Hialeah, Florida, United States, 33016 | |
Catawba Clinical Research | |
Miami, Florida, United States, 33175 | |
Catawba Clinical Research | |
Miramar, Florida, United States, 33027 | |
Catawba Clinical Research | |
S Tampa, Florida, United States, 33609 | |
Catawba Clinical Research | |
Tampa, Florida, United States, 33618 | |
United States, Georgia | |
Catawba Clinical Research | |
Savannah, Georgia, United States, 31406 | |
United States, Louisiana | |
Catawba Clinical Research | |
New Orleans, Louisiana, United States, 70130 | |
United States, Nebraska | |
Catawba Clinical Research | |
Norfolk, Nebraska, United States, 68701 | |
Catawba Clinical Research | |
Omaha, Nebraska, United States, 68134 | |
United States, Nevada | |
Catawba Clinical Research | |
Las Vegas, Nevada, United States, 89106 | |
Catawba Clinical Research | |
Las Vegas, Nevada, United States, 89109 | |
Catawba Clinical Research | |
Las Vegas, Nevada, United States, 89119 | |
United States, New York | |
Catawba Clinical Research | |
Endwell, New York, United States, 13760 | |
Catawba Clinical Research | |
New York, New York, United States, 10012 | |
United States, North Carolina | |
Catawba Clinical Research | |
High Point, North Carolina, United States, 27262 | |
Catawba Clinical Research | |
Wilmington, North Carolina, United States, 28405 | |
United States, Ohio | |
Catawba Clinical Research | |
Cincinnati, Ohio, United States, 45246 | |
United States, Pennsylvania | |
Catawba Clinical Research | |
Jenkintown, Pennsylvania, United States, 19046 | |
Catawba Clinical Research | |
Upper St Clair, Pennsylvania, United States, 15241 | |
Catawba Clinical Research | |
Warminster, Pennsylvania, United States, 18974 | |
United States, Tennessee | |
Catawba Clinical Research | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
Catawba Clinical Research | |
Austin, Texas, United States, 78746 | |
Catawba Clinical Research | |
El Paso, Texas, United States, 79902 | |
Catawba Clinical Research | |
Mesquite, Texas, United States, 75149 | |
United States, Virginia | |
Catawba Clinical Research | |
Norfolk, Virginia, United States, 23507 | |
United States, Washington | |
Catawba Clinical Research | |
Richland, Washington, United States, 97030 | |
Belize | |
Catawba Clinical Research | |
Belize City, Belize |
Study Director: | Karen Lewis, MS | Catawba Clinical Research |
Responsible Party: | Seegpharm S.A. |
ClinicalTrials.gov Identifier: | NCT02865005 |
Other Study ID Numbers: |
SEEG-2015-6-23 |
First Posted: | August 12, 2016 Key Record Dates |
Last Update Posted: | December 20, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Dapsone Anti-Infective Agents Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |