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

December 19, 2016 updated by: Seegpharm S.A.

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

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2361

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belize
      • Belize City, Belize
        • Catawba Clinical Research
  • United States
    • California
      • 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
        • Catawba Clinical Research
    • Florida
      • 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
        • Catawba Clinical Research
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Catawba Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70130
        • Catawba Clinical Research
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Catawba Clinical Research
      • Omaha, Nebraska, United States, 68134
        • Catawba Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Catawba Clinical Research
      • Las Vegas, Nevada, United States, 89109
        • Catawba Clinical Research
      • Las Vegas, Nevada, United States, 89119
        • Catawba Clinical Research
    • New York
      • Endwell, New York, United States, 13760
        • Catawba Clinical Research
      • New York, New York, United States, 10012
        • Catawba Clinical Research
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Catawba Clinical Research
      • Wilmington, North Carolina, United States, 28405
        • Catawba Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Catawba Clinical Research
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Catawba Clinical Research
      • Upper St Clair, Pennsylvania, United States, 15241
        • Catawba Clinical Research
      • Warminster, Pennsylvania, United States, 18974
        • Catawba Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Catawba Clinical Research
    • Texas
      • Austin, Texas, United States, 78746
        • Catawba Clinical Research
      • El Paso, Texas, United States, 79902
        • Catawba Clinical Research
      • Mesquite, Texas, United States, 75149
        • Catawba Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Catawba Clinical Research
    • Washington
      • Richland, Washington, United States, 97030
        • Catawba Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Experimental Arm
Placebo Comparator: Placebo
Vehicle of Experimental Gel applied twice daily for 84 days
Other: Placebo
Topical Gel
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Treatment Days: 84 days of dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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.
Baseline (Day 1) to Week 12 (Day 85)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seegpharm S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karen Lewis, MS, Catawba Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEEG-2015-6-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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