- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974141
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
October 5, 2018 updated by: Almirall, S.A.
A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris
This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.
Study Type
Interventional
Enrollment (Actual)
2102
Phase
- 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
-
-
Ontario
-
North Bay, Ontario, Canada
-
-
-
-
California
-
Encino, California, United States
-
-
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
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of acne vulgaris
- Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study
Exclusion Criteria:
- Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
- Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
- Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
- Use of birth control pills strictly for acne control
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dapsone Gel
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Placebo Comparator: Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
Time Frame: Week 12
|
The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe.
The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.
|
Week 12
|
Change From Baseline in Inflammatory Facial Lesion Counts
Time Frame: Baseline, Week 12
|
The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst).
A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
|
Baseline, Week 12
|
Change From Baseline in Noninflammatory Facial Lesion Counts
Time Frame: Baseline, Week 12
|
The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst).
A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
|
Baseline, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Lesion Counts
Time Frame: Baseline, Week 12
|
The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions.
A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth.
The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts.
A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
|
Baseline, Week 12
|
Percentage Change From Baseline in Total Lesion Counts
Time Frame: Baseline, Week 12
|
The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions.
A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth.
The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts.
A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).
|
Baseline, Week 12
|
Percentage of Patients Reporting "Very Good" or "Excellent" on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)
Time Frame: Week 12
|
The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS.
Item 10 scores range from 1 (Excellent) to 5 (Bad).
The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported "Very good" or "Excellent" at Week 12 are reported.
|
Week 12
|
Change From Baseline in the 9-Item ASIS Sign Domain Score
Time Frame: Baseline, Week 12
|
The patient assessed signs of acne vulgaris using the ASIS.
The sign domain is a composite of 9 items of the 17 items on the overall scale.
Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst).
The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
|
Baseline, Week 12
|
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale
Time Frame: Baseline, Week 12
|
The patient assessed their facial oiliness using item 1 on the 5-point ASIS.
Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily).
The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.
|
Baseline, Week 12
|
Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale
Time Frame: Baseline, Week 12
|
The patient assessed their facial redness using item 8 on the 5-point ASIS.
Item 8 scores ranged from 0 (Not at all red) to 4 (Very red).
The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.
|
Baseline, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
- Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
- Tanghetti E, Harper J, Baldwin H, Kircik L, Bai Z, Alvandi N. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females. J Drugs Dermatol. 2018 Nov 1;17(11):1192-1198.
- Thiboutot DM, Kircik L, McMichael A, Cook-Bolden FE, Tyring SK, Berk DR, Chang-Lin JE, Lin V, Kaoukhov A. Efficacy, Safety, and Dermal Tolerability of Dapsone Gel, 7.5% in Patients with Moderate Acne Vulgaris: A Pooled Analysis of Two Phase 3 Trials. J Clin Aesthet Dermatol. 2016 Oct;9(10):18-27. Epub 2016 Oct 1.
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
November 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 1, 2013
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 225678-006
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.
Clinical Trials on Acne Vulgaris
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on Dapsone Gel
-
Torrent Pharmaceuticals LimitedCatawba ResearchCompletedAcne VulgarisUnited States, Belize
-
Almirall, S.A.AllerganCompleted
-
Almirall, S.A.AllerganCompleted
-
Almirall, S.A.AllerganCompletedAcne VulgarisUnited States, Canada
-
AllerganCompletedRosaceaUnited States
-
Vanderbilt University Medical CenterTerminated
-
AllerganCompleted
-
Almirall, S.A.AllerganCompleted
-
AllerganWithdrawn
-
Seegpharm S.A.Completed