Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety and Efficacy Study of Dapsone Gel in Patients With 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: NCT01974141
Recruitment Status : Completed
First Posted : November 1, 2013
Results First Posted : February 6, 2017
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 1, 2013
Results First Submitted Date  ICMJE April 7, 2016
Results First Posted Date  ICMJE February 6, 2017
Last Update Posted Date October 8, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2016)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Percentage of Patients with None or Minimal on the 5-Point Global Acne Assessment Score (GAAS) Scale [ Time Frame: Week 12 ]
  • Change From Baseline in Inflammatory Facial Lesion Counts [ Time Frame: Baseline, Week 12 ]
  • Change From Baseline in Noninflammatory Facial Lesion Counts [ Time Frame: Baseline, Week 12 ]
Change History Complete list of historical versions of study NCT01974141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2016)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Change From Baseline in Total Lesion Counts [ Time Frame: Baseline, Week 12 ]
  • Percentage Change from Baseline in Lesion Counts [ Time Frame: Baseline, Week 12 ]
  • Percentage of Patients Reporting "Very Good" or "Excellent" in the Assessment of Facial Appearance on a 5-Point Scale [ Time Frame: Week 12 ]
  • Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Oiliness on a 5-Point Scale [ Time Frame: Baseline, Week 12 ]
  • Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Redness on a 5-Point Scale [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in the 9-Item Acne Symptom and Impact Scale (ASIS) Symptom Domain Total Score [ Time Frame: Baseline, Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris
Official Title  ICMJE A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris
Brief Summary This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Dapsone Gel
    Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
  • Drug: Dapsone Gel Vehicle
    Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Study Arms  ICMJE
  • Experimental: Dapsone Gel
    Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
    Intervention: Drug: Dapsone Gel
  • 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.
    Intervention: Drug: Dapsone Gel Vehicle
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2016)
2102
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
2180
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01974141
Other Study ID Numbers  ICMJE 225678-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Almirall, S.A.
Study Sponsor  ICMJE Almirall, S.A.
Collaborators  ICMJE Allergan
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Almirall, S.A.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP