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A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

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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.

Study Description
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Brief Summary:
This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Dapsone Gel Drug: Dapsone Gel Vehicle Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arms and Interventions
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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.
 Drug: Dapsone Gel
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.
 Drug: Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01974141


Locations
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United States, California
Encino, California, United States
Canada, Ontario
North Bay, Ontario, Canada
Sponsors and Collaborators
Almirall, S.A.
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01974141     History of Changes
Other Study ID Numbers: 225678-006
First Posted: November 1, 2013    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: October 8, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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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