ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Dapsone Gel in Females With Skin of Color and 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: NCT02032407
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Dapsone Gel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: Dapsone Gel
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Drug: Dapsone Gel
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Other Name: Aczone®




Primary Outcome Measures :
  1. Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician [ Time Frame: Baseline, Week 12 ]
    The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.


Secondary Outcome Measures :
  1. Change From Baseline in the GAAS [ Time Frame: Baseline, Weeks 2 and 6 ]
    The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.

  2. Percent Change From Baseline in Total Lesion Counts [ Time Frame: Baseline, Weeks 2, 6 and 12 ]
    The investigator evaluated 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).

  3. Percent Change From Baseline in Inflammatory Lesion Counts [ Time Frame: Baseline, Weeks 2, 6 and 12 ]
    The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).

  4. Percent Change From Baseline in Non-Inflammatory Lesion Counts [ Time Frame: Baseline, Weeks 2, 6 and 12 ]
    The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).

  5. Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS [ Time Frame: Weeks 2, 6 and 12 ]
    The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.

  6. Acne Symptom and Impact Scale (ASIS) Sign Domain Score [ Time Frame: Weeks 2, 6 and 12 ]
    The participant 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 answered 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. Higher scores indicate the presence of more severe signs of acne.

  7. ASIS Impact Domain Score [ Time Frame: Weeks 2, 6 and 12 ]
    The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.



Information from the National Library of Medicine

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acne vulgaris
  • Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
  • Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

  • Received treatment with botulinum toxin of any serotype in the face within 6 months

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): NCT02032407


Locations
United States, District of Columbia
Washington, District of Columbia, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02032407     History of Changes
Other Study ID Numbers: GMA-ACZ-13-001
First Posted: January 10, 2014    Key Record Dates
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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