A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032407
• Other study ID #: GMA-ACZ-13-001
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: August 11, 2015
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Dapsone Gel
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician	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.	Baseline, Week 12	No
Secondary	Change From Baseline in the GAAS	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.	Baseline, Weeks 2 and 6	No
Secondary	Percent Change From Baseline in Total Lesion Counts	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).	Baseline, Weeks 2, 6 and 12	No
Secondary	Percent Change From Baseline in Inflammatory Lesion Counts	The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).	Baseline, Weeks 2, 6 and 12	No
Secondary	Percent Change From Baseline in Non-Inflammatory Lesion Counts	The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).	Baseline, Weeks 2, 6 and 12	No
Secondary	Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS	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.	Weeks 2, 6 and 12	No
Secondary	Acne Symptom and Impact Scale (ASIS) Sign Domain Score	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.	Weeks 2, 6 and 12	No
Secondary	ASIS Impact Domain Score	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.	Weeks 2, 6 and 12	No