An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01785836
• Other study ID #: 225678-005
• Status: Withdrawn
• Phase: Phase 1
• First received: February 5, 2013
• Last updated: February 22, 2013
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: February 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

• Participation in Allergan study 225678-004

Exclusion Criteria:

• Anticipates the need for surgery or hospitalization during the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Dapsone Formulation A
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
• Dapsone Formulation B
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
• Dapsone Formulation C
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
• Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Inflammatory Lesion Count		Baseline, Week 12	No
Secondary	Change from Baseline in Non-Inflammatory Lesion Count		Baseline, Week 12	No
Secondary	Change from Baseline in Total Lesion Count		Baseline, Week 12	No
Secondary	Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1		Week 12	No