Study Stopped
Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 25, 2013
February 1, 2013
7 months
February 5, 2013
February 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Inflammatory Lesion Count
Baseline, Week 12
Secondary Outcomes (3)
Change from Baseline in Non-Inflammatory Lesion Count
Baseline, Week 12
Change from Baseline in Total Lesion Count
Baseline, Week 12
Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
Week 12
Study Arms (4)
Dapsone Formulation A
EXPERIMENTALDapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation B
EXPERIMENTALDapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation C
EXPERIMENTALDapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone 5% Gel
ACTIVE COMPARATORDapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Interventions
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 applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
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 (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Eligibility Criteria
You may qualify if:
- Participation in Allergan study 225678-004
You may not qualify if:
- Anticipates the need for surgery or hospitalization during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
March 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 25, 2013
Record last verified: 2013-02