Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
NCT ID: NCT01773122
Last Updated: 2019-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
77 participants
INTERVENTIONAL
2013-01-21
2013-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Interventions
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Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
* If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
* willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study
Exclusion Criteria
16 Years
35 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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College Station, Texas, United States
Countries
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References
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Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259.
Other Identifiers
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225678-004
Identifier Type: -
Identifier Source: org_study_id
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