Phase 1 Completed N=77 Randomized Double-blind Basic Science

Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Source: ClinicalTrials.gov NCT01773122 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcomePrimary: Maximum Plasma Level (Cmax) of Dapsone — 11.7; 14.1; 13.0; 17.6 Nanograms/Milliliter (ng/mL)

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Level (Cmax) of Dapsone	11.7; 14.1; 13.0; 17.6	—
SECONDARY Maximum Plasma Level (Cmax) of Dapsone Metabolites	5.44; 6.00; 6.47; 11.7; 0.908; 1.11	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of acne vulgaris
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

Oral acne treatments within 6 months

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Data sourced from ClinicalTrials.gov (NCT01773122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.