Randomized, phase 2, dose-ranging study in the treatment of rosacea with encapsulated benzoyl peroxide gel.

Abstract

OBJECTIVE:

Compare the safety and efficacy of 1% and 5% silica encapsulated benzoyl peroxide (E-BPO) in patients with papulopustular rosacea.

DESIGN:

Multi-centered randomized, double blind, vehicle controlled parallel group, 12 week treatment in 92 patients with papulopustular rosacea. Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions.

PATIENTS:

92 patients: 74% graded as moderate IGA, 14% severe and 12% mild. The mean inflammatory lesion count was 24.

INTERVENTION:

Once daily treatment for 12 weeks with vehicle, 1% or 5% E-BPO.

RESULTS:

1% and 5% E-BPO were superior to vehicle in reducing papulopustular lesions P =0.01 and P =0.02. 5% E-BPO was superior to vehicle for IGA P =0.0013.

• Authors: James J Leyden
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 13 Issue 6 Pg. 685-8 (Jun 2014) ISSN: 1545-9616 [Print] United States
• PMID: 24918558 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Dermatologic Agents
• Gels
• Silicon Dioxide
• Benzoyl Peroxide

Topics

• Administration, Cutaneous
• Adult
• Aged
• Aged, 80 and over
• Benzoyl Peroxide (administration & dosage, adverse effects, therapeutic use)
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Gels
• Humans
• Male
• Middle Aged
• Rosacea (drug therapy, pathology)
• Severity of Illness Index
• Silicon Dioxide (chemistry)
• Treatment Outcome