NCT02126709

The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy

Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 13 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Importance This will be a proof of concept study - whereby we hypothesize that Repigel may represent a paradigm shift in global acne treatment. Historically, there has been a dearth of clinical evidence in this use of povidone-iodine for inflammatory acne. This is likely due to staining related to iodine use, which is not acceptable to consumers. The trial drug, Povidone Iodine, however, becomes colourless and odourless in a matter of seconds after application on the skin. This represents an ideal product for which we may perform testing to look at its efficacy in the management of acne. A mainstay in the pathogenesis of acne involves the overgrowth and proliferation of skin micro-organisms, primarily proprionibacterium Acnes. Long term antibiotic therapy is usually prescribed for a period of 3 to 6 months or more. Previous studies have revealed this form of antibiotic therapy is ineffective, patients are usually poorly compliant, and also results in the formation of antibiotic resistant micro-organisms,which in turn reduces treatment efficacy. Potential Benefits As such, Povidone Iodine with its antiseptic property represents a promising avenue for the elimination of Proprionibacterium Acnes without the associated problems of long term antibiotic use, and the development of antibiotic-resistance. It is cosmetically acceptable, affordable, and easy to use.

Detailed description

Aim This is a proof of concept study - to determine the efficacy and safety of Povidone Iodine in the treatment of acne. Methodology This will be a single centre, double blind, randomized controlled trial. There will be 2 arms of 15 patients with a 2 month study period. Follow up at Week 0, Week 2, Week 4, Week 6, Week 8 3\. Capture baseline demographics a. Age b. Sex c. Race d. Lesion counts - total, inflammatory, non-inflammatory e. FDA score 4\. Efficacy evaluation a. 5 point IGA score b. Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions e. Photography (+-) f. Scoring of the Cardiff Acne Disability Index. 5\. Safety Evaluation a. Score of itchiness b. Score of scaling c. Score of erythema d. Score of pain 6\. Primary end points - a. percentage reduction in lesion counts from week 0 to week 8 i. total lesion counts ii. total inflammatory counts iii. total non-inflammatory counts b. Proportion of subjects who had a IGA score of 0 or 1 by week 8 c. Time to 50% reduction of total lesion counts 7\. Secondary end point a. Improvement of the Cardiff Acne Disability Index Povidone Iodine will be applied on the face by the patient using his own finger tips - onto his acne affected areas on the face.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Repigel	Repigel will be used as the intervention in the treatment group

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-04-30
• Last updated: 2014-04-30

Locations

1 site across 1 country: Singapore