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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborator: Mundipharma Pte Ltd.
• Treatments: Iodine; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

1. Patients diagnosed with mild to moderate inflammatory acne - grade 2 to 3.

2. Patients must be at least 12 years of age

3. No gender preference - both male and female allowed

4. Subjects who provide signed and dated written voluntary informed consent

Exclusion Criteria:

1. Thyroid Dysfunction

2. Pregnancy, Breast feeding

3. History of hypersensitivity to iodine

4. History of renal impairment

5. Using OCPs

6. Using concurrent medications known to exacerbate acne

7. Nodulocystic acne or other severe variants

8. Had a facial procedure - chemical or laser peel or microdermabrasion 2 weeks before the study

9. No topical antiacne products 2 weeks prior to study commencement till its conclusion.

10. No systemic corticosteroids 4 weeks prior to study start

11. No systemic retinoids 3 months prior to study start

12. No concurrent use of tanning booths or sunbathing

13. Any condition in the judgement of the investigator that may place the person at unacceptable risk for participation

14. Any subject who participated in another clinical trial with 30 days of study entry,