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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02126709
• Other study ID #: 2013/01233
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 28, 2014
• Last updated: April 29, 2014
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Sam SY Yang, Dr
• Phone: 85333992
• Email: samsyyang[@]gmail.com
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 60 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Repigel
Repigel will be used as the intervention in the treatment group

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Mundipharma Pte Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 point Acne Score	0 Clear, indicating no inflammatory or noninflammatory lesions; Almost clear, rare noninflammatory lesions with no more than one papules/pustule; Mild, some noninflammatory lesions, no more than a few papules/pustules but no nodules; Moderate, up to many noninflammatory lesions, may have some inflammatory lesions, but no more than one small nodule; Severe, up to many noninflammatory and inflammatory lesions, but no more than a few nodules.	2 months	No
Primary	Lesional Counts	b. Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions	2 months	No
Primary	Effect on Quality of Life	Scoring of the Cardiff Acne Disability Index.	2 months	No
Primary	Safety	Score of itchiness; Score of scaling; Score of erythema; Score of pain	2 months	Yes