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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne

Intervention / Treatment
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* Drug: Repigel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with mild to moderate inflammatory acne - grade 2 to 3. Patients must be at least 12 years of age No gender preference - both male and female allowed Subjects who provide signed and dated written voluntary informed consent Exclusion Criteria: Thyroid Dysfunction Pregnancy, Breast feeding History of hypersensitivity to iodine History of renal impairment Using OCPs Using concurrent medications known to exacerbate acne Nodulocystic acne or other severe variants Had a facial procedure - chemical or laser peel or microdermabrasion 2 weeks before the study No topical antiacne products 2 weeks prior to study commencement till its conclusion. No systemic corticosteroids 4 weeks prior to study start No systemic retinoids 3 months prior to study start No concurrent use of tanning booths or sunbathing Any condition in the judgement of the investigator that may place the person at unacceptable risk for participation Any subject who participated in another clinical trial with 30 days of study entry,

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Name: Repigel Active ingredient: Povidone iodine Dosage form: Liposomal hydrogel Administration route: Topical Strength: 3% Application of study cream twice a day during the 8 week study period It will be applied once in the morning and once in the night We recommend the application to occur after the face is washed One Finger Tip Unit is required per application to the entire face The gel should be left on and not washed of for at least15 -30 minutes | Drug: Repigel<br>* Repigel will be used as the intervention in the treatment group<br>|
| Placebo Comparator: Placebo Arm<br>Name: Neutrogena hydroboost gel Active ingredient: NA Strength: NA Dosage form: Water gel Administration route: Topical Application of placebo cream twice a day during the 8 week study period It will be applied once in the morning and once in the night We recommend the application to occur after the face is washed One Finger Tip Unit is required per application to the entire face The gel should be left on and not washed of for at least15 -30 minutes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Lesional Counts | b. Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions | 2 months | 
| Effect on Quality of Life | Scoring of the Cardiff Acne Disability Index. | 2 months | 
| Safety | Score of itchiness Score of scaling Score of erythema Score of pain | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Povidone Iodine, Safety, Efficacy, Acne treatment