The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
NCT ID: NCT02126709
Last Updated: 2014-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2014-06-30
2014-12-31
Brief Summary
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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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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment Arm
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
Repigel
Repigel will be used as the intervention in the treatment group
Placebo Arm
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
No interventions assigned to this group
Interventions
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Repigel
Repigel will be used as the intervention in the treatment group
Eligibility Criteria
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Inclusion Criteria
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
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,
13 Years
60 Years
ALL
No
Sponsors
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Mundipharma Pte Ltd.
INDUSTRY
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Sam SY Yang, MBBS
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Facility Contacts
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Sam Yang, Dr
Role: primary
Other Identifiers
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2013/01233
Identifier Type: -
Identifier Source: org_study_id