The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
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|ClinicalTrials.gov Identifier: NCT02126709|
Recruitment Status : Unknown
Verified April 2014 by National University Hospital, Singapore.
Recruitment status was: Not yet recruiting
First Posted : April 30, 2014
Last Update Posted : April 30, 2014
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne||Drug: Repigel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: 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
Repigel will be used as the intervention in the treatment group
Placebo Comparator: 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
- 5 point Acne Score [ Time Frame: 2 months ]
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.
- Lesional Counts [ Time Frame: 2 months ]b. Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions
- Effect on Quality of Life [ Time Frame: 2 months ]Scoring of the Cardiff Acne Disability Index.
- Safety [ Time Frame: 2 months ]
- Score of itchiness
- Score of scaling
- Score of erythema
- Score of pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126709
|Contact: Sam SY Yang, Dremail@example.com|
|National University Hospital||Not yet recruiting|
|Singapore, Singapore, 119074|
|Contact: Sam Yang, Dr 85333992 firstname.lastname@example.org|
|Principal Investigator:||Sam SY Yang, MBBS||National University Hospital, Singapore|