The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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
|
Drug: Repigel
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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,
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, Dr | 85333992 | samsyyang@gmail.com |
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 | |
Contact: Sam Yang, Dr 85333992 samsyyang@gmail.com |
Principal Investigator: | Sam SY Yang, MBBS | National University Hospital, Singapore |
Responsible Party: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT02126709 |
Other Study ID Numbers: |
2013/01233 |
First Posted: | April 30, 2014 Key Record Dates |
Last Update Posted: | April 30, 2014 |
Last Verified: | April 2014 |
Povidone Iodine Safety Efficacy Acne treatment |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |