Acne | The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
Acne research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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,
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RepigelRepigel will be used as the intervention in the treatment group
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Treatment ArmName: 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
Placebo ArmName: 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
Start Date: June 2014
Completed Date: December 2014
Phase: Phase 2
Primary Outcome: 5 point Acne Score
Study sponsors, principal investigator, and references
Principal Investigator: Sam SY Yang, MBBS
Lead Sponsor: National University Hospital, Singapore
Collaborator: Mundipharma Pte Ltd.