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

NCT02126709 | Unknown Phase 2

• 1 other identifier: 2013/01233
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne

Keywords

Povidone Iodine; Safety; Efficacy; Acne treatment

Outcome Measures

Primary Outcomes (4)

• 5 point Acne Score

  0 Clear, indicating no inflammatory or noninflammatory lesions 1. Almost clear, rare noninflammatory lesions with no more than one papules/pustule; 2. Mild, some noninflammatory lesions, no more than a few papules/pustules but no nodules 3. Moderate, up to many noninflammatory lesions, may have some inflammatory lesions, but no more than one small nodule; 4. 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

  1. Score of itchiness 2. Score of scaling 3. Score of erythema 4. Score of pain

  2 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

Repigel DRUG

Repigel will be used as the intervention in the treatment group

Treatment Arm

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Mundipharma Pte Ltd.: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Sam SY Yang, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam SY Yang, Dr

CONTACT

85333992; samsyyang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

SG (1)