NCT02126709

Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy

Status unknown Phase 2 Last updated 29 April 2014

What this trial tests

Phase 2 trial testing Repigel in Acne in 30 participants. Status unknown.

Timeline

1 June 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	National University Hospital, Singapore
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 June 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across Singapore

Drugs / interventions tested

• Repigel — full drug profile →

Conditions studied

• Acne — all drugs for Acne →

Sponsor

National University Hospital, Singapore

Who can join

Adults 13 to 60, any sex, with Acne. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 5 point Acne Score
  Time frame: 2 months
  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
• 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
  1. Score of itchiness 2. Score of scaling 3. Score of erythema 4. Score of pain

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and tolerability of liposomal polyvinylpyrrolidone-iodine hydrogel for the localized treatment of chronic infective, inflammatory, dermatoses: an uncontrolled pilot study.
   Augustin M, Goepel L, Jacobi A, Bosse B, et al · · 2017 · cited 18× · PMID 28989281 · DOI 10.2147/ccid.s141887