AcnePhase 2NCT02126709
The Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
A Phase 2 study testing Repigel in people with Acne, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Acne
- What is being tested?
- Repigel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Thyroid Dysfunction
- Pregnancy, Breast feeding
- History of hypersensitivity to iodine
- History of renal impairment
- Using OCPs
- Using concurrent medications known to exacerbate acne
Show all 14Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Hospital
Singapore, Singapore, 119074
Sam Yang, Dr, 85333992, samsyyang@gmail.com
About this study
Official title: Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
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.
Read more
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.
Read the detailed description
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
- Capture baseline demographics
- Age b. Sex c. Race d. Lesion counts - total, inflammatory, non-inflammatory e. FDA score
- Efficacy evaluation
- 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.
- Safety Evaluation
- Score of itchiness b. Score of scaling c. Score of erythema d. Score of pain
- Primary end points -
- 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
- Secondary end point
- 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.
- Conditions
- Acne
- Being tested
- Repigel
- Keywords
- Povidone Iodine, Safety, Efficacy, Acne treatment
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepigelDrug
Repigel will be used as the intervention in the treatment group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 point Acne Score
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.
Measured: 2 months
Lesional Counts
- Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions
Measured: 2 months
Effect on Quality of Life
Scoring of the Cardiff Acne Disability Index.
Measured: 2 months
Safety
- Score of itchiness
- Score of scaling
- Score of erythema
- Score of pain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Sam SY Yang, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126709
- Sponsor's protocol ID
- 2013/01233
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
- ClinicalTrials.gov ID
- NCT02126709
- Acronym / sponsor ID
- 2013/01233
- Conditions
- Acne
- Keywords
- Povidone Iodine, Safety, Efficacy, Acne treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Capture baseline demographics
- Age b. Sex c. Race d. Lesion counts - total, inflammatory, non-inflammatory e. FDA score
- Efficacy evaluation
- 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.
- Safety Evaluation
- Score of itchiness b. Score of scaling c. Score of erythema d. Score of pain
- Primary end points -
- 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
- Secondary end point
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: RepigelName: 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 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 |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Thyroid Dysfunction
- Pregnancy, Breast feeding
- History of hypersensitivity to iodine
- History of renal impairment
- Using OCPs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RepigelRepigel will be used as the intervention in the treatment group | Drug | Treatment Arm |
Primary outcome
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 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
1. Score of itchiness 2. Score of scaling 3. Score of erythema 4. Score of pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam SY Yang, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repigel in people with Acne, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam SY Yang, Dr (85333992, samsyyang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 point Acne Score (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.