Phase 2 Study of the Efficacy and Safety of 3% Povidone-Iodine in Acne Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lesional Counts
研究概览
简要总结
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.
详细描述
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
a. Age b. Sex c. Race d. Lesion counts - total, inflammatory, non-inflammatory e. FDA score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mild to moderate inflammatory acne - grade 2 to
- •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
排除标准
- •Thyroid Dysfunction
- •Pregnancy, Breast feeding
- •History of hypersensitivity to iodine
- •History of renal impairment
- •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,
研究组 & 干预措施
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
- 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
干预措施: Repigel (Drug)
结局指标
主要结局
Lesional Counts
时间窗: 2 months
b. Total lesional count c. No. of inflammatory lesions d. No. of non-inflammatory lesions
Effect on Quality of Life
时间窗: 2 months
Scoring of the Cardiff Acne Disability Index.
Safety
时间窗: 2 months
1. Score of itchiness 2. Score of scaling 3. Score of erythema 4. Score of pain
5 point Acne Score
时间窗: 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.
次要结局
未报告次要终点