Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin: An Intra-individual Study With Blinded Outcome Assessment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in appearance of striae with GAIS
研究概览
简要总结
The study aims to explore the potential of combination therapy with fractional radiofrequency and topical tretinoin for treatment and overall improvement of striae albae. We also aim to assess subject satisfaction, local skin responses and adverse effects/reactions in relation to the treatments, alone and in combination.
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
- Single (Outcomes Assessor)
盲法说明
Primary outcome assessment is blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has provided written informed consent
- •Subject is 18 years of age or older
- •Fitzpatrick skin type I-III
- •Striae albae (grade II-IV) ≥1 year of age and ≥ 4 lesions with a length of ≥ 2 cm each
- •Women of childbearing potential are not pregnant (confirmed by a negative u-HCG prior to study treatments) and use a safe contraceptive method prior to treatments.
排除标准
- •Severe concurrent conditions such as cardiac disorders or poorly regulated diabetes
- •History of skin disorders such as keloids, abnormal wound healing or very fragile skin
- •History of heat-stimulated disease such as herpes simplex in the treatment area
- •History of bleeding coagulopathies or use of anti-coagulants
- •Surgery in the treatment area past 6 months or before complete healing
- •Tattoo or permanent make-up in treatment area
- •Excessively tanned skin from sun, tanning bed or tanning creams last 2 weeks
- •Dermabrasion, resurfacing, soft tissue/fat injections or chemical peeling in treatment area the past 3 months
- •Abnormal skin (e.g. rash, infection, dermatitis) at the treatment area at the time of inclusion
- •Treatment with Isotretinoin within the past 6 months
- •Use of non-steroidal anti-inflammatory drugs 1 week prior to treatment
- •Known allergies to tretinoin or lidocaine/prilocaine
- •History of cancer including pre-malignant moles
- •Impaired immune system due to immunosuppressive disease or medication
- •Electronic device implant
- •Any implantable metal piece or permanent chemical substance in treatment area
- •If female; lactating, pregnant or planning on becoming pregnant during the study
- •Non-eligibility at the discretion of the investigator
研究组 & 干预措施
Combination therapy: Fractional radiofrequency and topical tretinoin
3 study treatments: at baseline, 1-month, 2-month with subsequent application of topical tretinoin. Home application of tretinoin between study visits
干预措施: Fractional radiofrequency and topical Tretinoin (Combination Product)
Fractional radiofrequency
3 study treatments: at baseline, 1-month, 2-month
干预措施: Fractional radiofrequency (Device)
Topical tretinoin
Application at study visits and home application between study visits
干预措施: Topical Tretinoin (Drug)
结局指标
主要结局
Improvement in appearance of striae with GAIS
时间窗: Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up
Standardized clinical photos from baseline and follow-up comparing treatments and assessed by blinded evaluator on the Global Aesthetic Improvement Scale (GAIS)
次要结局
- Evaluation of striae with POSAS(Baseline - 20 weeks follow-up (12 weeks after last treatment))
- Evaluation of striae with imaging(Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up)
- Safety: LSR and AE/AR(Baseline, at 4 weeks, 8 weeks and 20 weeks follow-up)
- Subject satisfaction(Baseline - 20 weeks follow-up (12 weeks after last treatment))
研究者
Merete Haedersdal
Consultant in Dermatology, Clinical Professor
Bispebjerg Hospital