Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Scar thickness measured by digital calliper
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.
详细描述
Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.
Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects with age range 18-60 years;
- •Subject with hypertrophic scar from abdominal surgery for at least 3 months;
- •Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months
排除标准
- •Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
- •Subject who smoke cigarette;
- •Subject who was treated with Intralesional corticosteroid
研究组 & 干预措施
Laser+Topical corticosteroid
Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side
干预措施: 0.05% Clobetasol propionate (Drug)
Laser+Petrolatum gel
Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side
干预措施: Petrolatum gel (Drug)
结局指标
主要结局
Scar thickness measured by digital calliper
时间窗: change from baseline in scar thickness at 6 months
次要结局
- Patient and observer scar assessment scale(Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University