Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
研究概览
简要总结
Stria alba (aka white or atrophic stretch marks) is a very common dermatologic condition that causes major psychological distress to those afflicted. We study the effect of low level light therapy using infra red diode 808/915 nm laser in comparison to fractional CO2 alone and combined both therapies.
详细描述
All patients will be subjected to the following:
- Written informed consent.
- Detailed history and clinical evaluation.
The treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment.
Patients will be allocated according to randomization into one of 3 arms:
Arm A will be treated by fractional CO2 laser. Arm B will be treated by low level light therapy (LLLT). Arm C will be treated with a combination of fractional CO2 laser and LLLT.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, above the age of 18 years old, with stria alba.
- •Both genders.
排除标准
- •Pregnant or lactating females.
- •Subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study.
- •Subjects who applied topical corticosteroids, retinoid, vitamin C, or vitamin E within 3 months prior to the study.
- •Subjects who orally took retinoids or corticosteroids within 3 months.
- •Subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer.
结局指标
主要结局
Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
时间窗: 3 months
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (\<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (\>76%).
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)
时间窗: 3 months
Patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire
Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)
时间窗: 3 months
Patients will be assessed before and after treatment by one unblinded and one blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (\<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (\>76%).
次要结局
- Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1(1 month)
- Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1(1 month)
- Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)(3 months)
- Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1(1 month)
- Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)(3 months)
研究者
Marina Mikhail
Visiting resident
Kasr El Aini Hospital