A RANDOMISED PROSPECTIVE SPLIT FACE STUDY COMPARING THE EFFICACY AND SAFETY OF DIODE LASER MONOTHERAPY (810nm) VS SEQUENTIAL THERAPY OF DIODE LASER PLUS LONG PULSED ND YAG LASER(1064nm) IN THE TREATMENT OF IDIOPATHIC FACIAL HIRSUITISM
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- IADVL
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of Diode laser as monotherapy vs Efficacy of sequential therapy of diode laser plus long pulsed Nd YAG laser(1064nm) in the treatment of idiopathic facial hirsutism
研究概览
简要总结
· The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study.
· A detailed history including the duration of disease, associated medical conditions, treatment history and family history is to be taken.
· The patients are randomized according to computer generated random number sequence and allocated to two interventional groups.
· One group will be treated with Diode laser (810nm)
· The other group will be treated sequentially with diode laser(810nm) and Long pulse Nd-YAG laser (1064nm)
· The outcome (efficacy) will be evaluated by seeing the improvement in visual analog scale, subject self- assessment, physician and subject global aesthetic improvement and Ferriman Galleway scoring.
· Clinical images will be taken at the starting of therapy and at monthly intervals to look for the improvement, with due care that the patient’s identity is not revealed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of facial hirsutism aged between 18 and 45 years .
- •Failure to conventional therapy.
排除标准
- •Grade 1 hair(Fine vellus hair)
- •Any previous laser treatment to the study area within the last 6 months.
- •Any hormonal dysfunction, waxing, depilation, electrolysis or bleach use within six weeks of entry into the study.
- •A history of keloid scarring.
- •Immunosuppression.
结局指标
主要结局
Efficacy of Diode laser as monotherapy vs Efficacy of sequential therapy of diode laser plus long pulsed Nd YAG laser(1064nm) in the treatment of idiopathic facial hirsutism
时间窗: Follow up monthly once for 6 months and every 2 monthly for 4 months.
次要结局
- Safety of Diode laser monotherapy vs sequential therapy of diode laser plus long pulsed Nd YAG laser(1064nm) in the treatment of idiopathic facial hirsutism.(At the end of follow up that is at 10 months)
研究者
Dr Maitreyee Panda
IMS and SUM Hospital