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临床试验/CTRI/2025/07/090256
CTRI/2025/07/090256尚未招募不适用

A COMPARATIVE STUDY ON EFFICACY OF INTENSE PULSE LIGHT THERAPY WITH ORAL PULSE STERIODS VERSUS ND YAG NEODYMIUM DOPED YTTRIUM ALUMINUM GARNET LASER WITH ORAL PULSE STEROIDS IN FACIAL LICHEN PLANUS PIGMENTOSUS

Chengalpet Medical Colllege and Hospital Chengalpet1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1. Pre and post treatment clinical pictures to look for improvement in the pigmentation

研究概览

简要总结

Lichen Planus Pigmentosus  is a rare variant of Lichen Planus manifesting more commonly in middle aged patients of color and is a distint clinical entity commonly encountered in Indian population. It is characterised by insiduos onset of blue- brown macules over the face, sun exposed areas and flexure commonly. Rarely , generalised involvement will be there. Cosmetic disfigurement is the main concern among the patients. It has a chronic course and may take many months to years to fade off even with treatment.

Treatment option includes Topical and Oral Steroids,Oral Isotretinoin, Topical Tacrolimus, oral Tranexamic acid ,Q-switched Nd-YAG . Very few case reports have been reported on treatment with IPL. Meire Brasil Parada et al reported IPL appears to be a promising, effective, and safe method in the aesthetic treatment of LPP. Swapnil Deepak Shah et al Q-switched Nd-YAG laser showed complete to near-complete resolution of pigment without much complications . So we are doing a comparative study among the two modalities

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex above 18 years Clinical criteria slate grey to violaceous to brown pigmentation Histopathologically proven Lichen Planus Pigmentosus Patients willing to give a written informed consent.

排除标准

  • Pregnant and lactating women Conditions mimicking LPP like Ashy dermatosis, Nevus of ota, macular amyloidosis, pigmented contact dermatitis, melasma Active infection Patients having photosensitivity / photosensitive dermatoses Patients who are on immunosupressants, uncontrolled diabetes, Hypertension, active tuberculosis.

结局指标

主要结局

1. Pre and post treatment clinical pictures to look for improvement in the pigmentation

时间窗: 0,6,9 months FOLLOW UP

2.Dermascopic assessement will also be done pre treatment and post treatment to look for dots and globular pattern, reticular pattern, hem like pattern, pseudo-reticular pattern

时间窗: 0,6,9 months FOLLOW UP

3. DPASI scoring system will be done

时间窗: 0,6,9 months FOLLOW UP

4. SKINDEX 16- for assessment of Emotional,functional and symptom domains of the patients

时间窗: 0,6,9 months FOLLOW UP

Interval 0 month, 6 months, 9 months

时间窗: 0,6,9 months FOLLOW UP

次要结局

  • 1. Erythema, irritation & burning sensation immediately after laser treatment(2. Post inflammatory depigmentation after completing 6 sessions of ND YAG laser or IPL therapy)

研究者

发起方
Chengalpet Medical Colllege and Hospital Chengalpet
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Meenalochini

Chengalpet medical College and hospital

研究点 (1)

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