Efficacy and safety of low fluence Q-switched Nd-YAG laser for the treatment of facial lichen planus pigmentosus or pigmented contact dermatitis: a prospective randomized control study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physician assessment: Two dermatologists blinded to the treatment protocol would independently assess pigment lightening using digital photographs with the following grading scale.
研究概览
简要总结
Justification:
Both facial lichen planus pigmenetosus (LPP) and pigmented contact dermatitis (PCD) are a cause of marked cosmetic and psychosocial distress, as they lead to slate grey to brownish pigmentation. No standard care of treatment is available till date. The eveidence of use of low fluence Q switched Nd-YAG laser in these conditions is limited to case report and case series. Hence there is a need for a randomized controlled trial.
Research question:
Is low fluence Q switched Nd-YAG laser effective and safe in inactive facial LPP and PCD in darker skin individuals?
Hypotheis:
When 1064 nm low fluence Q switched Nd-YAG laser is periodically delivered with multiple passes using larger spot size, it leads to destruction of dermal melanin (seen in LPP and PCD) without causing cell death and thereby minimizing the side effects like pigmentary changes in darker skin individuals. This in turn leads to rapid clearing of pigmentation.
Primary objective:
To study the efficacy and safety of low fluence 1064 nm Q switched Nd YAG laser in cases of facial LPP and PCD.
Secondary objective:
To study the impact of treatment on the quality of life and study the histopathological changes before and after treatment.
Materials and methods:
Study design: Randomized control trail
study setting: Department of Dermatology and Department of pathology, AIIMS, New Delhi
Duration of study: one year
Sample size: 30 in each group.
Intervention:
Group 1 (Laser arm):
Fortnightly sessions of Q-swtiched Nd YAG laser till 12 sessions or 90% clearance of pigmentation whichever is earlier.
Laser parameters: Wavelength: 1064 nm; Fluence: 2 J/ cm2 ; spot size: 6 mm; frequency: 10 hertz; passes: 10-20 or till mild frosting or warmth
Regular physical sunscreen application till the intervention period.
Group 2 (non-laser arm):
Only regular physical sunscreen application.
Investigations:
Digital Photography: using SLR camera Nikon D5600
Spectrophotometry
Dermoscopy: using Heine Delta 20T, polarized mode
(Both dermoscopy and spectrophotometry will be done at baseline and then monthly till the intervention period at 2 fixed points: 1. highest point of zygomatic arch near the lateral canthus of eye 2. intersection point of imaginary line drawn through the angle of mouth, at the anterior border of masseter.)
Skin biopsy: to look for pigment reduction at baseline and end of treatment (Stained with Hematoxylin and eosin).
Quality of life: Change in scores of dermatology life quality index (DLQI) questionnaire at baseline and end of intervention.
Outcome assessment parameters:
Physician global assessment (blinded to clinical details)
Patient global assessment
Spectrophotometry (change in erythema index and melanin index)
Dermoscopy
Histopathology
Quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients of lichen planus pigmentosus and pigmented contact dermatitis fulfilling following criteria: 1.18-50 years of age 2.no progression of pigmentation for past 3 months 3.histologically inactive (defined as absence of interface dermatitis).
排除标准
- •1.Age <18 years 2.Coexistent active lichen planus 3.Previous history of laser treatment during the last 12 months 4.Patients on systemic or topical therapy for the past 1 month 5.Not willing to participate in the study 6.Patients having photosensitivity 7.Patients with hypersensitivity to prilocaine or lignocaine.
结局指标
主要结局
Physician assessment: Two dermatologists blinded to the treatment protocol would independently assess pigment lightening using digital photographs with the following grading scale.
时间窗: 24 weeks
o0-25% (none/ slightly lightening)
时间窗: 24 weeks
o26-50% (moderate lightening)
时间窗: 24 weeks
o51-75% (significant lightening)
时间窗: 24 weeks
o76-95% (very good lightening)
时间窗: 24 weeks
o96-100% (excellent lightening)
时间窗: 24 weeks
Also a comparison of side effects in the two groups will be done at the end of trial.
时间窗: 24 weeks
次要结局
- Patient assessment: Patient’s subjective assessment will be noted on a visual analog scale ranging from 0-10, (0 - worst and 10 - best results)
- Spectrophotometric assessment: Mean change in MI and EI will be calculated in each arm at every month and compared.
- Histopathological assessment: To compare the pigment reduction in pre and post treatment biopsies.
- Dermoscopic assessment: The changes in dermoscopy will be compared before and after treatment.
- Quality of life assessment: patients will be asked to fill Dermatology quality of life questionnaire (DLQI) at the beginning and the end of study, to measure the impact on quality of life with intervention.