aser treatment of lichen planus pigmentosus and pigmented contact dermatitis.
Not Applicable
- Conditions
- Health Condition 1: L818- Other specified disorders of pigmentation
- Registration Number
- CTRI/2019/09/021361
- Lead Sponsor
- All India Institute of Medical Sceinces
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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)
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician assessment: Two dermatologists blinded to the treatment protocol would independently assess pigment lightening using digital photographs with the following grading scale. <br/ ><br>o0-25% (none/ slightly lightening) <br/ ><br>o26-50% (moderate lightening) <br/ ><br>o51-75% (significant lightening) <br/ ><br>o76-95% (very good lightening) <br/ ><br>o96-100% (excellent lightening) <br/ ><br> <br/ ><br>Also a comparison of side effects in the two groups will be done at the end of trial.Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method Dermoscopic assessment: The changes in dermoscopy will be compared before and after treatment. <br/ ><br>Timepoint: 24 weeks;Histopathological assessment: To compare the pigment reduction in pre and post treatment biopsies. <br/ ><br>Timepoint: 24 weeks;Patient assessment: Patientâ??s subjective assessment will be noted on a visual analog scale ranging from 0-10, (0 - worst and 10 - best results) <br/ ><br>Timepoint: 24 weeks;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. <br/ ><br>Timepoint: 24 weeks;Spectrophotometric assessment: Mean change in MI and EI will be calculated in each arm at every month and compared. <br/ ><br>Timepoint: 4, 8, 12, 16, 20, 24 weeks