| CTRI Number |
CTRI/2019/09/021361 [Registered on: 20/09/2019] Trial Registered Prospectively |
| Last Modified On: |
20/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Laser treatment of lichen planus pigmentosus and pigmented contact dermatitis. |
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Scientific Title of Study
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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.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Sethuraman |
| Designation |
Professor, Dept of Dermatology and Venereology |
| Affiliation |
All India Instiute of Medical Sciences |
| Address |
R. no. 4070, Teaching block, AIIMS, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
aiimsgsr@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr G Sethuraman |
| Designation |
Professor, Dept of Dermatology and Venereology |
| Affiliation |
All India Instiute of Medical Sciences |
| Address |
R. no. 4070, Teaching block, AIIMS, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
aiimsgsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Sethuraman |
| Designation |
Professor, Dept of Dermatology and Venereology |
| Affiliation |
All India Instiute of Medical Sciences |
| Address |
R. no. 4070, Teaching block, AIIMS, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
011-26593217 |
| Fax |
|
| Email |
aiimsgsr@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi |
|
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Primary Sponsor
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| Name |
All India Institute of Medical Sceinces |
| Address |
Department of dermatology AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Sethuraman |
All India Insitute of Medical Sciences, New Delhi |
Room no. 1143, Skin OPD, Department of Dermatology and Venereology, AIIMS, New Delhi
South West
DELHI |
011-26593217
aiimsgsr@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Group 1 (laser arm) |
Fortnightly Q Switched Nd Yag Laser (Med-lite C6 Hoya Con Bio Inc., Fremont, CA, USA) with a fluence 2.0 J/cm2, spot size 6 mm, frequency 10 Hz and 10 to 20 passes or until mild frosting and warmth occurs.
Number of laser sessions: Twelve or until complete clearance of pigmentation whichever is earlier.
Physical sunscreen thrice a day for the intervention period.
|
| Comparator Agent |
Group 2 (non-laser arm) |
No laser treatment except for sunscreen for a similar duration as in Group 1. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
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| ExclusionCriteria |
| Details |
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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
Physician assessment: Two dermatologists blinded to the treatment protocol would independently assess pigment lightening using digital photographs with the following grading scale.
o 0-25% (none/ slightly lightening)
o 26-50% (moderate lightening)
o 51-75% (significant lightening)
o 76-95% (very good lightening)
o 96-100% (excellent lightening)
Also a comparison of side effects in the two groups will be done at the end of trial. |
24 weeks |
|
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Secondary Outcome
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| Outcome |
TimePoints |
Patient assessment: Patient’s subjective assessment will be noted on a visual analog scale ranging from 0-10, (0 - worst and 10 - best results)
|
24 weeks |
Spectrophotometric assessment: Mean change in MI and EI will be calculated in each arm at every month and compared.
|
4, 8, 12, 16, 20, 24 weeks |
Histopathological assessment: To compare the pigment reduction in pre and post treatment biopsies.
|
24 weeks |
Dermoscopic assessment: The changes in dermoscopy will be compared before and after treatment.
|
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.
|
24 weeks |
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Target Sample Size
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Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
01/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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
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