| CTRI Number |
CTRI/2025/07/090256 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lichen planus pigmentosus- To compare the efficacy between ND YAG laser Vs Intense pulse light |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenalochini |
| Designation |
Postgraduate |
| Affiliation |
Chengalpet medical College and hospital |
| Address |
Department of DVL Chengalpet Medical College and Hospital
Chengalpet
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9751469266 |
| Fax |
|
| Email |
lochini23.vasa.mani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayakalyani |
| Designation |
Assistant professor |
| Affiliation |
Chengalpet medical College and hospital |
| Address |
Department of DVL
Chengalpet Medical College and Hospital
Chengalpet
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9600772668 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayakalyani |
| Designation |
Assistant professor |
| Affiliation |
Chengalpet medical College and hospital |
| Address |
Department of DVL
Chengalpet Medical College and Hospital
Chengalpet
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9600772668 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL Chengalpattu Medical College and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
|
|
Primary Sponsor
|
| Name |
Chengalpet Medical Colllege and Hospital Chengalpet |
| Address |
Department of DVL Chengalpattu Medical College and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrD Meenalochini |
Chengalpet Medical College and Hospital, Chengalpet |
ROOM NO 44, FLOOR
NO 2,Dermatology
OPD
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9751469266
lochini23.vasa.mani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee,Chengalpattu Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intense pulse light with Oral mini pulse with dexamethasone |
Intense pulse light Pigment( 530nm ) and vascular(640nm) filters will be used with exposure time 12 msec, fluence of 28 mj/cm2 - every 4 weeks for 6 sessions
Oral pulse therapy with
T.Dexamethasone 5mg ORAL- 2 days a week [ preferably Saturday and Sunday] for 4 weeks
then 4mg- 2 days a week for 2 weeks
then 3mg- 2 days a week for 2 weeks
then 2mg- 2 days a week for 2 weeks
then 1mg- 2 days a week for 2 weeks
Total duration of 12 weeks. |
| Intervention |
ND YAG laser with oral mini pulse with dexamethasone |
ND-YAG 1064nm Q-switched ND-YAG laser : spot size 6 mm, 400mJ of energy , and frequency of 5Hz single pass is given over the lesions on the face . Total number of sessions is 6 which is done at 4 weeks apart.
Oral steroid pulse therapy with
T.Dexamethasone 5mg- 2 days a week for 4 weeks [ Preferably Saturday and Sunday]
then 4mg- 2 days a week for 2 weeks
then 3mg- 2 days a week for 2 weeks
then 2mg- 2 days a week for 2 weeks
then 1mg- 2 days a week for 2 weeks
Total duration of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pre and post treatment clinical pictures to look for improvement in the pigmentation
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
3. DPASI scoring system will be done
4. SKINDEX 16- for assessment of Emotional,functional and symptom domains of the patients
Interval 0 month, 6 months, 9 months |
0,6,9 months FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Erythema, irritation & burning sensation immediately after laser treatment
2. Post inflammatory depigmentation after completing 6 sessions of ND YAG laser or IPL therapy
3. If any patient in developing side Effects of oral steroids such as Hypertension, Diabetes & cushingoid features. Complete blood count ,Random blood glucose,blood pressure will be monitored every month |
1. Immediately after procedure
2. After completing every sessions of ND YAG or IPL
3. 3 months after completing all 6 sessions |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
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