| CTRI Number |
CTRI/2017/06/008756 [Registered on: 05/06/2017] Trial Registered Prospectively |
| Last Modified On: |
02/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Laser for lichen planus pigmentosus |
|
Scientific Title of Study
|
Effect of Q-switched Nd-YAG laser on the clinical, pigmentary and immunological markers in the patients with lichen planus pigmentosus: A pilot study |
| Trial Acronym |
Nd-YAG in LPP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neetu Bhari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room no 4078A, Teaching block, 4th floor, Department of Dermatology and Venereology, Ansari Nagar
New Delhi DELHI 110049 India |
| Phone |
9650437049 |
| Fax |
|
| Email |
drntbhari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neetu Bhari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar
New Delhi DELHI 110049 India |
| Phone |
9650437049 |
| Fax |
|
| Email |
drntbhari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neetu Bhari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar
New Delhi DELHI 110049 India |
| Phone |
9650437049 |
| Fax |
|
| Email |
drntbhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Intramural Project All India Institute of Medical Sciences |
| Address |
Ansari nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Neetu Bhari |
All India Institute of Medical Sciences |
Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar New Delhi DELHI |
9650437049
drntbhari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lichen planus pigmentosus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nd-YAG laser |
6 sittings will be done on a lesion present at the covered body site, at 2 weekly interval |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with slate-gray hyperpigmented macules over neck, trunk or extremities
2. Histological evaluation showing minimal inflammatory infiltrate with presence of dermal pigment
|
|
| ExclusionCriteria |
| Details |
1. The presence of dense inflammatory infiltrate in dermis
2. Age less than 18 years
3. Patients not able to follow-up frequently
4. Patients with active infections, keloidal tendency, clotting abnormalities and serious systemic diseases
5. Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical improvement in pigmentation in patients with lichen planus pigmentosus with 6 sessions of Q switched Nd-YAG laser for 3 months at 2-weeks interval.
|
Patient and physician assessment of improvement as well as objective measurement of reduction in melanin pigment will be done at each visit and after 2 weeks of last laser visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detailed evaluation of the effect of laser on the dermal melanin pigment and melanophages in these patients. This will be done by comparing the pre and post treatment immunohistochemistry and mRNA expression analysis of MART-1, tyrosinase, MITF, CD68 and CD163. |
In five patients, post-treatment analysis done immediately one hour after the first laser session will help in determining the immediate effect of the laser on the destruction of melanophages and melanin. In the remaining five patients, this analysis done 2 weeks after the last laser visit will help in evaluation of long term effect of the laser on these cells. |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
16/06/2017 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lichen planus pigmentosus (LPP) is a pigmentary disorder characterized by persistent and asymptomatic slate-gray pigmentation over face, neck and flexures. This results in severe cosmetic disability and morbidity. Existing treatment options have shown minimal to nil improvement. The persistent pigmentation is secondary to persistent melanophages in the papillary dermis resistant to medical therapies. Q-switched Nd-YAG laser is known to disrupt the melanin pigment in the dermis via photothermolysis. We plan to undertake this pilot study to evaluate the effect of Q-switched Nd-YAG laser in the management of 10 patients of lichen planus pigmentosus. Six laser sessions will be performed at 2-weekly interval using a low fluence skin toning protocol. Patient and physician assessment of improvement as well as objective measurement of melanin and erythema index will be done at each visit and 2 weeks after the last laser session. Since, there are no proper study available evaluating the effect of Nd-YAG laser in LPP, we also plan to study the laser induced changes in immunological and pigmentary markers pre and post treatment which will be done by analysis of immunohistochemistry and mRNA expression of melanin pigment markers as MART-1, MITF and tyrosinase and macrophage markers as CD68 and CD163. This will be done one hour after the first laser session in five patients and after 2-weeks of last laser session in remaining five patients. |