| CTRI Number |
CTRI/2023/11/059870 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical signs and symptoms, microscopic examination of tissue changes and Colour changes in Lichen Planus Pigmentosus in a tertiary care hospital |
|
Scientific Title of Study
|
Clinicopathological, Dermoscopic and Colorimetric analysis in Lichen Planus Pigmentosus in a tertiary care hospital: A cross-sectional study |
| 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 Youvalakshmi S |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
NO.72, Department of dermatology, Venereology and Leprology,
Kalvi Vallal N. Kesavan Salai,
Kalitheerthalkuppam, Madagadipet,
Puducherry- 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9787971430 |
| Fax |
|
| Email |
youvalakshmi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthikeyan K |
| Designation |
Professor and head |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room no 72, Department of Dermatology, Venereology and Leprosy.
Kalvi Vallal N Kesavan Salai,
Kalitheerthalkuppam, Madagadipet,
Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9787971430 |
| Fax |
|
| Email |
karthikderm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Youvalakshmi S |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
NO.72, Department of dermatology, Venereology and Leprology,
Kalvi Vallal N. Kesavan Salai,
Kalitheerthalkuppam, Madagadipet,
Puducherry- 605 107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9787971430 |
| Fax |
|
| Email |
youvalakshmi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| (IADVL) The Indian Association of Dermatologists, Venereologists and Leprologists |
|
|
Primary Sponsor
|
| Name |
Dr Youvalakshmi S |
| Address |
NO.72, Department of dermatology, Venereology and Leprology,
Kalvi Vallal N. Kesavan Salai,
Kalitheerthalkuppam, Madagadipet,
Puducherry- 605 107
Puducherry- 605 110. |
| Type of Sponsor |
Other [Self] |
|
|
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 Youvalakshmi S |
Sri Manakula Vinayagar Medical College and Hospital |
Room no. 72, Ground floor,
Department of Dermatology, Venereology and Leprosy.
Kalvi Vallal N. Kesavan Salai,
Kalitheerthalkuppam, Madagadipet,
Puducherry- 605 107
Pondicherry
PONDICHERRY |
9787971430
youvalakshmi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayagar Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical and histopathological features of lichen planus pigmentosus will be included in this study. |
|
| ExclusionCriteria |
| Details |
Any contraindications to biopsy like bleeding disorders will be excluded from this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinicopathological and dermoscopic features of lichen planus pigmentosus.
To quantify the intensity of pigmentation in lichen planus pigmentosus by colorimetric analysis
|
1 week to 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To quantify the intensity of pigmentation in lichen planus pigmentosus by colorimetric analysis
|
1 week to 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/11/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will help us in finding the clinicopathological and dermoscopic features of Lichen Planus Pigmentosus in south Indian population.Accurate diagnosis and confirmation of lichen planus pigmentosus can be made only from histopathological features. Colorimetric analysis is a novel upcoming technology used in various pigmentary skin disorders. The findings of the colorimetric analysis may help us in classifying the severity and planning the treatment modality accordingly in lichen planus pigmentosus |