| CTRI Number |
CTRI/2023/07/055395 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
To compare the efficacy of topical 0.1% Betamethasone valerate and fractional co2 laser with topical 0.1% Betamethasone valerate in treatment of Alopecia areata |
|
Scientific Title of Study
|
A Comparitive study to assess efficacy of topical 0.1% betamethasone valerate versus fractional co2 laser with 0.1% topical betamethasone valerate in treatment of alopecia areata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKVignesh kumar |
| Designation |
1rst year Postgraduate |
| Affiliation |
Chengalpattu Medical College and hospital |
| Address |
Department of DVL
Chengalpattu Medical College and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7418561171 |
| Fax |
|
| Email |
vigneshkumarsmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V.SRIDHAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Chengalpattu Medical College and hospital |
| Address |
Department of DVL
Chengalpattu Medical College and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9994873182 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKVignesh kumar |
| Designation |
1rst year Postgraduate |
| Affiliation |
Chengalpattu Medical College and hospital |
| Address |
Department of DVL
Chengalpattu Medical College and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7418561171 |
| Fax |
|
| Email |
vigneshkumarsmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chengalpattu Medical College and hospital Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr KVignesh kumar |
| Address |
Chengalpattu Medical College hospital Chengalpattu |
| 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 |
| KVignesh kumar |
Chengalpattu Medical College, Chengalpattu. |
ROOM NO 44, FLOOR NO 2,Dermatology OPD
Kancheepuram
TAMIL NADU |
07418561171
vigneshkumarsmc@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: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fractional co2 laser with 0.1% betamethasone valerate |
Group B- patients with alopecia areata will be treated with fractional co2 laser (energy-30mJ, duration-0.6msec, single passe). Then 0.1% betamethasone cream applied immediately after laser session. Patient advised to continue topical 0.1% betamethasone valerate twice daily in between laser session.
duration- laser treatment given every 2 weeks maximum of 6 sessions, 0.1% betamethasone valerate ointment for topical application for 3 months |
| Comparator Agent |
TOPICAL 0.1% BETAMETHASONE VALERATE ointment for alopecia areata |
Group A patient treated with 0.1% topical betamethasone valerate twice daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with alopecia areata patients will be divided into Group A & Group B. Each group comprising of 40 patients. 40 patients in Group A will be use topical 0.1% betamethasone alone 40 patients in Group B will treated with fractional co2 with topical 0.1% betamethasone. Maximum 6 sittings will be given at 2 weeks interval. Patient will receive no other therapies during study |
|
| ExclusionCriteria |
| Details |
Before starting the study
Pregnant and lactating women.
Women planning for pregnancy
Children less than 14 years
During Study
If patient wants alternate treatment during the study.
If patient wants to discontinue the treatment.
|
|
|
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 |
Hair regrowth in alopecia patches
|
24 weeks post study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| atrophy of skin |
12 weeks post study |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2023 |
| 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="1"
Months="5"
Days="20" |
|
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
|
Alopecia areata is a complex genetic immune mediated inflammatory non scarring hair loss that results in decrease in quality of life. It may affect any hairy area in body and is usually reversible. Alopecia areata postulated to be hair specific autoimmune disease, with genetic factors playing role in disease susceptibility and severity. In acute progressive stage of alopecia areata , lymphocytic infiltration are seen around and sometimes with in the hair bulb region of anagen follicles Despite the presence of this inflammatory infiltrate, the follicle retains its potential to produce hair, implying that the follicular stem cells remain viable. The chronic relapsing nature of alopecia areata and its profound effect on physical appearance make the development this condition distressing and life changing event for many affected individuals |