| CTRI Number |
CTRI/2024/07/071528 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of localized hair loss
over the scalp using newer modalities. |
|
Scientific Title of Study
|
Cryotherapy with intralesional steroids Versus intralesional pentoxifylline in the treatment of Recalcitrant Alopecia Areata: A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana Gopalakrishnan |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research, Kolar. |
| Address |
Department of Dermatology Venereology and Leprosy, Sri Devaraj Urs medical college, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
9487087687 |
| Fax |
|
| Email |
anjanambbs.0207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekar T S |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research, Kolar. |
| Address |
Department of Dermatology Venereology and Leprosy, Sri Devaraj Urs medical college, Kolar.
KARNATAKA
563103
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
rajashekardermat@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anjana Gopalakrishnan |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research, Kolar. |
| Address |
Department of Dermatology Venereology and Leprosy, Sri Devaraj Urs medical college, Kolar.
KARNATAKA
563103
India |
| Phone |
9487087687 |
| Fax |
|
| Email |
anjanambbs.0207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka 563103
India |
|
|
Primary Sponsor
|
| Name |
ANJANA GOPALAKRISHNAN |
| Address |
SRI DEVARAJ URS MEDICAL COLLEGE KOLAR KARNATAKA-563103
INDIA |
| 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 ANJANA |
R.L Jalappa Hospital |
Room no:26,Department of Dermatology Venereology and Leprosy
Kolar
KARNATAKA |
9487087687
anjanambbs.0207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Cryotherapy with intralesional steroids |
Cryotherapy with intralesional injection of triamcinolone acetonide 5mg/ml done every 2 weeks for maximum of 5 sittings |
| Comparator Agent |
2.Intralesional pentoxifylline |
1ml(20mg) of intralesional pentoxifylline(100mg/5ml)is injected over alopecic patch every 2 weeks up to 5 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features suggestive of Recalcitrant alopecia areata over the scalp. |
|
| ExclusionCriteria |
| Details |
1.Patients with other systemic illness- cardiac hepatic and renal disorders
2.cold intolerance
3.pregnant and lactating women
4.patient not willing for study
5.severely immunocompromised individuals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of hair growth with Global Photographic Assessment scale.
2.Assessment of side effects of cryotherapy with intralesional steroids and intralesional pentoxifylline |
1.Assessment of hair growth with Global Photographic Assessment scale at 1st 2nd 3rd 4th 5th sittings
2.Assessment of side effects of cryotherapy with intralesional steroids and intralesional pentoxifylline at 1st 2nd 3rd 4th 5th sittings |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of hair growth with Global Photographic Assessment scale & patient satisfaction
2.Assessment of efficacy of cryotherapy with intralesional steroids & intralesional pentoxifylline using LAD Score & Global Photographic Assessment Scale |
1.Grading of improvement in hair growth & efficacy at 1st 2nd 3rd 4th 5th sittings using LAD Score.
2.Assessment of efficacy using Global Photographic Assessment scale at 1st 2nd 3rd 4th 5th sittings |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 compares cryotherapy with intralesional steroids with that of intralesional pentoxifylline in the treatment of Recalcitrant Alopecia areata. However there is a paucity of literature comparing the efficacy of both the treatment modalities. Hence this study is undertaken. |