| CTRI Number |
CTRI/2025/09/094101 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Efficacy and Safety of 308 nm Excimer laser (targeted phototherapy) and Intralesional Triamcinolone (steroid) in treating Alopecia Areata (autoimmune disorder characterized by non-scarring hair loss) |
|
Scientific Title of Study
|
Comparison of Efficacy and Safety of 308 nm Excimer laser and Intralesional Triamcinolone in treating Alopecia Areata |
| 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 Khushboo Ajaykumar Heda |
| Designation |
Postgraduate Resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9767754000 |
| Fax |
|
| Email |
drkhushboo22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Ovhal |
| Designation |
Professor and HOD, Dept of Dermatology |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9422649911 |
| Fax |
|
| Email |
drajayovhal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Ovhal |
| Designation |
Professor and HOD, Dept of Dermatology |
| Affiliation |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9422649911 |
| Fax |
|
| Email |
drajayovhal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur, Maharashtra, India 413512 |
|
|
Primary Sponsor
|
| Name |
Dr. Khushboo Ajaykumar Heda |
| Address |
Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur |
| 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 Khushboo Ajaykumar Heda |
Vilasrao Deshmukh Government Medical College and Hospital |
OPD no. 115, Department of Dermatology, Vilasrao Deshmukh Government Medical College, Latur 413512
Latur
MAHARASHTRA |
9767754000
drkhushboo22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, Vilasrao Deshmukh Government Medical College, Latur, MH |
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 |
308 nm Excimer Laser |
Patients will be given therapy twice weekly by Excimal Elite 308nm Excimer UV Light System, but not on consecutive days. The treatment will be started at 300 mJ/cm2 and will be increased by 50mJ/cm2 every visit until fine or asymptomatic erythema becomes visible. If patient develops erythema that lasts for more than 24 hours or and symptomatic erythema the dose will be reduced to previous tolerable dose. If erythema persists for more than 2 days or and patient develops intolerable burning, itching, erythematous papules or vesicles the treatment will be skipped till resolution of above and excimer laser therapy will be restarted at 100mJ/cm2 less than the dose at which above occurred. Patients will receive 24 sessions in 12 weeks of the study. |
| Comparator Agent |
Intralesional Triamcinolone |
Patients will be given Intralesional Triamcinolone 5mg/ml every 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who give consent for the study
2. Age more than 7 years and less than 60 years
3. Patients with a diagnosis of patch type of alopecia areata
4. Patients presenting with less than 5 patches sizes 2cm to 5cm.
5. Subjects having patch for atleast 3 months with no evidence of hair regrowth
6. Patients who have never taken treatment or who have not taken treatment for atleast 8 weeks
7. Patients who are willing and capable of cooperating to the extent and degree required by the protocol.
|
|
| ExclusionCriteria |
| Details |
1. Patients who do not give consent.
2. Patients who received treatment within last 8 weeks.
3. Patients with alopecia totalis or alopecia universalis.
4. Patients with known photosensitivity like polymorphous light eruption, connective tissue diseases, porphyria, xeroderma pigmentosum.
5. Pregnant or breast feeding.
6. History of previous skin cancer.
7. Patient with history of existing skin disease affecting the scalp such as psoriasis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients with more than 50% hair regrowth will be considered successful treatment.
Response to treatment is graded according to therapeutic efficacy which is calculated using Severity of Alopecia tool score (SALT).
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Treatment outcome rates
Clinically
a. Presence of positive or negative alopecia areata hair pull test.
b. Presence or absence of short regrowing hair as evident clinically
c. Percentage regrowth on 4 point scale
Tricoscopic Findings
a. Black dot
b. Broken hair
c. Tapering hair (exclamation mark hair)
d. Coudability hair
2. Patient satisfaction
Poor = 0-25 percentage Hair regrowth
Fair = 26-50 percentage Hair regrowth
Good = 51-75 percentage Hair regrowth
Excellent = more than 75 percentage Hair regrowth
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
10/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
While both 308 nm Excimer laser therapy and
intralesional triamcinolone injections have shown efficacy in the treatment of
alopecia areata, there is a lack of direct comparative studies evaluating their
effectiveness. Further research is needed to determine the optimal treatment
approach for alopecia areata based on efficacy, safety, and patient
preferences. |