| CTRI Number |
CTRI/2024/09/073322 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Topical steroids versus topical tacrolimus with microneedling in alopecia areata. |
|
Scientific Title of Study
|
A comparison of topical corticosteroids versus topical tacrolimus with microneedling in 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 |
Dishika Goyal |
| Designation |
Postgraduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward no 22, Department of Dermatology, Maulana Azad Medical College,Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi
Central
DELHI
110002
India |
| Phone |
9464630097 |
| Fax |
|
| Email |
goyaldishika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Deb Barman |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No.4, Ward No.22, Department of Dermatology, Maulana Azad Medical College,Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi
Central
DELHI
110002
India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine, 3rd floor, Maulana Azad Medical College,Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi
Central
DELHI
110002
India |
| Phone |
9811656127 |
| Fax |
|
| Email |
prtickle07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, India, 110002. |
|
|
Primary Sponsor
|
| Name |
Dishika Goyal |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Near Delhi Gate, New Delhi, India, 110002. |
| 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 Dishika Goyal |
Lok Nayak Hospital, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi |
Ward no 22, Department of Dermatology
Central
DELHI |
9464630097
goyaldishika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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 |
Topical corticosteroids versus topical tacrolimus with microneedling in alopecia areata |
One half of the scalp receives topical 0.1% tacrolimus ointment application once daily with 4 sessions of microneedling for 3 months. |
| Comparator Agent |
Topical corticosteroids versus topical tacrolimus with microneedling in alopecia areata |
The other half of the scalp receives topical 0.05% betamethasone cream application once daily for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed as alopecia areata.
Patients ≥ 2 patches of hair loss over scalp.
Patients on topical or systemic treatment after washout period of 2 weeks and 4 weeks respectively. |
|
| ExclusionCriteria |
| Details |
Patients with alopecia totalis/ universalis.
Patients with skin atrophy on alopecia patch.
Pregnancy/ lactation.
Active infection.
Patients with comorbidities.
Hemophilias/ bleeding tendency.
Tendency for scarring/ keloid formation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy of topical tacrolimus with microneedling in alopecia areata using SALT score and dermascopy.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative efficacy of topical tacrolimus with microneedling versus topical corticosteroids in alopecia areata. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="1"
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
|
A detailed clinical history will be taken. A thorough general physical and dermatological examination will be carried out in all patients. In selected patients, patches on right side of scalp will be labelled as side A while patches on left side of scalp will be labelled as side B. Side A and Side B would be randomized to receive either topical corticosteroids or topical tacrolimus with 4 sessions of microneedling using computer-based sequence. Assessment will be done by SALT (Severity of Alopecia Tool) score, dermoscopy, photographic record and patient satisfaction score. Side effect documentation (if any) will also be done. All the above evaluation will be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks. |