| CTRI Number |
CTRI/2025/09/094032 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study to evaluate efficacy and safety of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata. |
|
Scientific Title of Study
|
An open label non randomised comparative interventional study to evaluate efficacy and safety of 2% Crisaborole ointment versus 0.05% Clobetasol propionate ointment in mild alopecia areata at a tertiary care centre |
| 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 Priyanka Deshapnde |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Dermatology, Venerology, Leprosy, Jawaharlal Nehru Medical College Belagavi 590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
09819647785 |
| Fax |
|
| Email |
priyankadeshpande9798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar K Patil |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Dermatology, Venerology, Leprosy, Jawaharlal Nehru Medical College Belagavi 590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
09819647785 |
| Fax |
|
| Email |
shivakumarkpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Deshapnde |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Dermatology, Venerology, Leprosy, Jawaharlal Nehru Medical College Belagavi 590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
09819647785 |
| Fax |
|
| Email |
priyankadeshpande9798@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Deshpande |
| Address |
Department of Dermatology, Venerology, Leprosy, Jawaharlal Nehru Medical College Belagavi 590010 Karnataka |
| 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 Priyanka Deshapnde |
KLEs Dr Prabhakar Kore hospital |
OPD no 23, 1st floor Dept of Dermatology, Venerology and Leprosy Jawaharlal Nehru Medical college belagavi Karnataka
Belgaum
KARNATAKA |
09819647785
priyankadeshpande9798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
0.05 % clobetasol propionate topical cream application |
patients are adviced to apply a thin layer of ointment on the alloted patch of hairloss twice daily for a total duration of 3 months |
| Comparator Agent |
2% crisaborole ointment |
patients are adviced to apply the cream twice daily over the alloted patch of hairloss for a total duration of 3 months |
| Intervention |
topical cream |
topical creams will be applied twice daily over the hairloss patch for a total duration of 3 months and results will be compared with the baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients between age eighteen to sixty years with more than one patch of alopecia areata. |
|
| ExclusionCriteria |
| Details |
1. Alopecia totalis, Alopecia universalis
2. conditions with other types of hairloss like frontal fibrosing alopecia, DLE, trichotillomania.
3. pregnant and breastfeeding females.
4. currently on oral PDE4 or JAK inhibitor
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety of 2% crisaborole ointment versus 0.05% clobetasol propionate ointment in mild alopecia areata. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/10/2025 |
| 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
|
•All patients of age group 18 to 60 years with
clinically diagnosed cases of Alopecia Areata, with one than one patch of hair
loss attending Kle’s Dr. Prabhakar Kore Hospital will be chosen.
•Informed consent will be taken from all the patients
included in the study.
•All patients will undergo a detailed history taking,
general, physical, systemic and dermatological examination.
•Data will be collected by a single examiner and
recorded in case record proforma.
•Patients will be explained in terms of the treatment
offered in terms of expected results, duration of treatment, follow-ups, side
effects to be reported and prognosis of the treatment.
•Digital photographs from all sides of the scalp will
be taken using identical camera settings, patients positioning and room
lighting at baseline and at every sitting. •INTERVENTION DONE - The patients
are given topical 2% Crisaborole ointment
twice daily application on one patch and
0.05% Clobetasol propionate ointment twice daily on another patch.
•The patients will be called after 1 month to assess
the effectiveness of both topical medications and change from the baseline
•The patients are called after every month for a total
period of 3 months.
•After 3 months, digital photographs will be compared
with that at the baseline.
•Physicians
assessment of improvement will be done by alopecia areata physician
global assessment score.
•Patients assessment of improvement will be recorded by
VISUAL ANALOG SCALE.
•The efficacy of treatment will be calculated based on
percentage of hair regrowth.
•The safety of treatment will be assessed by the side
effects associated with the treatment. |