| CTRI Number |
CTRI/2024/01/062101 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Spirinolactone versus Bicalatumide in female pattern hair loss |
|
Scientific Title of Study
|
Spirinolactone versus Bicalatumide in female pattern hair loss; a randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna Medical College |
| Address |
Department of Skin and VD, Skin OPD, Room no 1, Patna medical college
Patna
BIHAR
800004
India |
| Phone |
09631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna Medical College |
| Address |
Department of Skin and VD, Skin OPD, Room no 1, Patna medical college
Patna
BIHAR
800004
India |
| Phone |
09631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijeet Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Patna Medical College |
| Address |
Department of Skin and VD, Skin OPD, Room no 1, Patna medical college
Patna
BIHAR
800004
India |
| Phone |
09631444797 |
| Fax |
|
| Email |
drabhijeetjha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patna Medical College and Hospital, Patna, Bihar |
|
|
Primary Sponsor
|
| Name |
Abhijeet Kumar Jha |
| Address |
Department of Skin and VD |
| Type of Sponsor |
Government medical college |
|
|
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 Abhijeet Kumar Jha |
Patna Medical College |
Department of Skin and VD, Skin OPD, Room no 1, Patna Medical College, Ashok Rajpath, Patna
Patna
BIHAR |
9631444797
drabhijeetjha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patna Medical College Patna, Ashok Rajpath, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L648||Other androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bicalatumide |
Dose-50mg OD (Once daily)
Duration-24 weeks
Route of administration-Oral |
| Comparator Agent |
Spirinolactone |
Dose-100mg OD (Once daily)
Duration-24 weeks
Route of administration-Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Treatment naive
Grade 2-5 Female Pattern Hair loss |
|
| ExclusionCriteria |
| Details |
Nursing and pregnant females
History of topical minoxidil application
History of malignancy
History of any SSRI, antihypertensive, potassium supplement
Any other hormonal therapy, oral contraceptive pills |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in hair density in 200 patients
Adverse effects in 200 patients
|
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increase in hair density in 200patients
Averse effects in 200 patients |
4 weeks,8 weeks,12 weeks,16 weeks, 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "196"
Final Enrollment numbers achieved (India)="196" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/02/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Female Pattern hair loss is characterised by decreased scalp hair density and progressive miniaturization of hair. follicles. Aims: To compare safety and efficacy of Spirinolactone versus Bicalatumide in Female Pattern Hair Loss [FPHL] Methods: All eligible female aged18 to 50 years with grade 2-5 Sinclair grade of FPHL will be recruited by randomisation. All treatment naive cases will be included. Global photographic assessment along with trichoscopic images will be captured at each follow up to study any change in hair density and number at each 4 week follow up.
|