| CTRI Number |
CTRI/2026/01/101257 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Randomized Comparative Study of Topical Minoxidil 5%, Low-Dose Oral Minoxidil, and Topical Minoxidil Combined with Oral Spironolactone in Female Pattern Hair Loss |
|
Scientific Title of Study
|
EFFICACY AND SAFETY OF TOPICAL MINOXIDIL 5 PERCENT ALONE VERSUS ORAL MINOXIDIL VERSUS TOPICAL MINOXIDIL 5 PERCENT WITH ORAL SPIRONOLACTONE IN FEMALE PATTERN HAIR LOSS : A RANDOMISED CLINICAL COMPARATIVE 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 |
Sreya Sibbadi |
| Designation |
Post Graduate Student |
| Affiliation |
IMS & SUM Hospital |
| Address |
Department of DVL, IMS and SUM Hospital.
Department of DVL, IMS and SUM Hospital
Khordha
ORISSA
751029
India |
| Phone |
09769804945 |
| Fax |
|
| Email |
sreyasvisibbadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajaya Kumar Jena |
| Designation |
PROFESSOR |
| Affiliation |
IMS & SUM Hospital |
| Address |
IMS and SUM Hospital, Department of DVL
IMS and SUM Hospital, Department of DVL
Khordha
ORISSA
751029
India |
| Phone |
09769804945 |
| Fax |
|
| Email |
ajayajenabbsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreya Sibbadi |
| Designation |
Post Graduate Student |
| Affiliation |
IMS & SUM Hospital |
| Address |
IMS and SUM Hospital, Department of DVL
IMS and SUM Hospital, Department of DVL
Khordha
ORISSA
751029
India |
| Phone |
09769804945 |
| Fax |
|
| Email |
sreyasvisibbadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM Hospital, Department of DVL,K8, Kalinganagar, Bhubaneswar, 751003 |
|
|
Primary Sponsor
|
| Name |
IMS SUM Hospital |
| Address |
Department of DVL IMS and SUM Hospital K8 Kalinga Nagar Bhubaneshwar 751003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sreyasvi Rao Sibbadi |
IMS & SUM Hospital |
IMS and SUM Hospital, Department of DVL, Ground floor
Khordha
ORISSA |
9769804945
sreyasvisibbadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS & SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORAL MINOXIDIL |
To give low dose minoxidil (1.25mg), daily once orally for 6 months |
| Intervention |
ORAL SPIRONOLACTONE WITH TOPICAL MINOXIDIL 5 percent |
To give 25mg of tablet spironolactone orally twice daily along with 5 percent topical minoxidil to apply over the scalp once daily for 6 months |
| Comparator Agent |
Topical minoxidil 5 percent |
To compare with topical minoxidil 5 percent once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All females aged between 18-45 years with female pattern hair loss; Ludwig scale II- III.
2. Any females who completed 4 months of therapy.
|
|
| ExclusionCriteria |
| Details |
1.Any relative contraindications to oral spironolactone; such as insufficiency of heart, liver, kidney, low blood pressure or elevated blood potassium levels.
2.Any relative contraindications to oral minoxidil; such as any history of bleeding disorders, use of anticoagulants or active infection at the targeted area.
3.Use of topical or systemic medications that influence hair growth within the last 6 months
4.Pregnancy and lactation.
5.Patients planning to conceive within a year
6.Presence of any other forms of alopecia (alopecia areata, frontal fibrosing alopecia, telogen effluvium)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss
To assess the safety of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
26/01/2026 |
| 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
|
This randomized comparative clinical trial
evaluates the efficacy and safety of three treatment regimens for Female
Pattern Hair Loss (FPHL): topical minoxidil 5% alone, topical minoxidil plus
low-dose oral minoxidil, and topical minoxidil plus oral spironolactone. FPHL
is a common, progressive condition with limited long-term results from topical
minoxidil monotherapy, and evidence for combination therapy—especially dual
minoxidil therapy—remains insufficient. After obtaining consent, eligible
patients undergo baseline history, Ludwig grading, global assessments,
standardized scalp photography, dermoscopic evaluation of a tattoo-marked
target area, and baseline ECG, serum potassium, and blood pressure recording.
Participants are randomized into three groups and followed at 4, 8, 16, and 24
weeks for repeat dermoscopic measurements, physician and patient global
assessments, hair density and shaft diameter evaluation, and safety monitoring.
This study aims to determine whether combined topical and oral minoxidil offers
superior outcomes, potentially providing a more effective therapeutic option
for women with FPHL |