CTRI/2024/01/062101CompletedPhase 4
Spirinolactone versus Bicalatumide in female pattern hair loss; a randomised clinical trial
Abhijeet Kumar Jha1 site in 1 country200 target enrollmentStarted: December 2, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Increase in hair density in 200 patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Treatment naive Grade 2-5 Female Pattern Hair loss.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Increase in hair density in 200 patients
Time Frame: 24 weeks
Adverse effects in 200 patients
Time Frame: 24 weeks
Secondary Outcomes
- Increase in hair density in 200patients(Averse effects in 200 patients)
Investigators
Study Sites (1)
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