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EFFICACY AND TOLERABILITY OF INTRADERMAL INJECTION BICALUTAMIDE IN COMPARISON WITH INTRADERMAL PLATELET RICH PLASMA (PRP) ON SCALP IN THE TREATMENT OF FEMALE PATTERN HAIR LOSS (FPHL) FEMALES ON 5% MINOXIDIL SOLUTION-A RANDOMIZED CLINICAL STUDY

EFFICACY AND TOLERABILITY OF INTRADERMAL INJECTION BICALUTAMIDE IN COMPARISON WITH INTRADERMAL PLATELET RICH PLASMA (PRP) ON SCALP IN THE TREATMENT OF FEMALE PATTERN HAIR LOSS (FPHL) FEMALES ON 5% MINOXIDIL SOLUTION: A RANDOMIZED CLINICAL STUDY - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109237
Enrollment
24
Registered
2026-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L649- Androgenic alopecia, unspecified

Interventions

Intervention1: INTRADERMAL INJECTION: Group A- Intradermal Injection Bicalutamide 0.5% Participants will receive Injection Bicalutamide once monthly for 3 months. 1 ml of Injection Bicalutamide 0

Sponsors

Krishna Vishwa Vidyapeeth (Deemed to be University), karad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria- Have given written consent before any treatment is commenced. Be diagnosed to be suffering from female patterned hair loss by assessment through LUDWIG scale clinically in dermatology OPD Have completed 18 years of age to 65 yrs of age Hair loss severity -women with grade 1 and 2 hair loss , as defined by Ludwig scale Women with polycystic ovarian syndrome (PCOS) not on hormonal therapy

Exclusion criteria

Exclusion criteria: Exclusion criteria- Following patient will be excluded from study- A. Age: Women under 18 years or over 65 years. B. Pregnancy or Lactation: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. C. Hormonal Imbalance: Women with hormonal imbalances, such as polycystic ovary syndrome (PCOS) on hormonal therapy, thyroid disorders, or adrenal disorders. D. Patient having keloid scaring or keloidal tendency. E. History of bleeding disorder and anticoagulant therapy. F. Oral steroid therapy. G. Active skin infection like warts, herpes and bacterial infection. H. Patient on any other systemic drugs therapy which in the judgement of investigator may interfere with interpretation of results.

Design outcomes

Primary

MeasureTime frame
1.Change in hair density from baseline,4weeks ,8weeks, 12weeks,20weeks 2. change in hair thickness from baseline ,4weeks ,8weeks, 12weeks,20weeksTimepoint: 1.Change in hair density from baseline ,4weeks ,8weeks, 12weeks,20weeks 2. change in hair thickness from baseline ,4weeks ,8weeks, 12weeks,20weeks

Secondary

MeasureTime frame
Secondary Outcome Variables Hair Growth Rate- Change in hair growth rate (mm/month) monthly from baseline to 6 months . Anagen/Telogen Ratio- Change in anagen/telogen ratio monthly from baseline to 6 months . Patient-Reported Outcomes- Changes in patient-reported outcomes, such as hair growth satisfaction, hair loss severity, & quality of life. Safety Assessments- Incidence & severity of adverse events, such as injection site reactions, allergic reactions & hormonal changes. Timepoint: monthly

Countries

India

Contacts

Public ContactDr Varsha Jamale

Krishna Vishwa Vidyapeeth (Deemed to be University), Karad

jamalevarsha@gmail.com9822572887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026