Injectable platelet rich fibrin in androgenetic alopecia ( Patterened baldness)

Phase 3

Recruiting

Conditions: Androgenic alopecia, unspecified,

Registration Number: CTRI/2023/08/056292

Lead Sponsor: Dr Sahana N C

Brief Summary: Androgenetic alopecia (AGA), also known as male or female pattern hair loss, is one of the most common chronic progressive hair loss. Itâ€™s an androgen dependent and genetically mediated disorder affecting 50% of the population.

In AGA there is progressive involvement of frontal, temporal, midscalp and vertex region

in males and incomplete involvement of these regions with preservance of frontal hairline in females. AGA is a significant stressor and a major cause of low self-esteem and depression.

The utility of platelet-rich plasma (PRP) has spanned various fields of dermatology.

Injectable-PRF is considered the third generation of platelet concentrates possessing a higher and longer release of a variety of growth factors, cytokines and a delicate three-dimensional scaffold structure. Itâ€™s developed by modifying spin centrifugation forces based on low speed centrifugation concept (LSCC).5

PRF induces differentiation of stem cells, prolongs survival of dermal papillary cells, prolongs the anagen phase of the hair cycle, increases perifollicular vascular plexus by multiple mechanisms through various growth factors. i-PRF is a simple, less time consuming, cost effective method which need further evaluation in androgenetic alopecia.

METHODOLOGY

After obtaining approval and clearance from the institutional ethics committee, the patients with androgenetic alopecia fulfilling the inclusion criteria and willing to give informed consent will be enrolled in the study.

Details regarding the symptoms, duration, site, family history, precipitating factor and previous treatments if any will be recorded. Global photography of scalp will be taken before and after the treatment and at the end of follow- up period. Trichoscopy will be done in an area of 1 cm2 marked. A metric tape measure graduated in centimeters will be used to mark the square centimeter and the longitudinal distance from the corresponding end of the eyebrow or nasal root. The image of the area will then be amplified using a trichoscope and photographs will be taken before each injection.

10-40 ml of blood will be collected and filled in plain vacutainer tubes (without an anti-coagulant) of 5 ml each and will be centrifuged immediately at 700 rotations per minute for 3 minutes using a REMI-R8C centrifuge machine.

The i-PRF (yellow-reddish liquid) formed at the upper part of the tube will be collected using 31G insulin syringes and injected at a distance of 1cm each entering a depth of 2-4 mm on the entire scalp.

All patients will be on a background therapy of 5% minoxidil solution, oral finasteride 1 mg per day and multivitamin supplements.

Four sitting at 2 weekly intervals will be done and patient will be followed up for 3 months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 15

Inclusion Criteria

Patients willing to give informed consent 2.
Patients of either gender aged 18 to 60 years.
Androgenetic Alopecia in males with Norwood-Hamilton grade 2-6 and females beyond grade 1 according to Ludwigâ€™s scale.
Patients willing for follow up.

Exclusion Criteria

patients with Alopecia other than Androgenetic Alopecia 2.
Patients with active infection at the local site 3.
Patients with keloidal tendency 4.
Patients with blood coagulopathies and platelets count below 1,50,000cell/mm3 5.
Pregnant and lactating mothers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trichoscopic improvement/ maintenance in the hair density / diameter	4 sessions at 2 weekly intervals \| Final assessment at the end of 3 months

Secondary Outcome Measures

Name	Time	Method
Improvements in visual analogue scale	Improvements in global photography

Trial Locations

Locations (1): Victoria hospital, Bangalore medical college and research institute
🇮🇳
Bangalore, KARNATAKA, India
Victoria hospital, Bangalore medical college and research institute
🇮🇳Bangalore, KARNATAKA, India
Dr Sahana N C
Principal investigator
9449998099
bhatt.sahana5@gmail.com