Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant

NCT01644422 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-07-25

No results posted yet for this study

Summary

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.

Conditions

Interventions

BIOLOGICAL

Autologous Human Platelet Lysate

Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant

BIOLOGICAL

Autologous Human Platelet Lysate

Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection

OTHER

Standard hair follicle transplant

Control arm subject will receive Standard hair follicle transplant

Sponsors & Collaborators

  • Kasiak Research Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rajendarsingh Rajput, Dr. · Dr. Rajesh Rajput Hair Restore

  • Sandeep Sattur, Dr. · Hairrevive

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644422 on ClinicalTrials.gov