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
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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