A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
NCT01643629 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
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. The study is being conducted at 2 centers in India. The primary endpoints are 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 (HPL)
Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
- OTHER
-
2 % Minoxidil and /or Finasteride
Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)
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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