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A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
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.
Details
| Lead sponsor | Kasiak Research Pvt. Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 30 |
| Start date | 2012-01 |
| Completion | 2012-11 |
Conditions
- Androgenetic Alopecia
Interventions
- Autologous Human Platelet Lysate
- Autologous Human Platelet Lysate
- Standard hair follicle transplant
Primary outcomes
- Improvement in Calibre & Density of Hair as assessed by Folliscope — Day 0, Month 2, End of Study - Month 4
Countries
India