Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm A | Other | Subjects will receive hair follicles transplants that are dipped in HPL before transplant |
|
| Study arm B | Other | Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant |
|
| Control arm C | Other | Subject will receive Standard hair follicle transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Platelet Lysate | Biological | Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Calibre & Density of Hair as assessed by Folliscope | Day 0, Month 2, End of Study - Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic assessment | Day 0, Month 1, Month 2, Month 3, End of Study - Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's assessment score | End of Study - Month 4 | |
| Patient's self assessment score | End of Study - Month 4 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rajendarsingh Rajput, Dr. | Dr. Rajesh Rajput Hair Restore | Principal Investigator |
| Sandeep Sattur, Dr. | Hairrevive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasiak Research Pvt Ltd | Thane | Maharashtra | 400610 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Autologous Human Platelet Lysate | Biological | Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection |
|
| Standard hair follicle transplant | Other | Control arm subject will receive Standard hair follicle transplant |
|
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided