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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm A | Other | Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each. |
|
| Control Arm B | Other | Control arm B will include subjects receiving Standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Platelet Lysate (HPL) | Biological | Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Calibre & Density of Hair as assessed by Folliscope | Day 0, Month 4, End of study - Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Assessment | Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Assessment Score | End of study - Month 6 | |
| Patient's Assessment Score | End of study - Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| 2 % Minoxidil and /or Finasteride | Other | Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride) |
|
| 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 |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
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