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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 (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.
Details
| Lead sponsor | Kasiak Research Pvt. Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 20 |
| Start date | 2012-03 |
| Completion | 2012-11 |
Conditions
- Periorbital Hyperpigmentation (Dark Circles)
Interventions
- Autologous Human Platelet Lysate
- Standard Therapy
Primary outcomes
- Photographic Assessment — Day 0, Month 1, Month 2, End of Study - 3 months
Countries
India