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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm A | Other | Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2 |
|
| Control Arm B | Other | Topical Applications of the standard therapy as directed by the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Platelet Lysate | Other | Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Assessment | Day 0, Month 1, Month 2, End of Study - 3 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Physician's assessment scores | End of Study - 3 months | |
| Patient's assessment scores | End of Study - 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Farida Modi, Dr. | Dermacare | Principal Investigator |
| Preeti Savardekar, Dr. | Shree Krishna Polyclinic | Principal Investigator |
| Sharmila Patil, Dr. | Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic | 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
Not provided
| Standard Therapy | Other | Topical Applications as directed by the investigator |
|
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided