Periorbital Hyperpigmentation (Dark Circles)
Conditions
Brief summary
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.
Interventions
Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
OTHERStandard Therapy
Topical Applications as directed by the investigator
Sponsors
Kasiak Research Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation. * Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration. * Subjects who are willing to give informed consent and adhere to the study protocol.
Exclusion criteria
* Subjects aged less than 18 and more than 55 years * Subjects with history of connective tissue disease. * Subjects with metabolic or hematopoietic disorders * Subjects unwilling to or unable to comply with the study protocol. * Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Photographic Assessment | Day 0, Month 1, Month 2, End of Study - 3 months |
Other
| Measure | Time frame |
|---|---|
| Physician's assessment scores | End of Study - 3 months |
| Patient's assessment scores | End of Study - 3 months |
Countries
India
Outcome results
None listed