ACNE SCARRING
Conditions
Brief summary
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.
Interventions
BIOLOGICALAutologous Human Platelet Lysate
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Sponsors
Kasiak Research Pvt. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects (male and female), aged 18 to 40 years (both inclusive). * Subject willing to refrain from any other treatment of Acne Scarring during entire study duration. * Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study. * Subjects who are willing to give informed consent and adhere to the study protocol.
Exclusion criteria
* Subjects with active infection or active acne. * Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study. * Subjects with history of connective tissue disease. * Subjects with metabolic or hematopoietic disorders. * Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia. * Subjects who have received prior chemotherapy and radiotherapy * 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 30days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Global Acne scarring classification | Day 0, End of study - Month 3 |
Secondary
| Measure | Time frame |
|---|---|
| Photographic Assessment | Day 0, Month 1, Month 2 End of study - Month 3 |
Other
| Measure | Time frame |
|---|---|
| Physician's assessment scores | End of Study - Month 3 |
| Patient's assessment scores | End of Study - Month 3 |
Countries
India
Outcome results
None listed