A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kasiak Research Pvt. Ltd.
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Changes in the Global Acne scarring classification
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Study arm A
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Intervention: Autologous Human Platelet Lysate (Biological)
Study arm B
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.
Intervention: Autologous Human Platelet Lysate (Biological)
Outcomes
Primary Outcomes
Changes in the Global Acne scarring classification
Time Frame: Day 0, End of study - Month 3
Secondary Outcomes
- Photographic Assessment(Day 0, Month 1, Month 2 End of study - Month 3)