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A pilot study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Acne Scarring

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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002732
Enrollment
20
Registered
2012-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acne Scarring

Interventions

Intervention1: Autologous Human Platelet Lysate (HPL): Subjects will receive a single injection of Autologous Human Platelet Lysate (5ml) for acne scarring. Intervention2: Autologous Human Platelet Ly

Sponsors

Kasiak Research Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects (male and female), aged 18 to 40 years (both inclusive). 2. Subject willing to refrain from any other treatment of Acne Scarring during entire study duration. 3. Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study. 4. Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects with active infection or active acne. 2. Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study. 3. Subjects with history of connective tissue disease. 4. Subjects with metabolic or hematopoietic disorders. 5. Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia. 6. Subjects who have received prior chemotherapy and radiotherapy 7. Subjects unwilling to or unable to comply with the study protocol. 8. Subjects taking concomitant therapy that might interfere with the study results in the investigatorâ??s opinion or participating in another trial in the past 30days

Design outcomes

Primary

MeasureTime frame
â?¢Changes in the Global Acne scarring classification scores from screening to end of the study.Timepoint: End of study - 4 Months

Secondary

MeasureTime frame
â?¢ Photographic Assessment â?¢ Physicianâ??s assessment scores for acne scarring. â?¢ Patientâ??s assessment scores for acne scarring. Timepoint: End of study - 4 Months

Countries

India

Contacts

Public ContactDr Kaushal Shah

Dermocosmetic laser center hair and skin clinic

drsharmilapatil@gmail.com022-25405537

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026