A pilot study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Acne Scarring
- Conditions
- Health Condition 1: null- Acne Scarring
- Registration Number
- CTRI/2012/06/002732
- Lead Sponsor
- Kasiak Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Changes in the Global Acne scarring classification scores from screening to end of the study.Timepoint: End of study - 4 Months
- Secondary Outcome Measures
Name Time Method â?¢ Photographic Assessment <br/ ><br>â?¢ Physicianâ??s assessment scores for acne scarring. <br/ ><br>â?¢ Patientâ??s assessment scores for acne scarring. <br/ ><br>Timepoint: End of study - 4 Months