A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring

ACNE SCARRING Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644435
• Other study ID #: KRPL/HPL-AS/11-12/004
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 17, 2012
• Last updated: October 12, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Kasiak Research Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACNE SCARRING
• Cicatrix

Intervention

Biological:
• Autologous Human Platelet Lysate
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
• Autologous Human Platelet Lysate
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring

Locations

Country	Name	City	State
India	Kasiak Research Pvt Ltd	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Kasiak Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician's assessment scores		End of Study - Month 3	No
Other	Patient's assessment scores		End of Study - Month 3	No
Primary	Changes in the Global Acne scarring classification		Day 0, End of study - Month 3	No
Secondary	Photographic Assessment		Day 0, Month 1, Month 2 End of study - Month 3	No