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

NCT01644435 | Completed Phase 1 DMC

• 1 other identifier: KRPL/HPL-AS/11-12/004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

ACNE SCARRING

Outcome Measures

Primary Outcomes (1)

• Changes in the Global Acne scarring classification

  Day 0, End of study - Month 3

Secondary Outcomes (1)

• Photographic Assessment

  Day 0, Month 1, Month 2 End of study - Month 3

Other Outcomes (2)

• Physician's assessment scores

  End of Study - Month 3

• Patient's assessment scores

  End of Study - Month 3

Study Arms (2)

Study arm A

OTHER

Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring

Biological: Autologous Human Platelet Lysate

Study arm B

OTHER

Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.

Biological: Autologous Human Platelet Lysate

Interventions

Autologous Human Platelet Lysate BIOLOGICAL

Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring

Study arm A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.: lead

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Location

Study Officials

• Sharmila Patil, Dr.

  Dermocosmetic laser center hair and skin clinic

  PRINCIPAL INVESTIGATOR

• Pankaj Maniar, Dr.

  Radiance Cosmetology Clinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

IN (1)