A Pilot Study to Determine Safety & 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

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 Overview

• Status: Completed
• Conditions: ACNE SCARRING
• Intervention / Treatment: Biological: Autologous Human Platelet Lysate; Biological: Autologous Human Platelet Lysate

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Thane, Maharashtra, India, 400610
      • Kasiak Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Study arm A; Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring	Biological: Autologous Human Platelet Lysate; Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring; Biological: Autologous Human Platelet Lysate; Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring
OTHER: Study arm B; Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.	Biological: Autologous Human Platelet Lysate; Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring; Biological: Autologous Human Platelet Lysate; Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the Global Acne scarring classification	Day 0, End of study - Month 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Photographic Assessment	Day 0, Month 1, Month 2 End of study - Month 3

Other Outcome Measures

Outcome Measure	Time Frame
Physician's assessment scores	End of Study - Month 3
Patient's assessment scores	End of Study - Month 3

Collaborators and Investigators

• Sponsor: Kasiak Research Pvt. Ltd.
• Investigators: Principal Investigator: Sharmila Patil, Dr., Dermocosmetic laser center hair and skin clinic; Principal Investigator: Pankaj Maniar, Dr., Radiance Cosmetology Clinique

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (ESTIMATE): July 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: KRPL/HPL-AS/11-12/004