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

Primary Purpose

ACNE SCARRING

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous Human Platelet Lysate
Autologous Human Platelet Lysate
Sponsored by
Kasiak Research Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACNE SCARRING

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasiak Research Pvt Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Study arm A

Study arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in the Global Acne scarring classification

Secondary Outcome Measures

Photographic Assessment

Full Information

First Posted
July 17, 2012
Last Updated
October 12, 2012
Sponsor
Kasiak Research Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01644435
Brief Title
A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kasiak Research Pvt. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACNE SCARRING

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm A
Arm Type
Other
Arm Description
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Arm Title
Study arm B
Arm Type
Other
Arm Description
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate
Intervention Description
Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Intervention Type
Biological
Intervention Name(s)
Autologous Human Platelet Lysate
Intervention Description
Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring
Primary Outcome Measure Information:
Title
Changes in the Global Acne scarring classification
Time Frame
Day 0, End of study - Month 3
Secondary Outcome Measure Information:
Title
Photographic Assessment
Time Frame
Day 0, Month 1, Month 2 End of study - Month 3
Other Pre-specified Outcome Measures:
Title
Physician's assessment scores
Time Frame
End of Study - Month 3
Title
Patient's assessment scores
Time Frame
End of Study - Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmila Patil, Dr.
Organizational Affiliation
Dermocosmetic laser center hair and skin clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pankaj Maniar, Dr.
Organizational Affiliation
Radiance Cosmetology Clinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasiak Research Pvt Ltd
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
400610
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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