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NCT Number: NCT01644435

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

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Key information

Conditions

Acne Scarring

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Human Platelet Lysate

Biological

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

Primary outcomes

  1. Changes in the Global Acne scarring classification

    Time frame: Day 0, End of study - Month 3

Secondary outcomes

  1. Photographic Assessment

    Time frame: Day 0, Month 1, Month 2 End of study - Month 3

Other outcomes

  1. Physician's assessment scores

    Time frame: End of Study - Month 3

  2. Patient's assessment scores

    Time frame: End of Study - Month 3

Sponsors and collaborators

Lead sponsor

Kasiak Research Pvt. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2012
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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