Trial | NCT01644435  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    platelet-rich plasma ...

  • Study Participants

    19
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 Started
May 31
2012
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Oct 15
2012
Estimate

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

Study arm A Other

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

Study arm B Other

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

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
No Results Posted