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Trial record 26 of 82 for:    acne AND Acne Scars

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

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ClinicalTrials.gov Identifier: NCT01644435
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.

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.

Condition or disease Intervention/treatment Phase
ACNE SCARRING Biological: Autologous Human Platelet Lysate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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

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 two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring




Primary Outcome Measures :
  1. Changes in the Global Acne scarring classification [ Time Frame: Day 0, End of study - Month 3 ]

Secondary Outcome Measures :
  1. Photographic Assessment [ Time Frame: Day 0, Month 1, Month 2 End of study - Month 3 ]

Other Outcome Measures:
  1. Physician's assessment scores [ Time Frame: End of Study - Month 3 ]
  2. Patient's assessment scores [ Time Frame: End of Study - Month 3 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644435


Locations
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India
Kasiak Research Pvt Ltd
Thane, Maharashtra, India, 400610
Sponsors and Collaborators
Kasiak Research Pvt. Ltd.
Investigators
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Principal Investigator: Sharmila Patil, Dr. Dermocosmetic laser center hair and skin clinic
Principal Investigator: Pankaj Maniar, Dr. Radiance Cosmetology Clinique

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Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01644435     History of Changes
Other Study ID Numbers: KRPL/HPL-AS/11-12/004
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes