A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles

NCT01644448 | Unknown Phase 1 DMC

• 1 other identifier: KRPL/HPL-FR/11-12/002A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.

Conditions

Periorbital Hyperpigmentation (Dark Circles)

Outcome Measures

Primary Outcomes (1)

• Photographic Assessment

  Day 0, Month 1, Month 2, End of Study - 3 months

Other Outcomes (2)

• Physician's assessment scores

  End of Study - 3 months

• Patient's assessment scores

  End of Study - 3 months

Study Arms (2)

Study arm A

OTHER

Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2

Other: Autologous Human Platelet Lysate

Control Arm B

OTHER

Topical Applications of the standard therapy as directed by the investigator

Other: Standard Therapy

Interventions

Autologous Human Platelet Lysate OTHER

Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2

Study arm A

Standard Therapy OTHER

Topical Applications as directed by the investigator

Control Arm B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
• Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
• Subjects who are willing to give informed consent and adhere to the study protocol.

You may not qualify if:

• Subjects aged less than 18 and more than 55 years
• Subjects with history of connective tissue disease.
• Subjects with metabolic or hematopoietic disorders
• 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 30 days.

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.: lead

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Farida Modi, Dr.

  Dermacare

  PRINCIPAL INVESTIGATOR

• Preeti Savardekar, Dr.

  Shree Krishna Polyclinic

  PRINCIPAL INVESTIGATOR

• Sharmila Patil, Dr.

  Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

IN (1)