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

A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)

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.

Study Overview

• Status: Unknown
• Conditions: Periorbital Hyperpigmentation (Dark Circles)
• Intervention / Treatment: Other: Autologous Human Platelet Lysate; Other: Standard Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Thane, Maharashtra, India, 400610
      • Kasiak Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Study arm A; 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; Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
OTHER: Control Arm B; Topical Applications of the standard therapy as directed by the investigator	Other: Standard Therapy; Topical Applications as directed by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Photographic Assessment	Day 0, Month 1, Month 2, End of Study - 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Physician's assessment scores	End of Study - 3 months
Patient's assessment scores	End of Study - 3 months

Collaborators and Investigators

• Sponsor: Kasiak Research Pvt. Ltd.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2012
• Study Completion (ANTICIPATED): November 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (ESTIMATE): July 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: KRPL/HPL-FR/11-12/002A