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

Periorbital Hyperpigmentation (Dark Circles) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01644448
• Other study ID #: KRPL/HPL-FR/11-12/002A
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 17, 2012
• Last updated: July 24, 2012
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Kasiak Research Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperpigmentation
• Periorbital Hyperpigmentation (Dark Circles)

Intervention

Other:
• Autologous Human Platelet Lysate
Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
• Standard Therapy
Topical Applications as directed by the investigator

Locations

Country	Name	City	State
India	Kasiak Research Pvt Ltd	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Kasiak Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician's assessment scores		End of Study - 3 months	No
Other	Patient's assessment scores		End of Study - 3 months	No
Primary	Photographic Assessment		Day 0, Month 1, Month 2, End of Study - 3 months	No