A comaprative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Dark Circles

Phase 1/2

Completed

• Conditions: Periorbital Hyperpigmentation (Dark Circles)

• Registration Number: CTRI/2012/04/002549
• Lead Sponsor: KASIAK RESEARCH PRIVATE LIMITED

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• 1.Subjects aged less than 18 and more than 55 years 2.Subjects with history of connective tissue disease.
• Subjects with metabolic or hematopoietic disorders 4.
• 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Patient’s assessment scores	End of Study - 3Months
•Physician’s assessment scores	End of Study - 3Months

Secondary Outcome Measures

Name	Time	Method
•Photographic assessments	End of Study - 3 Months

Trial Locations

Locations (2)

Derma Care Skin Clinic and Cosmetic Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Shree Krishna Polyclinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Derma Care Skin Clinic and Cosmetic Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Farida Modi

Principal investigator

faridasm@yahoo.com