A study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Facial Wrinkles (Nasolabial Folds).

Phase 1/2

Completed

• Conditions: Facial Wrinkles (Nasolabial Folds)

• Registration Number: CTRI/2012/05/002627
• Lead Sponsor: KASIAK RESEARCH PRIVATE LIMITED

Brief Summary

This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in  Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and   Global Aesthetic Improvement Scale (GAIS ) . The secondary endpoints are improvement in photographic assessment,   Physician’s assessment scores,  Patient’s assessment scores form enrollment to end of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 2013-10-04

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Subjects (male and female), aged 18 to 40 years (both inclusive).
• 2.Subjects willing to refrain from any other treatment for Nasolabial Folds.
• 3.Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

• 1.Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc 2.Subjects with history of Connective tissue disease 3.
• Subjects with autoimmune diseases 4.
• Subjects unwilling to or unable to comply with the study protocol.
• 5.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest	End of Study - 3 Months
•Global Aesthetic Improvement Scale (GAIS )	End of Study - 3 Months
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile	End of Study - 3 Months

Secondary Outcome Measures

Name	Time	Method
•Photographic Assessment	•Physician’s assessment scores

Trial Locations

Locations (2)

Dr Rachitas Skin Trichology & Aesthetic Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Kapadia Multispeciality Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr Rachitas Skin Trichology & Aesthetic Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Rachita Dhurat

Principal investigator

9870390057

rachitadhurat@yahoo.co.in