A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- •Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
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
- •Subjects with autoimmune diseases
- •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.
Outcomes
Primary Outcomes
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest
Time Frame: End of Study - 3 Months
•Global Aesthetic Improvement Scale (GAIS )
Time Frame: End of Study - 3 Months
•Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile
Time Frame: End of Study - 3 Months
Secondary Outcomes
- •Photographic Assessment(•Physician’s assessment scores)