A study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Facial Wrinkles (Nasolabial Folds).
Phase 1
Completed
- Conditions
- Health Condition 1: null- Facial Wrinkles (Nasolabial Folds)
- Registration Number
- CTRI/2012/05/002627
- Lead Sponsor
- KASIAK RESEARCH PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 investigatorâ??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 â?¢Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest <br/ ><br>â?¢Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading on full smile <br/ ><br>â?¢Global Aesthetic Improvement Scale (GAIS ) <br/ ><br>Timepoint: End of Study - 3 Months
- Secondary Outcome Measures
Name Time Method â?¢Photographic Assessment <br/ ><br>â?¢Physicianâ??s assessment scores <br/ ><br>â?¢Patientâ??s assessment scores <br/ ><br>Timepoint: End of Study - 3 Months