Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Arm-A : YTO-459 (without microdermabrasion): Application of YTO-459 on the back of the hand (without microdermabrasion).
Intervention2: Arm-B : YTO-459 with Microdermabrasion: Applicati
Sponsors
Yuvan Research Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of both sexes aged 55 years and above 2. Subjects with fine lines or wrinkles graded as Grade 1 or higher on the Allergan Fine Lines Scale 3. Subjects with mild to moderate crow s feet wrinkles graded as 3 or above on the Modified Anti-Ageing Atlas 6-point scale 4. Subjects willing to participate in the study by providing signed informed consent
Exclusion criteria
Exclusion criteria: 1. Refusal or inability to give informed consent to participate in the study 2. Subjects who have undergone any dermatological or surgical procedure of the hand 3. Subjects who are currently using or have used anti-aging anti-wrinkle Alpha hydroxy acids or retinol-based cosmetics in the past 3 months 4. Participation in or administration of any clinical trials or investigational drugs within 30 days prior to the screening visit 5. History of known bleeding disorders 6. Any relevant or clinically significant condition that may interfere with efficacy or safety assessments during the study drug administration 7. History of drug or alcohol abuse or addiction within the past 5 years 8. Persons under guardianship or those incapable of judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To measure the change in the skin after the study treatment using photometric analysis at the end of the study visit compared to the baseline visit between the treatment groups 2. To measure the change in class of wrinkle after the study treatment according to MFW Scale at the end of the study visit compared to the baseline visit between the treatment groupsTimepoint: Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To measure the reduction of fine lines in the skin after the study treatment using Allergan Fine Lines Scale at the end of the study visit compared to the baseline visit between the treatment groups 2. To measure subject satisfaction after the study treatment using the subject satisfaction questionnaire at the end of the study visit compared to the baseline visit between the treatment groups 3. To measure improvement in the natural look and feel of the skin using Global Aesthetic Improvement Scale GAIS at the end of the study visit compared to the baseline visit between the treatment groups 4. To measure the proportion of participants with treatment emergent adverse events TEAEs leading to study treatment discontinuation between the treatment groups 5. To compare the rate of adverse events between the treatment groupsTimepoint: Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed