None listed
Conditions
Interventions
Intervention1: Anti-aging cream: 3 Visits - Week 0 (Day 01), Week 2 (Day 14 - Compliance visit) and Week 8(Day 56), instrument and dermatologist evaluation, Twice application of the cream daily for 56
Sponsors
Sami Labs P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Female adult subjects in general good health as determined from a recent medical history. 2. Subjects in the age group of 30 - 50 years (both ages inclusive). 3. Subjects with Fitzpatrickâ??s skin types III, IV, and V. 4. Subjects having visible fine lines and wrinkles, i.e, Glabellar frownlines/Crowâ??s feet/nasolabial folds/forehead lines and perioral wrinkles or few or all of them. 5. Subjects who have not under gone any facial anti ageing procedures (e.g. Botulinum toxin, dermal filler injections, laser resurfacing) in the past 1 year. 6. Subjects willing to discontinue use of topical anti ageing products within 30 days before enrolling into study and not on any oral anti ageing products such as anti oxidants, green tea, etc 3 months before enrollment into study. 7. Subject who are willing to abstain from spa treatments/facials during the study Period. 8. Subjects who have not undergone facial/spa treatment 2 weeks before enrollment. 9. Subjects willing to give a voluntary written informed consent and agree to come for regular follow up. 10. Subjects willing to abide by and comply with the study protocol. 11. Subjects who have not participated in a similar investigation in the past four weeks. 12. Subjects who are willing not to participate in any other clinical study during participation in the current study. 13. In addition, female subjects selected for the study must: • Be using a medically acceptable form of birth control for the duration of the study as judged by the investigator(s) Or • Be surgically sterile Or • Be post menopausal for at least 1 year • And have a negative urine pregnancy test at the screening visit
Exclusion criteria
Exclusion criteria: 1.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients,pharmaceutical products or any ingredient of the IP. 2. Female subjects with positive pregnancy test or not practicing contraception and nursing mothers. 3. History of intense sun exposure. 4. Presence of any underlying, clinically significant uncontrolled medical illness. 5. Subject having active skin diseases 6. Subject participating in any other cosmetic or therapeutic study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of anti-ageing product in impar t ing improvement of fine lines and wrinkles in healthy female subjects.Timepoint: Day 1, Day 14, day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in skin moisturization and safety of the anti-ageing productTimepoint: Day 1, Day 14, day 56 | — |
Countries
India
Contacts
Public ContactDr Rachana Shilpakar
MS Clinical Research Pvt. Ltd
Outcome results
None listed