Study to evaluate the safety and efficacy of anti ageing product in healthy adult female subjects with skin type III to V.

Not Applicable

Completed

• Registration Number: CTRI/2013/06/003780
• Lead Sponsor: Sami Labs P Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy of anti-ageing product in impar t ing <br/ ><br>improvement of fine lines and wrinkles in healthy female <br/ ><br>subjects.Timepoint: Day 1, Day 14, day 56

Secondary Outcome Measures

Name	Time	Method
Improvement in skin moisturization and safety of the anti-ageing productTimepoint: Day 1, Day 14, day 56