To evaluate the anti-aging efficacy of the products in healthy human volunteers

Phase 2

Completed

• Registration Number: CTRI/2018/12/016533
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-21
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Subject is willing to give a written informed consent

2.Subject is a healthy adult male and female in the age range of 35-60 years

3.Subjects with mild to moderate wrinkle crowââ?¬•s feet on scale 3 and above, referring to the Modified Anti-Ageing Atlas- 6 point scale.

4.Subject has at least 2 dark spots on face that are age spots/lentigines-marks other than melasma/chloasma.

5.In case of having used fairness products/skin anti-aging products in the near past subject willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.

6.Subjects willing to abstain from using any cosmetic/ medicinal/ ayurvedic/ natural products other than the one provided for testing on face during the study course.

7.Female subjects of reproductive age group willing to undergo UPT at time of screening visit.

8.Subject who shows good tolerance (no sensitivity symptoms) to the investigational products during the skin sensitivity test

Exclusion Criteria

1.Subjects who are pregnant or lactating or contemplating pregnancy during the study course

2.Subjects with a known history or present condition of allergic response/ sensitivity to sun, sunscreens/ cosmetics/ fragrances

3.Subject having skin condition like psoriasis, atopic dermatitis or other cutaneous manifestations which would interfere with the test readings

4.Subjects on medications like retinoid, steroids, antihistamines, oral contraceptives, or those for hormonal balance which could compromise the study results

5.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation

6.Subjects having participated in a similar investigation in the past 2 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dermatological safety and anti- aging efficacy of the investigational product (IP) over baselineTimepoint: Approximately 8 weeks

Secondary Outcome Measures

Name	Time	Method
The safety of the investigational product (IP).Timepoint: Approximately 8 weeks