To study the safety, effectiveness of an anti-ageing serum in Healthy Human volunteers.

Not Applicable

Completed

• Registration Number: CTRI/2021/11/038145
• Lead Sponsor: ITC LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-18
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 47

Inclusion Criteria

1. Indian/Asian female subjects

2. Healthy subjects between 35 and 60 years of age.

3. Skin in healthy state on the studied anatomic site (free of eczema, wounds, cuts, bruises,

inflammatory scar).

4. Mild to moderate wrinkles in the crow's feet area and/or nasolabial area and/or forehead

wrinkle.

5. Subjects who have not undergone any facial or anti-ageing procedures (e.g., Botulinum

toxin, dermal filler injections, laser resurfacing) in the past 3 months.

6.Subject should be willing to abstain from spa treatments/facials during the study period.

7. Subjects willing to abide by the study protocol and restriction (refrain from using any product

other than provided investigational product (IP)).

Exclusion Criteria

1.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the

determination of Pregnancy) or planning to conceive in coming 4-5 months.

2. Subjects with a present condition of allergic response to any cosmetic product.

3. Subjects undergoing treatment for any skin care concern.

4. Subjects under chronic medication (e.g., aspirin-based products, anti-inflammatories,

antihistamines etc.) that might influence the outcome of the study.

5. Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids,

or any other anti-acne medication) or any topical facial medication with in past 4 weeks.

6. Having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which

requires pharmaceutical treatment.

7. Subjects with excessive facial hair or scars on test sites (face and volar forearm), which could

interfere with evaluation.

8. Subjects having cutaneous hypersensitivity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Instrumental evaluation of <br/ ><br>1.Fine lines, wrinkles , deep wrinkles, pores, smoothness of skin , skin texture, <br/ ><br>hyperpigmentation spots, skin color (L, ITA), by Antera. <br/ ><br>2. Skin firmness on area under the jawline on the neck and elasticity by CutoMeter. <br/ ><br>3. Skin firmness and elasticity on cheek by CutoMeter <br/ ><br>4. Skin hydration by MMSC. <br/ ><br>5. Moisture in the deeper layers of skin by MMD (S15-1.5 mm deep). <br/ ><br>6. Skin gloss by Skin Glossmerer <br/ ><br>7. TEWL using VapoMeter. <br/ ><br>8. Skin pH by skin- pH- Meter <br/ ><br>Clinical evaluation of <br/ ><br>1. Jin-Ho-Chung scale for wrinkles in crow�s feet area. <br/ ><br>2. Wrinkles on forehead and in the nasolabial area. <br/ ><br>3. Pore severity.Timepoint: Day 0(pre and post prodict application) <br/ ><br>Week 1, <br/ ><br>Week 2, <br/ ><br>Week 4, <br/ ><br>Week 6, <br/ ><br>Week 8, <br/ ><br>Week 10

Secondary Outcome Measures

Name	Time	Method
1.Clinical evaluation for tolerance <br/ ><br>2.Self-assessment questionnaire for efficacy and tolerance. <br/ ><br>3.Digital PhotographsTimepoint: Day 0(pre and post prodict application) <br/ ><br>Week 1, <br/ ><br>Week 2, <br/ ><br>Week 4, <br/ ><br>Week 6, <br/ ><br>Week 8, <br/ ><br>Week 10 <br/ ><br> <br/ ><br>Digital Photographs will be taken at baseline, Week 4 and Week 10.