MedPath

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

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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