MedPath

To check anti-ageing benefit of products

Phase 2
Registration Number
CTRI/2024/04/066264
Lead Sponsor
AVT Natural Products Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Female adult subjects in general good health as determined from general physical examination, dermatological assessment.

2.Subjects in the age group of 30 to 50 years (both ages inclusive).

3.Subjects having dull or uneven skin or any other pigmentation.

4.Subject presenting at least 2 well defined dark spots of PIH or Acne or Age spots on the face.

5.Subject identified for fine lines of score 4 and above and wrinkles of score 2 and above

6.Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.

7.Subject who agrees not to use any other product or treatment or home remedy or except the provided product on their face during the study period other than the test product.

8.Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.

9.Subjects who agree not to expose to excessive direct sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).

10.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.

11.Subjects willing to abide by and comply with the study protocol.

Exclusion Criteria

1.Subject with any other signs of significant local irritation or skin disease.

2.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.

3.Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.

4.Subjects undergoing any treatment of any skin condition on their face.

5.Subjects not willing to discontinue other topical facial products.

6.Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.

7.Subjects who are pregnant and lactating (Self- declared).

8.Subject who has participated in a similar clinical investigation in the past two weeks.

9.Subjects with skin allergy, history of atopic dermatitis or psoriasis

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Improvement in hydration in comparison to Baseline and at different timepoints. <br/ ><br>•Improvement in skin barrier function in comparison to Baseline and at different timepoints. <br/ ><br>•Improvement in skin firmness/elasticity in comparison to Baseline and at different timepoints. <br/ ><br>•Improvement in Wrinkles, Fine lines and Dark Spots in comparison to Baseline and at different timepoints.Timepoint: Day -7 (washout), Day 0, Day 28, Day 56
Secondary Outcome Measures
NameTimeMethod
To evaluate dermatological safety and tolerability of the test product for the entire study duration.Timepoint: Day -7 (washout), Day 0, Day 28, Day 56
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