CTRI/2020/03/023845
Completed
Phase 1
A study to evaluate the efficacy of test product for anti-ageing benefits and reduction of spots in healthy female subjects - None
Impres Health Pvt Ltd0 sites37 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Impres Health Pvt Ltd
- Enrollment
- 37
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- •2\.Subjects in the age group of 30\-50 years (both ages inclusive).
- •3\.Subject with Fitzpatrick skin types III to V
- •4\.Each subject should have hyperpigmentary regions (may include mild melasma or at least one spot of 3mm size)
- •5\.Subjects having visible fine lines and wrinkles in periorbital area (Crowââ?¬•s feet\-under eye) \& forehead.
- •6\.Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •7\.Subject who agrees not to use any other product/treatment/home remedy/ 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 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.
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 who do not agree to remove all jewelry on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
- •5\.Subjects having hair style which covers almost the entire forehead
- •6\.Subjects undergoing any treatment of any skin condition on their face/forearm.
- •7\.Subjects not willing to discontinue other topical facial products.
- •8\.Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
- •9\.Pregnant women (as confirmed by UPT) and lactating women
- •10\.Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
Outcomes
Primary Outcomes
Not specified
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