A study to evaluate the test product in anti-ageing benefits.
- Registration Number
- CTRI/2020/03/023845
- Lead Sponsor
- Impres Health Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
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.
11.Subjects willing to abide by and comply with the study protocol.
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.
11.Subjects with skin allergy history or atopic dermatitis or psoriasis
12.Subjects who have participated in any other clinical trial in the last 3 months.
13.Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
14.Subjects that was treated with Botox/filler /bio stimulatory molecules injection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Significant improvement of facial fine line; wrinkles and hyperpigmentation as assessed by Antera in comparison to baseline <br/ ><br>2.Significant improvement of skin elasticity as assessed by dermatological assessment and Cutometer measurement in comparison to baseline. <br/ ><br>3.Significant improvement in skin hydration using Corneometer in comparison to baseline. <br/ ><br>4.Significance improvement in overall changes in skin appearance in terms of spot by Dermatological assessment in comparison to baseline.Timepoint: Approximately 3 months (90 days) for each subject
- Secondary Outcome Measures
Name Time Method To evaluate the product safety and tolerance by skin tolerance evaluation by dermatologist assessment.Timepoint: Approximately 3 months (90 days) for each subject