Evaluate the safety and efficacy of test product in improvement of skin .
- Registration Number
- CTRI/2023/02/050063
- Lead Sponsor
- ZeusHygia Life sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1.Healthy female subjects in the age group of 35-65 years (both age inclusive)
2. Female subjects with dark spots, pimple marks and facial pigmentation
3. Subjects with skin phototype IV to VI
4. Females subjects with a stable hormonal status and related endocrine diseases, as
self-declared by subjects.
5. Subjects with minimum grade 2 of crow’s feet wrinkles as per Skin aging atlas, volume
IV Indian skin type, by BAZIN & FLAMENT
6. Subjects willing to give a voluntary written informed consent and comply with
the requirement of the study.
1.Known hypersensitivity to any of the study products or constituents or cosmetics
2. Any significant skin pathology in the test area (face)
3. Currently taking any medication including food supplements, which the Investigator
believes may influence the interpretation of the data
4. Having chronic illness or had major surgery in the last year.
5. Subjects having any significant ophthalmic illness or have undergone eye surgery in the
past 6 months
6. Subjects who has got nose piercing/ facial piercing in past 6 months
7. Subjects with active/ inflamed pimple or any active lesion on the face
8. Undergoing any treatment of any skin condition on their face/body
9. Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery, or
anything else
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Changes in Clinical score of Crow’s feet wrinkles, forehead wrinkles & forehead fine <br/ ><br>lines done by Dermatologist using Skin aging atlas, volume IV Indian type, by BAZIN & <br/ ><br>FLAMENT. <br/ ><br>2.Responses from subjective evaluation questionnaire filled by subjects for efficacy , safety and product attributes like skin feels moisturized and soft to touch, <br/ ><br>smoothness and radiance, improvement in wrinkles. <br/ ><br>3.Instrument measurements- Visioscan /Visioline for the measurement of wrinkles, <br/ ><br>skin roughness, scaliness. <br/ ><br>4.Corneometer to evaluate the skin moisturization. <br/ ><br>5.Cutometer Measurements for elasticity and firmness. <br/ ><br>6.Measurement by VISIA CR to measure skin pigmentation, UV spots, sun damage, <br/ ><br>texture, skin color and tone and wrinkles. <br/ ><br>7.TEWL Measurement Using Tewameter to assess the skin hydration. <br/ ><br>8.Tyrosinase Biomarker Identification.Timepoint: Day 1, Day 15, Day 30 and Day 60.
- Secondary Outcome Measures
Name Time Method The number of reported Adverse Event will be assessed by investigator throughout <br/ ><br>the study.Timepoint: From Day 1 to Day 60