None listed
Conditions
Interventions
Intervention1: PteroWhite® Cream: Twice a day application on full face up to 8 weeks
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female adult subjects in general good health. 2 Subjects in the age group of 38-60 years both inclusive. 3 Subject with Fitzpatrick skin types III to V. 4 Subjects having visible fine lines and wrinkles in periorbital area like Crowâ??s feet-under eye & forehead. 5 Subjects having skin aging concerns. 6 Subjects not having hair style which covers almost the entire forehead. 7 Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face. 8 Subject who agrees not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test product. 9 Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period. 10 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). 11 Subjects who agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging. 12 Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up. 13 Subjects willing to abide by and comply with the study protocol. 14 Subjects who have not participated in a similar investigation in past four weeks. 15 Subjects who are willing not to participate in any other clinical study during participation in the current study.
Exclusion criteria
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 chronic illness or had major surgery in the last year. 4 Subjects undergoing any treatment of any skin condition on their face/forearm. 5 Subjects not willing to discontinue other topical facial products. 6 Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else. 7 Subject pregnant or nursing. 8 Subjects taking medication including food supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Assessment by Dermatologist 2 Measurement by VISIA CR 2.2 3 Spectrophotometer Measurement 4 Cutometer Measurement 5 Corneometer Measurement 6 Antera-3D TM MeasurementTimepoint: 1 Dermatologist Assessment(Baseline,Week2,Week4 & Week8) 2 VISIA CR 2.2(Baseline,Week4 & Week8) 3 Spectrophotometer (Baseline,Week2 & Week4) 4 Cutometer (Baseline,Week2 & Week8) 5 Corneometer (Baseline,Week2 & Week8) 6 Antera-3D TM (Baseline,Week2 & Week8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety AssessmentTimepoint: Safety Assessment(Baseline, Week2,Week4 and Week8) | — |
Countries
India
Contacts
Public ContactDr Renuka Jain
Sami Labs Private Limited
Outcome results
None listed