None listed
Conditions
Interventions
Intervention1: LactoSporin�®: Approximately one (1) FTU for full face.
Twice a day for 10 weeks
In the morning before participants do their activity and night before bed.
Control Intervention1: Pla
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: ââ?¬Â¢Female adult participants in general good health as determined from a recent medical history general physical examination, dermatological assessment. ââ?¬Â¢Participants in the age group of 35-65years (both ages inclusive). ââ?¬Â¢Subject with Fitzpatrick skin types III to V ââ?¬Â¢Participants with mild to moderate fine lines and wrinkles in periorbital area (Crowââ?¬•s feet-under eye) & forehead (Refer annexure I for photo-numerical scale) ââ?¬Â¢Participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the f ace. ââ?¬Â¢Participants who agree not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test product. ââ?¬Â¢Participants who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period. ââ?¬Â¢Participants 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). ââ?¬Â¢Participants who agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging. ââ?¬Â¢Participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow up. ââ?¬Â¢Participants willing to abide by and comply with the study protocol. ââ?¬Â¢Participants who have not participated in a similar investigation in past four weeks. ââ?¬Â¢Participants who are willing not to participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: �Participant with any other signs of significant local irritation or skin disease. �Participant currently taking any medication, which the Investigator believes may influence the interpretation of the data. �Participant having chronic illness or had major surgery in the last year. �Participants undergoing any treatment of any skin condition on their face/forearm. �Participants not willing to discontinue other topical facial products. �Participant allergic or sensitive to bar cleansing products, creams/lotions, or anything else. �Pregnant or nursing participant. �Participants taking medication including food supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Significant improvement of facial fine line; wrinkles as assessed by Antera 2.Significant improvement of skin elasticity as assessed by dermatological assessment and Cutometer measurement. 3.Significant improvement in skin hydration as assessed by dermatological assessment and Corneometer measurement 4. Significance improvement in overall changes in skin appearance in terms of signs of aging by Dermatological assessmentTimepoint: Screening, Baseline,Day35 & Day70. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the product safety by dermatologist assessmentTimepoint: Evaluation of safety through monitoring skin tolerance & AE (Baseline, Day35 & Day70). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld, a division of Sami-Sabinsa Group
Outcome results
None listed