In this study LactoSporin�® would be compared with comparator for its effectiveness andsafety,on age related changes in the skin of healthy female Volunteers

Not Applicable

• Registration Number: CTRI/2022/01/039292
• Lead Sponsor: SamiSabinsa Group Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

�Female adult participants in general good health as determined from a recent medical history general physical examination, dermatological assessment.

�Participants in the age group of 35-65years (both ages inclusive).

�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)

�Participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the f ace.

�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.

�Participants who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.

�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).

�Participants who agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging.

�Participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.

�Participants willing to abide by and comply with the study protocol.

�Participants who have not participated in a similar investigation in past four weeks.

�Participants who are willing not to participate in any other clinical study during participation in the current study.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Significant improvement of facial fine line; wrinkles as assessed by Antera <br/ ><br>2.Significant improvement of skin elasticity as assessed by dermatological <br/ ><br>assessment and Cutometer measurement. <br/ ><br>3.Significant improvement in skin hydration as assessed by dermatological <br/ ><br>assessment and Corneometer measurement <br/ ><br>4. Significance improvement in overall changes in skin appearance in terms of <br/ ><br>signs of aging by Dermatological assessmentTimepoint: Screening, Baseline,Day35 & <br/ ><br>Day70.

Secondary Outcome Measures

Name	Time	Method
To evaluate the product safety by dermatologist assessmentTimepoint: <br/ ><br>Evaluation of safety through monitoring skin tolerance & AE (Baseline, Day35 & Day70).