In this study LactoSporin® would be compared with comparator for its effectiveness andsafety,on age related changes in the skin of healthy female Volunteers
Recruiting
- Conditions
- age related changes in the skin of healthy female participants with Fitzpatrick skin types III to V
- Registration Number
- CTRI/2022/01/039292
- Lead Sponsor
- SamiSabinsa Group Limited
- Brief Summary
This study is to evaluate the anti-skin aging benefits in 10 weeks by
dermatological assessment, self-assessment, non-invasive instrument
assessment.
Post enrolment to the study, baseline assessments will be performed which
includes Dermatological visual assessment, instrument assessment
(Cutometer, TEWL, Corneometer, Antera) and VISIA images will be captured
Participants will be provided with either the test product or placebo cream as
per the randomization and has to apply twice daily, morning and night before
bed on face, throughout the study for 10 weeks.
The participants will visit the study center at week 5 and week 10 for
the follow up assessments (as in baseline)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 48
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 •Participants with mild to moderate fine lines and wrinkles in periorbital area (Crow’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 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 Screening, Baseline,Day35 & | Day70. 2.Significant improvement of skin elasticity as assessed by dermatological Screening, Baseline,Day35 & | Day70. assessment and Cutometer measurement. Screening, Baseline,Day35 & | Day70. 3.Significant improvement in skin hydration as assessed by dermatological Screening, Baseline,Day35 & | Day70. assessment and Corneometer measurement Screening, Baseline,Day35 & | Day70. 4. Significance improvement in overall changes in skin appearance in terms of Screening, Baseline,Day35 & | Day70. signs of aging by Dermatological assessment Screening, Baseline,Day35 & | Day70.
- Secondary Outcome Measures
Name Time Method To evaluate the product safety by dermatologist assessment Evaluation of safety through monitoring skin tolerance & AE (Baseline, Day35 & Day70).
Trial Locations
- Locations (1)
MS Clinical Research Private Limited
🇮🇳Bangalore, KARNATAKA, India
MS Clinical Research Private Limited🇮🇳Bangalore, KARNATAKA, IndiaDr Mukesh RamnanePrincipal investigator09844020353mukesh.ramnane@mscr.in