Study to test the safety and effectiveness of test product to provide various skin benefits in participants over 56 days of test product usage
Not yet recruiting
- Conditions
- Female subjects in general good health
- Registration Number
- CTRI/2025/06/089217
- Lead Sponsor
- Antonio Puig S.A
- Brief Summary
This is a study to evaluate the safety and efficacy of a test product to provide various skin benefits utilizing a full-face single arm study design. Duration of testing [length of time]: 56 days. The study will include a variety of dermatological assessments, instrumental assessments, and self assessments from subjects. Study objectives: improvements in signs of the aging face, overall skin tone, dark spot reduction, skin elasticity and testing of the safety and tolerability of the test product.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
- Female subjects in general good health.
- Female subjects in the age group 20 to 65 years.
- Female subjects with all skin types, with 50% of subjects having sensitive skin.
- Female subjects with visible skin concerns such as dark spots, wrinkles, and uneven skin tone.
- 5.10 female subjects with sensitive eyes who regularly wear contact lenses.
- 6.Female subjects who are regular users of makeup.
Exclusion Criteria
- Subjects with known skin conditions that may impact the assessment.
- Subjects with any other signs of significant local irritation or skin disease.
- Subjects undergoing treatment of any skin condition on their face.
- Subject having active skin diseases.
- Subjects who have undergone facial treatments in past 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of efficacy of test product in reducing signs of ageing. Baseline, Day 28, Day 56. Assessment of the test products effectiveness in improving overall skin tone. Baseline, Day 28, Day 56. Evaluation of efficacy of the test product for reduction in dark spots. Baseline, Day 28, Day 56. Reduction in signs of ageing using Antera assessment. Baseline, Day 28, Day 56. Reduction in dark spot intensity using Spectrophotometer. Baseline, Day 28, Day 56. Evaluation of improvement in skin elasticity using Cutometer. Baseline, Day 28, Day 56.
- Secondary Outcome Measures
Name Time Method 1. Evaluation of Safety and tolerability of the test product through dermatological and ophthalmological assessments. 2. Assessment of prevention of dark spots through subject self assessment.
Trial Locations
- Locations (1)
MS Clinical Research Pvt. Ltd
🇮🇳Bangalore, KARNATAKA, India
MS Clinical Research Pvt. Ltd🇮🇳Bangalore, KARNATAKA, IndiaDr Mukta SachdevPrincipal investigator918040917253mukta.sachdev@msclinical.com