A study to evaluate skin moisturization.
- Registration Number
- CTRI/2023/05/052885
- Lead Sponsor
- Sami-Sabinsa Group Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Healthy female subjects, as determined from a recent medical history.
2. Subjects in the age group of 18-45 years (both ages inclusive).
3. Subjects who present normal to dry skin on the forearm (corneometer value of
35 as maximum)
4. Healthy skin in the test sites.
5. Subjects willing to give voluntary written informed consent and agree to come
for regular follow-up.
6. Subjects willing to abide by and comply with the study protocol.
7. Subjects who are willing not to participate in any other clinical study during participation in the current study.
1. Excessive hair on the test site
2. A known history or present condition of an allergic response to any cosmetic
products.
3. Change personal nutrition habits as well as sports habits
4. Start or change their oral hormonal treatment or their oral contraception.
5. Subject having active skin diseases (e.g., active atopic dermatitis, pigmented
contact dermatitis or other cutaneous manifestations), which will interfere with
the assessment.
6. Subjects on oral medications (e.g. steroids, anti-oxidant) which will
compromise the study.
7. Subjects had cancer in the last 10 years
8. Subjects with wounds, sunburn, scars, tattoos or piercings at the skin test
site(s)
9. Subjects with application of ointments, creams etc. for antibacterial, anti allergic or immunosuppressive treatment of the skin at the test site(s)
10.Systemic treatment which may modify the cutaneous state on the day of
inclusion or in the previous 30 days, including retinoid therapy.
11. History of intense sun exposure and/ photo toxicity/allergy.
12.Female subjects who are pregnant, lactating or nursing.
13.Chronic illness which may influence the cutaneous state.
14.Subject participating in any other cosmetic or therapeutic trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate and compare skin moisturization using Corneometer – CM 825 with a single application of the test product in comparison to the baseline and untreated control. <br/ ><br>2. To evaluate the retention of skin moisturization for immediate, 4 hours, 8 hours, and 24 hours using Corneometer – CM 825 with a single application of the test product in comparison to the untreated site. <br/ ><br>3. To evaluate the deep moisturization: TEWL with a single application of the test product in comparison to the untreated site. <br/ ><br>4. To measure and compare TEWL at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product in comparison to the baseline and untreated control. Timepoint: Baseline, Immediate, 4 hours, 8 hours and 24 hours
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy based on the dermatological visual assessment at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product compared to the baseline and untreated control.Timepoint: Baseline, Immediate, 4 hours, 8 hours and 24 hours