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A study to evaluate skin moisturization.

A randomized, double-blinded, controlled study to evaluate the efficacy of test products in providing skin moisturization and barrier protection for up to 24 hours in healthy subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052081
Enrollment
35
Registered
2023-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tvaksh Moisguard DN: An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syri

Sponsors

Abbott India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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. 15. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
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. 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. 3. To evaluate the deep moisturization: TEWL with a single application of the test product in comparison to the untreated site. 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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@msclinical.com08041125934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026