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A study to evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects.

A Single Center, Application Site Randomized, Blinded, Moisturization Study to Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058449
Enrollment
36
Registered
2023-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Intervention1: Alverise Cream: Approx. 50 mg, Neat, Single application on volar forearms Intervention2: Alvextra Cream: Approx. 50 mg, Neat, Single application on volar forearms Intervention3: Sotil

Sponsors

Encore Healthcare Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adult males and/or non-pregnant/non-lactating females with age 18 to 65 years (both inclusive at the time of consent). 2. Subjects having good general health as determined by the Investigator on the basis of medical history. 3. Female subjects of childbearing potential must have a negative urine pregnancy test performed at enrollment visit. 4. Subjects willing to follow all the acceptable forms of contraception as applicable. 5. Subjects with dry / normal skin. • Subjects with self-perceived normal skin. • Subjects with dry (readings between 30 – 40) as assessed by MoisturemeterSC.

Exclusion criteria

Exclusion criteria: 1. Subjects using Body milk /lotion / cream, cosmetics or any other body moisturizing product 3-5 days prior to study. 2. Subjects who are on systemic medication or any medications would compromise the study. 3. Chronic illness which may influence the cutaneous state. 4. Subjects having history of diabetes. 5. Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of test product in improving skin hydration/moisturization using MoistureMeterSCTimepoint: Day 01 [(Before application (i.e., baseline) and after application at 01 hour (plus 15 mins), 04 hours (plus 15 mins) and 6 hours (plus 15 mins)] and on Day 02 [24 hours (plus 15 mins) after application].

Secondary

MeasureTime frame
Product Perception QuestionnaireTimepoint: Day 02 [24 hours plus 15 mins) after application].;To evaluate the effectiveness of test product in improving the skin barrier function by measuring Transepidermal Water Loss (TEWL) using VapometerTimepoint: Day 01 [(Before application (i.e., baseline) and after application at 01 hour (plus 15 mins), 04 hours (plus 15 mins) and 6 hours (plus 15 mins)] and on Day 02 [24 hours (plus 15 mins) after application].;To evaluate the effectiveness of test product in improving the skin physical parameter by Dermatologist | Dermatologist Validated Scorer using 5-point scoring scale for skin dryness, skin roughness, skin redness/erythema, burning, itching and stinging and 8-point scoring scale for skin suppleness and softnessTimepoint: Day 01 [(Before application (i.e., baseline) and after application at 01 hour (plus 15 mins), 04 hours (plus 15 mins) and 6 hours (plus 15 mins)] and on Day 02 [24 hours (plus 15 mins) after application].

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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