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Validation of Skin Instrumentation to Detect Ceramide-Driven Lipid Replenishment - Assessing Skin Glow, Hydration, Trans Epidermal Water Loss, Skin Surface Assessment, Sebum and Least-Reflection Factor.

ConditionDry and Sensitive Skin
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovoBliss Research Pvt Ltd

About this trial

This is a single-center, open-label, split-face, site-randomized validation study, NB250045-NB-V designed to establish and confirm the reliability, reproducibility, and sensitivity of various skin measurement methods. Evaluator blinding will be implemented to minimize observer bias.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1) Age: 18 to 55 years old (both inclusive) at the time of consent. 2) Sex: Healthy male and non-pregnant/non-lactating females. 3) Subject having normal, dry and sensitive skin. 4) Females of childbearing potential must have a self-reported negative pregnancy test.

Disqualifiers

1) History of any dermatological condition of the skin diseases. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subject having allergic response to the ink. 4) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Marketed Product - CeraVe Moisturizer

    Other intervention

    The test cream was applied topically once daily to the designated treatment area. An adequate amount was gently massaged into clean, dry skin until fully absorbed. Participants were instructed not to wash the treated area for a specified period after application. The application procedure was standardized and followed consistently throughout the study duration.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Arm 1 - Test Product . Subjects will receive the test product.Experimental treatment 1 intervention
Group B: Arm 2 - Water Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.

Change in Skin Glow and least reflection factor - assessed by Skin Glossymeter GL 200

Time frame
Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control.
2

To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.

Change in Skin Hydration - assessed by Corneometer® CM 825

Time frame
Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control.
3

To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.

Change in Trans epidermal water loss (TEWL) - assessed by Tewameter TM Hex

Time frame
Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control.
4

To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.

Change in Skin Smoothness assessed by VisioScan® VC 20 Plus

Time frame
Change in the parameters at baseline (before application) and at post-application at T15 mins following application of the ceramide-containing moisturizer and water control.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovoBliss Research Pvt Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: