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.

NCT07423325 | Not Yet Recruiting

• 1 other identifier: NB250045-NB-V
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry and Sensitive Skin

Outcome Measures

Primary Outcomes (7)

• 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

  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.

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

  Change in Skin Hydration - assessed by Corneometer® CM 825

  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.

• 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

  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.

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

  Change in Skin Smoothness assessed by VisioScan® VC 20 Plus

  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.

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

  Change in Skin Roughness assessed by VisioScan® VC 20 Plus

  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.

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

  Change in Skin Scaliness assessed by VisioScan® VC 20 Plus

  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

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

  Change in Sebum Level assessed by Sebumeter SM 825

  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

Study Arms (2)

Arm 1 - Test Product . Subjects will receive the test product.

EXPERIMENTAL

The test cream will be applied topically to the designated treatment area. A sufficient quantity of the cream will be gently massaged into the skin using light circular motions until complete absorption. Participants were instructed to apply the product to clean, dry skin and to avoid washing the treated area for a minimum period following application to allow adequate penetration. The application procedure was standardized across all subjects and was continued consistently throughout the study duration as per the protocol.

Other: Marketed Product - CeraVe Moisturizer

Arm 2 - Water Control Group

NO INTERVENTION

Water will be applied to the specified, evaluated site.

Interventions

Marketed Product - CeraVe Moisturizer OTHER

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.

Arm 1 - Test Product . Subjects will receive the test product.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.
• \) Subject are generally in good health. 6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
• \) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
• \) Subjects are willing to give written informed consent and are willing to come for regular follow up.
• \) Subjects who commit not to use any other skincare products for the entire duration of the study.
• \) Subject who has not participated in a similar investigation in the past three months.
• \) Willing to use test product throughout the study period.

You may not qualify if:

• \) 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.
• \) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
• \) Pregnant or breastfeeding or planning to become pregnant during the study period.
• \) History of chronic illness which may influence the cutaneous state. 11) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Officials

• Nayan Patel

  NovoBliss Research Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 20, 2026
• Study Start: February 27, 2026
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02