CClinicalTrials.gg
CompletedNCT07423325Updated Aug 6, 2026

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.

An interventional study of Marketed Product - CeraVe Moisturizer in Dry and Sensitive Skin, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

Each subject will serve as their own control, with right side of the face receiving the ceramide-containing moisturizer and the left side receiving water application as the control. This split-face approach reduces inter-subject variability and enables direct intra-individual comparison of the measurement methods across treated and control sites.

The study involves a single on-site visit for each subject.

  • Baseline (pre-application): Subjects will undergo acclimatization in a controlled environment, after which baseline assessments will be performed for skin parameters on both test and control sites.
  • Application phase: The ceramide-containing moisturizer and water control will be applied to the randomized sites under investigator supervision.
  • Post-application assessments: Instrumental evaluations will be done at T15 mins following product application.
02

Conditions studied

  • Dry and Sensitive Skin
03

In context

Lead sponsor

NovoBliss Research Pvt Ltd is the lead sponsor of 45 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

    5) 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.

    7) 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.

    8) Subjects are willing to give written informed consent and are willing to come for regular follow up.

    9) Subjects who commit not to use any other skincare products for the entire duration of the study.

    10) Subject who has not participated in a similar investigation in the past three months.

    11) Willing to use test product throughout the study period.

Exclusion criteria

Exclusion Criteria:

  • 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.

    5) 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.

    6) History of alcohol or drug addiction. 7) Subjects using other marketed products during the study period. 8) Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.

    9) Pregnant or breastfeeding or planning to become pregnant during the study period.

    10) 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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

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

    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

  • No intervention
    Arm 2 - Water Control Group

    Water will be applied to the specified, evaluated site.

Interventions

  • OtherMarketed Product - CeraVe Moisturizer

    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.

06

What researchers measure

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.

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

    Change in Skin Roughness 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.

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

    Change in Skin Scaliness 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

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

    Change in Sebum Level assessed by Sebumeter SM 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

07

Study locations

1 site
  • NovoBliss Research
    Ahmedabad, Gujarat 382481, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07423325
Lead sponsor
NovoBliss Research Pvt Ltd
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Jan 28, 2026
Primary completion
Jan 28, 2026
Completion
Jan 28, 2026
Last update
Aug 6, 2026

Study contacts

Nayan Patel
principal investigator · NovoBliss Research Private Limited

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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