Dry and Sensitive SkinNCT07423325
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.
A study testing Marketed Product - CeraVe Moisturizer in people with Dry and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry and Sensitive Skin
- What is being tested?
- Marketed Product - CeraVe Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2026to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Dry and Sensitive Skin
- Being tested
- Marketed Product - CeraVe Moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Product - CeraVe MoisturizerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Marketed Product - CeraVe Moisturizer |
| Arm 2 - Water Control Group | No intervention | Water will be applied to the specified, evaluated site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start28 Jan 2026
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry and Sensitive SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423325
- Sponsor's protocol ID
- NB250045-NB-V
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07423325
- Acronym / sponsor ID
- NB250045-NB-V
- Conditions
- Dry and Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Test Product . Subjects will receive the test product. | Experimental | Other: Marketed Product - CeraVe MoisturizerThe 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. |
| Arm 2 - Water Control Group | No intervention | –Water will be applied to the specified, evaluated site. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed Product - CeraVe MoisturizerThe 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. | Other | Arm 1 - Test Product . Subjects will receive the test product. |
Primary outcome
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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.
Change in Skin Glow and least reflection factor - assessed by Skin Glossymeter GL 200
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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.
Change in Skin Hydration - assessed by Corneometer® CM 825
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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.
Change in Trans epidermal water loss (TEWL) - assessed by Tewameter TM Hex
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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.
Change in Skin Smoothness assessed by VisioScan® VC 20 Plus
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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.
Change in Skin Roughness assessed by VisioScan® VC 20 Plus
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters.
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
Change in Skin Scaliness assessed by VisioScan® VC 20 Plus
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters
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
Change in Sebum Level assessed by Sebumeter SM 825
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed Product - CeraVe Moisturizer in people with Dry and Sensitive Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters. (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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.