PsoriasisNCT07183423
Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
A study testing Novel barrier repair topical product and Petrolatum in people with Psoriasis and Atopic Dermatitis, run by Makati Medical Center at 1 site in Philippines.
Trial summary
The goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Atopic Dermatitis, Xerosis
- What is being tested?
- Novel barrier repair topical product and Petrolatum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePhilippines
- Study dates
- 31 Aug 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild skin barrier dysfunction, including:
- Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators.
- Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%.
- Contact dermatitis
- Seasonal xerosis or clinically evident skin dryness
- Symmetrical or bilateral test areas available (volar forearm)
- Willing and able to provide informed consent and adhere to study procedures
Who cannot join
- Failure to meet any of the above inclusion criteria
- Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment
- Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks
- Open wounds or evidence of secondary infection at test sites
- Pregnant or breastfeeding women
- Multiple nevi, tattoos, dense body hair in the test areas
Show all 9Show fewer
- Debilitated or immunocompromised subjects
- Known or suspected hypersensitivity to the interventional product (or its ingredients) or petrolatum
- Refusal or failure to comply with the schedule of visits at the test site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site, 1 recruiting
- Recruiting
VMV Skin Research Center & Clinics
Makati City, National Capital Region, 1229
Danielle Besa, 639665394196, dbesa@vmvgroup.com
About this study
Official title: A Pilot Double-Blind Randomized Controlled Trial on the Efficacy and Safety of a Novel Skin Barrier Product Versus Petrolatum in Individuals With Skin Barrier Dysfunction
The goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. The main questions it aims to answer are:
Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction.
Read more
Participants will:
Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product
Read the detailed description
The goal of this randomized controlled trial is to determine the efficacy of a new barrier product (containing ceramide, virgin coconut oil, cholesterol) versus petrolatum in adults with skin barrier dysfunction (including mild to moderate psoriasis, atopic dermatitis, contact dermatitis, seasonal xerosis or clinically evident skin dryness).
The main questions it aims to answer are:
Primary Objective: In a pilot study, to compare the preliminary effectiveness of the test product (containing ceramides, cholesterol, coconut oil and monolaurin) versus petrolatum in improving skin barrier function, as measured by transepidermal water loss (using a Tewameter), skin hydration (using a Corneometer), skin lipids (using a Sebumeter) as well as skin erythema and pigmentation (using a Mexameter) over a four-week period.
Secondary Objectives:
To assess improvement in subjective symptoms (dryness, pruritus). To assess patient-reported outcomes, including comfort, ease of application, and overall satisfaction.
To monitor and compare any adverse events or skin reactions associated with both treatments.
Researchers will compare versus petrolatum to see if effects are comparable. Participants will upon enrollment to the study, be asked to accomplish the Personal Information Sheet and Patient Satisfaction Questionnaire. They will be taught how to mark the Visual Analogue Scale according to the degree of dryness and itch felt. They will accomplish this at Baseline, weeks 1, 2 and 4.
Non-invasive measurements will be done of: skin hydration (using Tewameter and Corneometer), skin sebum (using Sebumeter) and skin redness/pigmentation (using Mexameter) at baseline, weeks 1, 2, and 4. Pictures will also be taken of the test area at each visit.
All participants will be given a 1 or 3-week supply of either the test medication or the placebo in identical jars, color, and smell to maintain blinding. Refills will be given at each follow-up. Written instructions on how to use them will also be provided. The product will be applied twice daily on the right forearm for 28 days. The amount applied will be ⅛ teaspoon per application, with a plastic measuring spoon given for their use. They will be instructed not to apply the product to any other location. They will also be advised on the possible adverse effects and will be instructed to contact the investigator in case an adverse reaction happens. They will then be instructed to follow up after 1, 2, and 4 weeks.
- Conditions
- Psoriasis, Atopic Dermatitis, Xerosis, Contact Dermatitis
- Being tested
- Novel barrier repair topical product, Petrolatum
- Keywords
- Ceramides, Emollients, Skin care, Epidermis/Injuries, Coconut oil
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Dermatitis, Contact, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel barrier repair topical productOther
Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)
PetrolatumOther
Petrolatum application
| Study group | Role | What they receive |
|---|---|---|
| Right Arm: Applying Test Product | Experimental | Not described Receives: Other: Novel barrier repair topical product |
| Left Arm: Applying no topicals | No intervention | Not described |
| Petrolatum: Right Arm: Applying Petrolatum | Active comparator | Not described Receives: Other: Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss
using a Tewameter
Measured: 28 days
Skin hydration
Using a Corneometer
Measured: 28 days
Skin sebum
Using a Sebumeter
Measured: 28 days
Skin erythema and pigmentation
Using a Mexameter
Measured: 28 days
Secondary outcomes (5)
Change in dryness
Measured by Visual Analog Scale
Measured: 28 days
Change in itch
Measured by Visual Analog Scale
Measured: 28 days
Ease in application
Using Patient Satisfaction Questionnaire
Measured: 28 days
Skin softness and smoothness
Patient Satisfaction Questionnaire
Measured: 28 days
Satisfaction with product
Using Patient Satisfaction Questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start31 Aug 2025
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makati Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vermen Verallo-Rowell, Makati Medical Center
- Investigators
- Vermen M Verallo Rowell, MD, Principal investigator, VMV Skin Research Center & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183423
- Sponsor's protocol ID
- MMCIRB2025-06-91
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in skin barrier defects and tropical barrier products. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Double-Blind Randomized Controlled Trial on the Efficacy and Safety of a Novel Skin Barrier Product Versus Petrolatum in Individuals With Skin Barrier Dysfunction
- ClinicalTrials.gov ID
- NCT07183423
- Acronym / sponsor ID
- MMCIRB2025-06-91
- Conditions
- Psoriasis, Atopic Dermatitis, Xerosis, Contact Dermatitis
- Keywords
- Ceramides, Emollients, Skin care, Epidermis/Injuries, Coconut oil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Makati Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2025 (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.
The goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. The main questions it aims to answer are:
Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction.
Participants will:
Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product
Detailed description
The goal of this randomized controlled trial is to determine the efficacy of a new barrier product (containing ceramide, virgin coconut oil, cholesterol) versus petrolatum in adults with skin barrier dysfunction (including mild to moderate psoriasis, atopic dermatitis, contact dermatitis, seasonal xerosis or clinically evident skin dryness).
The main questions it aims to answer are:
Primary Objective: In a pilot study, to compare the preliminary effectiveness of the test product (containing ceramides, cholesterol, coconut oil and monolaurin) versus petrolatum in improving skin barrier function, as measured by transepidermal water loss (using a Tewameter), skin hydration (using a Corneometer), skin lipids (using a Sebumeter) as well as skin erythema and pigmentation (using a Mexameter) over a four-week period.
Secondary Objectives:
To assess improvement in subjective symptoms (dryness, pruritus). To assess patient-reported outcomes, including comfort, ease of application, and overall satisfaction.
To monitor and compare any adverse events or skin reactions associated with both treatments.
Researchers will compare versus petrolatum to see if effects are comparable. Participants will upon enrollment to the study, be asked to accomplish the Personal Information Sheet and Patient Satisfaction Questionnaire. They will be taught how to mark the Visual Analogue Scale according to the degree of dryness and itch felt. They will accomplish this at Baseline, weeks 1, 2 and 4.
Non-invasive measurements will be done of: skin hydration (using Tewameter and Corneometer), skin sebum (using Sebumeter) and skin redness/pigmentation (using Mexameter) at baseline, weeks 1, 2, and 4. Pictures will also be taken of the test area at each visit.
All participants will be given a 1 or 3-week supply of either the test medication or the placebo in identical jars, color, and smell to maintain blinding. Refills will be given at each follow-up. Written instructions on how to use them will also be provided. The product will be applied twice daily on the right forearm for 28 days. The amount applied will be ⅛ teaspoon per application, with a plastic measuring spoon given for their use. They will be instructed not to apply the product to any other location. They will also be advised on the possible adverse effects and will be instructed to contact the investigator in case an adverse reaction happens. They will then be instructed to follow up after 1, 2, and 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right Arm: Applying Test Product | Experimental | Other: Novel barrier repair topical product |
| Left Arm: Applying no topicals | No intervention | – |
| Petrolatum: Right Arm: Applying Petrolatum | Active comparator | Other: Petrolatum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of mild skin barrier dysfunction, including:
- Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators.
- Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%.
- Contact dermatitis
- Seasonal xerosis or clinically evident skin dryness
Key exclusion criteria (9 listed)
- Failure to meet any of the above inclusion criteria
- Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment
- Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks
- Open wounds or evidence of secondary infection at test sites
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Novel barrier repair topical productNovel barrier product (containing ceramide, virgin coconut oil, cholesterol) | Other | Right Arm: Applying Test Product |
| PetrolatumPetrolatum application | Other | Petrolatum: Right Arm: Applying Petrolatum |
Primary outcome
Transepidermal water loss
Time frame: 28 days
using a Tewameter
Skin hydration
Time frame: 28 days
Using a Corneometer
Skin sebum
Time frame: 28 days
Using a Sebumeter
Skin erythema and pigmentation
Time frame: 28 days
Using a Mexameter
5 secondary outcomes
Change in dryness
Time frame: 28 days
Change in itch
Time frame: 28 days
Ease in application
Time frame: 28 days
Skin softness and smoothness
Time frame: 28 days
Satisfaction with product
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in skin barrier defects and tropical barrier products. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Vermen M Verallo Rowell, MD principal investigator
VMV Skin Research Center & Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel barrier repair topical product and Petrolatum in people with Psoriasis and Atopic Dermatitis, run by Makati Medical Center at 1 site in Philippines.
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 9 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 Philippines. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina C Verallo Rowell, MD, MBA (639171478318, ccvrowell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss (time frame: 28 days). The study lists 4 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 19 Sep 2025.