Health TrialsbyHealthPanel

Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction

ConditionsPsoriasisAtopic DermatitisXerosisContact Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMakati Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Novel barrier repair topical product

    Other intervention

    Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)

  • Petrolatum

    Other intervention

    Petrolatum application

Treatment groups

26 Participants
are divided into 3 treatment groups
Group A: Right Arm: Applying Test ProductExperimental treatment 1 intervention
Group B: Left Arm: Applying no topicalsNo intervention 0 interventions
Group C: Petrolatum: Right Arm: Applying PetrolatumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Transepidermal water loss

using a Tewameter

Time frame
28 days
2

Skin hydration

Using a Corneometer

Time frame
28 days
3

Skin sebum

Using a Sebumeter

Time frame
28 days
4

Skin erythema and pigmentation

Using a Mexameter

Time frame
28 days

Secondary outcomes

1

Change in dryness

Measured by Visual Analog Scale

Time frame
28 days
2

Change in itch

Measured by Visual Analog Scale

Time frame
28 days
3

Ease in application

Using Patient Satisfaction Questionnaire

Time frame
28 days
4

Skin softness and smoothness

Patient Satisfaction Questionnaire

Time frame
28 days

Other outcomes

Sponsors and contacts

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

Makati Medical Center

Lead sponsor

Source ClinicalTrials.gov
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