Health TrialsbyHealthPanel

A Clinical Investigation of a Topical Moisturizer on Skin Barrier Function in Adults With Sensitive Skin

ConditionSensitive Skin
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGood Molecules, LLC

About this trial

The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about inflammation), and the skin microbiome (the microorganisms that naturally live on the skin) in adults with sensitive skin, when compared with a commonly used moisturizing ointment (White Petrolatum) a widely used occlusive ointment (an ointment that forms a protective layer over the skin to help reduce moisture loss).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 55 years, inclusive, of any sex.

Self-declared sensitive skin affecting the body, characterized by unpleasant sensations such as burning, stinging, itching, tingling, tightness, or irritation in response to products or environmental triggers.

Must present a TEWL value ≥15 g/m2/h on a volar forearm at the screening visit (T-7).

Approximately 40-60% of enrolled participants should have Fitzpatrick skin types I-III, and approximately 40-60% should have Fitzpatrick skin types IV-VI.

Disqualifiers

Pregnancy, breastfeeding, or planning pregnancy during the study.

Active dermatologic disease on the forearms, visible scars, or tattoos that interfere with measurement.

History of chronic inflammatory or autoimmune conditions (rheumatoid arthritis, lupus, psoriasis, IBD, ankylosing spondylitis, multiple sclerosis).

Active cancer or cancer treatment within the past 5 years, with the exception of localized non-melanoma skin cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • White petrolatum

    Other intervention

    Dose per Application: 6 full pumps per application to the assigned forearm.

  • Investigational moisturizer

    Other intervention

    Dose per Application: 6 full pumps per application to the assigned forearm.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Occlusive comparator controlPlacebo comparator 1 intervention
Group B: Investigational moisturizerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Transepidermal Water Loss (TEWL)

Time frame
Baseline and Day 28
2

Skin Hydration

Measured by MoistureMeterSC

Time frame
Baseline and Day 28
3

Skin Surface pH

Time frame
Baseline and Day 28
4

Protein Biomarkers

Collected by CuDerm Adhesive Tape Stripping

Time frame
Baseline and Day 28

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Good Molecules, LLC

Lead sponsor

Sequential

Collaborator

Source ClinicalTrials.gov
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