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).
This study is an exploratory, single-center, randomized, evaluator-blinded, contralateral-controlled clinical investigation designed to evaluate the effects of a sponsor-provided daily moisturizer on skin barrier function, hydration, inflammatory biomarkers, and skin microbiome composition in adults with sensitive skin. A total of 24 participants will be recruited, with a minimum of 20 participants expected to complete the study and be included in evaluable analyses. Participants will undergo a 7-day washout period followed by a 28-day treatment phase. Each participant will serve as their own control. One volar forearm will receive the investigational moisturizer and the contralateral forearm will receive an occlusive comparator control, White Petrolatum, USP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Dose per Application: 6 full pumps per application to the assigned forearm.
Dose per Application: 6 full pumps per application to the assigned forearm.
Sequential Skin
New York, New York, United States
RECRUITINGTransepidermal Water Loss (TEWL)
Time frame: Baseline and Day 28
Skin Hydration
Measured by MoistureMeterSC
Time frame: Baseline and Day 28
Skin Surface pH
Time frame: Baseline and Day 28
Protein Biomarkers
Collected by CuDerm Adhesive Tape Stripping
Time frame: Baseline and Day 28
Skin Microbiome
Collected by swabs
Time frame: Baseline and Day 28
Sensitive Scale-10 Questionnaire
Time frame: Baseline and Day 28
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