Clinical trial NCT02028546: The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study
Official title: The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* male or female;
* Age range 18-45 years;
* Subjects have history and physical findings consistent with mild to moderate AD with SCORAD score ≤ 40;
* Stop using some drugs such as oral corticosteroid for at least 4 weeks, topical corticosteroid and calcineurin inhibitor for at least 2 weeks, food supplement such as evening primrose oil, wheat extract Flax seed oil sunflowerseed oil, borage oil and fish oil for at least 3 months;
* Subjects who have signed the written informed consent.

Exclusion Criteria:

* Subjects who have medical histories such as zinc or essential fatty acid deficiency, end stage renal disease, hypothyroidism, human immunodeficiency virus (HIV), malignancies, obstructive biliary disease, diabetes mellitus and in those who have had radiation or other medical histories that may interfere the outcome;
* Subjects who ingest drugs that could interfere with the study results such as diuretics, antiandrogens, lipid reducing agents, isotretinoin cimetidine;
* Subjects cannot enroll until the end of the project;
* Subjects who have allergy to any ingredient in the moisturizer or cleanser that will be used in the protocol;
* Pregnant woman or lactating woman.

Primary outcomes:
measure: Skin hydration (skin capacitance) by using Corneometer and the trans-epidermal water loss value by using Tewameter of various regimens of bathing and moisturizer application
timeFrame: The skin hydration (capacitance value) and transepidermal water loss value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
Secondary outcomes:
measure: skin hydration (capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between immediate and delayed (30 minutes) moisturizer application after bathing.
timeFrame: The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
Other outcomes:
measure: Skin hydration(capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between water and mild cleanser
timeFrame: The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
Locations:
city: Bangkok
country: Thailand
facility: Skin Center, Faculty of Medicine, Srinkharinwirot University
Study officials:
affiliation: Skin center, Faculty of Medicine, Srinakharinwirot University
name: Arisa Kaewkes, MSc dermatology
role: PRINCIPAL_INVESTIGATOR
References: