The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Procedure: bathing and moisturizer application

• Registration Number: NCT02028546
• Lead Sponsor: Srinakharinwirot University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-02
• Study Completion: 2013-04
• Study First Submitted: 2013-12-19
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-05
• Last Update Submitted: 2014-01-05
• Study First Posted: 2014-01-07
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
mild cleanser	bathing and moisturizer application	The patients in mild cleanser group were soaking an arm for 10 minutes with mild cleanser before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.) Non soap base cleanser contained Sodium Cocoyl Isethionate was used in this mild cleanser arm.
Water	bathing and moisturizer application	The patients in water group were soaking an arm for 10 minutes with tap water before application of moisturizer. (Excepted the 4th regimen included no bathing, waited for 10 minutes and followed by moisturizer application.)

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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.	The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.

Trial Locations

Locations (1)

Skin Center, Faculty of Medicine, Srinkharinwirot University; 🇹🇭 Bangkok, Thailand