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

NCT02028546 | Completed

• 1 other identifier: Srinakharinwirot fund
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• Skin hydration(capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between water and mild cleanser

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

Study Arms (2)

Water

EXPERIMENTAL

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.)

Procedure: bathing and moisturizer application

mild cleanser

EXPERIMENTAL

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.

Procedure: bathing and moisturizer application

Interventions

bathing and moisturizer application PROCEDURE

regimen 1: soaking an arm for 10 minutes, no moisturizer application regimen 2: soaking an arm for 10 minutes,immediate moisturizer application regimen 3: soaking an arm for 10 minutes, delayed moisturizer application for 30 min. regimen 4: wait for 10 minutes,no soaking, moisturizer application (moisturizer alone) (All regimens were completed in all patients with 2 visits (7 days interval))

Water; mild cleanser

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Srinakharinwirot University: lead

Study Sites (1)

Skin Center, Faculty of Medicine, Srinkharinwirot University

Bangkok, Bangkok, 10110, Thailand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Baths

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Officials

• Arisa Kaewkes, MSc dermatology

  Skin center, Faculty of Medicine, Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 7, 2014
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

TH (1)