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

NCT ID: NCT02028546

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Water

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.)

Group Type: EXPERIMENTAL

bathing and moisturizer application

Intervention Type: 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))

mild cleanser

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.

Group Type: EXPERIMENTAL

bathing and moisturizer application

Intervention Type: 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))

Interventions

bathing and moisturizer application

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))

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Srinakharinwirot University

OTHER

Sponsor Role: lead

Responsible Party

Arisa Kaewkes

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arisa Kaewkes, MSc dermatology

Role: PRINCIPAL_INVESTIGATOR

Skin center, Faculty of Medicine, Srinakharinwirot University

Locations

Skin Center, Faculty of Medicine, Srinkharinwirot University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

Srinakharinwirot fund

Identifier Type: -

Identifier Source: org_study_id