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

January 5, 2014 updated by: Arisa Kaewkes, Srinakharinwirot University
The purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10110
        • Skin Center, Faculty of Medicine, Srinkharinwirot University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.)
Procedure: 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))
EXPERIMENTAL: 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.
Procedure: 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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: The skin hydration (capacitance value) and transepidermal water loss value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
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

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

Other Outcome Measures

Outcome Measure
Time Frame
Skin hydration(capacitance value) by using Corneometer and transepidermal water loss value by using Tewameter between water and mild cleanser
Time Frame: The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.
The skin hydration (capacitance value) and TEWL value were assessed at baseline and every 30 minutes for 120 minutes after each regimen.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Srinakharinwirot University

Investigators

  • Principal Investigator: Arisa Kaewkes, MSc dermatology, Skin center, Faculty of Medicine, Srinakharinwirot University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

January 5, 2014

First Posted (ESTIMATE)

January 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 5, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Srinakharinwirot fund

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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