Back to results

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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

bathing and moisturizer application

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Skin Center, Faculty of Medicine, Srinkharinwirot University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Water

mild cleanser

Arm Description

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.)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02028546

First Posted

December 19, 2013

Last Updated

January 5, 2014

Sponsor

Srinakharinwirot University

1. Study Identification

Unique Protocol Identification Number

NCT02028546

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Srinakharinwirot University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Water

Arm Type

Experimental

Arm Description

Arm Title

mild cleanser

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

bathing and moisturizer application

Intervention Description

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))

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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.

Other Pre-specified Outcome Measures:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arisa Kaewkes, MSc dermatology

Organizational Affiliation

Skin center, Faculty of Medicine, Srinakharinwirot University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skin Center, Faculty of Medicine, Srinkharinwirot University

City

Bangkok

ZIP/Postal Code

10110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs