Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

Study Overview
=================
Brief Summary
-----------------
Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are many cosmeceutical skin products in which their major action affects skin hydration and skin barrier function. In addition, there are some herbal medication remedies used for the treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up appointment showed significant improvement. Nevertheless, the knowledge of using this herbal medication for treating pruritic skin rash so far has been categorized as folk wisdom and not been confirmed by any clinical-trial study on its efficacy and mechanism of action. Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier function in atopic dermatitis.

Detailed Description
-----------------
The investigators team research with patients by separate patients into 2 groups and compare among each other. In the first group use placebo, the other group use Holly Mangrove Shower Gel. To compare outcomes, the investigators will measure transepidermal water loss, stratum corneum hydration, skin pH, sebum and wrinkles after using studied gel.

Official Title
-----------------
Effect of Holly Mangrove Shower Gel Containing Acanthus Ebracteatus Vahl. on Skin Barrier Function in Atopic Dermatitis Patients

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Placebo shower gel
* Other: Holly Mangrove Shower Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years old or above Diagnosed as atopic dermatitis (Hanafin and Rajka criteria) No active dermatitis within 2 weeks Exclusion Criteria: Pregnancy or lactation Any other skin diseases on forearms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo shower gel<br>•Wash forearm by prepared placebo shower gel twice a day | Other: Placebo shower gel<br>* Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks<br>|
| Active Comparator: Holly Mangrove Shower Gel<br>•Wash forearm by Holly Mangrove Showver gel twice a day | Other: Holly Mangrove Shower Gel<br>* Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of skin barrier function | •Measurement of bioengineering property of skin using Tewameter (transepidermal water loss), Corneometer (stratum corneum hydration), pH meter (skin pH), sebumeter (sebum), and visioscan (wrinkle) | baseline, 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of severity of pruritus | Evaluation of pruritus by using visual analog scale | baseline, 2 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis, skin barrier function, transepidermal water loss, skin pH, stratum corneum hydration, sebum, wrinkle