Back to resultsEffect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Placebo shower gel
Holly Mangrove Shower Gel
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, skin barrier function, transepidermal water loss, skin pH, stratum corneum hydration, sebum, wrinkle
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
Sites / Locations
- Siriraj Hospital Mahidol Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo shower gel
Holly Mangrove Shower Gel
Arm Description
•Wash forearm by prepared placebo shower gel twice a day
•Wash forearm by Holly Mangrove Showver gel twice a day
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Reduction of severity of pruritus
Evaluation of pruritus by using visual analog scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02178215
Brief Title
Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients
Official Title
Effect of Holly Mangrove Shower Gel Containing Acanthus Ebracteatus Vahl. on Skin Barrier Function in Atopic Dermatitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, skin barrier function, transepidermal water loss, skin pH, stratum corneum hydration, sebum, wrinkle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo shower gel
Arm Type
Placebo Comparator
Arm Description
•Wash forearm by prepared placebo shower gel twice a day
Arm Title
Holly Mangrove Shower Gel
Arm Type
Active Comparator
Arm Description
•Wash forearm by Holly Mangrove Showver gel twice a day
Intervention Type
Other
Intervention Name(s)
Placebo shower gel
Intervention Description
Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks
Intervention Type
Other
Intervention Name(s)
Holly Mangrove Shower Gel
Intervention Description
Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks
Primary Outcome Measure Information:
Title
Improvement of skin barrier function
Description
•Measurement of bioengineering property of skin using Tewameter (transepidermal water loss), Corneometer (stratum corneum hydration), pH meter (skin pH), sebumeter (sebum), and visioscan (wrinkle)
Time Frame
baseline, 2 week
Secondary Outcome Measure Information:
Title
Reduction of severity of pruritus
Description
Evaluation of pruritus by using visual analog scale
Time Frame
baseline, 2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Papapit Tuchinda, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital Mahidol Univeristy
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients
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