Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178215
• Other study ID #: Si479/2013
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2014
• Last updated: March 15, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Placebo shower gel
Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks
• Holly Mangrove Shower Gel
Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks

Locations

Country	Name	City	State
Thailand	Siriraj Hospital Mahidol Univeristy	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reduction of severity of pruritus	Evaluation of pruritus by using visual analog scale	baseline, 2 week	No