Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Holly Mangrove Shower Gel; Other: Placebo shower gel

• Registration Number: NCT02178215
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-30
• Study Start: 2014-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holly Mangrove Shower Gel	Holly Mangrove Shower Gel	•Wash forearm by Holly Mangrove Showver gel twice a day
Placebo shower gel	Placebo shower gel	•Wash forearm by prepared placebo shower gel twice a day

Primary Outcome Measures

Name	Time	Method
Improvement of skin barrier function	baseline, 2 week	•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

Name	Time	Method
Reduction of severity of pruritus	baseline, 2 week	Evaluation of pruritus by using visual analog scale

Trial Locations

Locations (1)

Siriraj Hospital Mahidol Univeristy; 🇹🇭 Bangkok, Thailand