Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

NCT ID: NCT02178215

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo shower gel

•Wash forearm by prepared placebo shower gel twice a day

Group Type PLACEBO_COMPARATOR

Placebo shower gel

Intervention Type OTHER

Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks

Holly Mangrove Shower Gel

•Wash forearm by Holly Mangrove Showver gel twice a day

Group Type ACTIVE_COMPARATOR

Holly Mangrove Shower Gel

Intervention Type OTHER

Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks

Interventions

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Placebo shower gel

Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks

Intervention Type OTHER

Holly Mangrove Shower Gel

Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Papapit Tuchinda, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital Mahidol Univeristy

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si479/2013

Identifier Type: -

Identifier Source: org_study_id

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