Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

NCT02178215 | Completed Phase 3 DMC

• 1 other identifier: Si479/2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; skin barrier function; transepidermal water loss; skin pH; stratum corneum hydration; sebum; wrinkle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of severity of pruritus

  baseline, 2 week

Study Arms (2)

Placebo shower gel

PLACEBO COMPARATOR

•Wash forearm by prepared placebo shower gel twice a day

Other: Placebo shower gel

Holly Mangrove Shower Gel

ACTIVE COMPARATOR

•Wash forearm by Holly Mangrove Showver gel twice a day

Other: Holly Mangrove Shower Gel

Interventions

Placebo shower gel OTHER

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

Placebo shower gel

Holly Mangrove Shower Gel OTHER

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

Holly Mangrove Shower Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old or above
• Diagnosed as atopic dermatitis (Hanafin and Rajka criteria)
• No active dermatitis within 2 weeks

You may not qualify if:

• Pregnancy or lactation
• Any other skin diseases on forearms

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital Mahidol Univeristy

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Papapit Tuchinda, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

TH (1)