Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis

March 20, 2018 updated by: Watcharapong Piyaphanee, Mahidol University
This is an open label, prospective, test of superiority efficacy trial of Ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis. Each patient will receive standard medical treatment depend on the severity of the disease. The doctor will divide the dermatitis area of each patient into two parts. Ipomea pes-caprae ointment will be applied as an add-on therapy to the "test area", while the ointment will not be applied to the "control area". Patients will be asked to come for follow up 6 times in the 28-days study period. Primary objective is to compare the healing time of dermatitis in both areas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The "Test area" and "Control area" are allocated in each participant. We use the Internal Control fashion. The healing time of each area will be collected as an outcome measure.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of jellyfish dermatitis
  • total lesion area is more than 4 square centimeter

Exclusion Criteria:

  • expose to jellyfish more than 7 days
  • severe systemic reaction to jellyfish
  • allergy to Ipomea pes-caprae or the component of the ointments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Area
Test Area = Standard Treatment plus Ipomea pes-caprae oinment
Drug: Ipomea pes-caprae ointment
Ipomea pes-caprae ointment will be applied twice a day as an add-on therapy.
No Intervention: Control Area
Control = Standard Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing time of the Jellyfish dermatitis lesion (days)
Time Frame: Follow up to 28 days
Follow up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Watcharapong Piyaphanee, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 22, 2009

First Posted (Estimate)

July 23, 2009

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMEC09-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Jellyfish Dermatitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe