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

This study is currently recruiting participants.
Verified March 2016 by Watcharapong Piyaphanee, Mahidol University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944203
First Posted: July 23, 2009
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Watcharapong Piyaphanee, Mahidol University
  Purpose
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.

Condition Intervention Phase
Jellyfish Dermatitis Jellyfish Venoms Drug: Ipomea pes-caprae ointment Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis

Further study details as provided by Watcharapong Piyaphanee, Mahidol University:

Primary Outcome Measures:
  • Healing time of the Jellyfish dermatitis lesion (days) [ Time Frame: Follow up to 28 days ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944203


Contacts
Contact: Watcharapong Piyaphanee, MD +662-3549100 ext 1428 tewpe@mahidol.ac.th
Contact: Valai Busarathid, MD +662-3549100 ext 1428 tmvbs@mahidol.ac.th

Locations
Thailand
Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University Recruiting
Bangkok, Thailand, 10400
Principal Investigator: Watcharapong Piyaphanee, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Watcharapong Piyaphanee, MD Mahidol University
  More Information

Responsible Party: Watcharapong Piyaphanee, Doctor, Mahidol University
ClinicalTrials.gov Identifier: NCT00944203     History of Changes
Other Study ID Numbers: TMEC09-031
First Submitted: July 22, 2009
First Posted: July 23, 2009
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Watcharapong Piyaphanee, Mahidol University:
jellyfish
jellyfish venom
jellyfish dermatitis
jellyfish stings
Ipomea pes-caprae

Additional relevant MeSH terms:
Dermatitis
Skin Diseases