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

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ClinicalTrials.gov Identifier: NCT00944203
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Watcharapong Piyaphanee, Mahidol University

Brief Summary:
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 or disease Intervention/treatment Phase
Jellyfish Dermatitis Jellyfish Venoms Drug: Ipomea pes-caprae ointment Phase 2

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  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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



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


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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

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


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

Responsible Party: Watcharapong Piyaphanee, Doctor, Mahidol University
ClinicalTrials.gov Identifier: NCT00944203     History of Changes
Other Study ID Numbers: TMEC09-031
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Dermatitis
Skin Diseases