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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00944203
First received: July 22, 2009
Last updated: July 21, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Mahidol University:

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

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr.Watcharapong Piyaphanee, Faculty of Tropical Medicine, Mahidol University
ClinicalTrials.gov Identifier: NCT00944203     History of Changes
Other Study ID Numbers: TMEC09-031
Study First Received: July 22, 2009
Last Updated: July 21, 2011
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Dermatitis
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014