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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00944203
Other study ID # TMEC09-031
Secondary ID
Status Completed
Phase Phase 2
First received July 22, 2009
Last updated March 20, 2018
Start date July 2009
Est. completion date March 2017

Study information

Verified date March 2018
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Ipomea pes-caprae ointment
Ipomea pes-caprae ointment will be applied twice a day as an add-on therapy.

Locations

Country Name City State
Thailand Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing time of the Jellyfish dermatitis lesion (days) Follow up to 28 days