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

Phase 2

Completed

• Conditions: Jellyfish Dermatitis; Jellyfish Venoms
• Interventions: Drug: Ipomea pes-caprae ointment

• Registration Number: NCT00944203
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Area	Ipomea pes-caprae ointment	Test Area = Standard Treatment plus Ipomea pes-caprae oinment

Primary Outcome Measures

Name	Time	Method
Healing time of the Jellyfish dermatitis lesion (days)	Follow up to 28 days

Trial Locations

Locations (1)

Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University; 🇹🇭 Bangkok, Thailand