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

Primary Purpose

Jellyfish Dermatitis, Jellyfish Venoms

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Ipomea pes-caprae ointment

About this trial

This is an interventional treatment trial for Jellyfish Dermatitis focused on measuring jellyfish, jellyfish venom, jellyfish dermatitis, jellyfish stings, Ipomea pes-caprae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Area

Control Area

Arm Description

Test Area = Standard Treatment plus Ipomea pes-caprae oinment

Control = Standard Treatment

Outcomes

Primary Outcome Measures

Healing time of the Jellyfish dermatitis lesion (days)

Secondary Outcome Measures

Full Information

NCT ID

NCT00944203

First Posted

July 22, 2009

Last Updated

March 20, 2018

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00944203

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jellyfish Dermatitis, Jellyfish Venoms

Keywords

jellyfish, jellyfish venom, jellyfish dermatitis, jellyfish stings, Ipomea pes-caprae

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Area

Arm Type

Experimental

Arm Description

Test Area = Standard Treatment plus Ipomea pes-caprae oinment

Arm Title

Control Area

Arm Type

No Intervention

Arm Description

Control = Standard Treatment

Intervention Type

Drug

Intervention Name(s)

Ipomea pes-caprae ointment

Intervention Description

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

Primary Outcome Measure Information:

Title

Healing time of the Jellyfish dermatitis lesion (days)

Time Frame

Follow up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Watcharapong Piyaphanee, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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