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

Mahidol University

Status and phase: Completed; Phase 2

Conditions: Jellyfish Venoms; Jellyfish Dermatitis

Treatments: Drug: Ipomea pes-caprae ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT00944203

TMEC09-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Test Area

Experimental group

Description:

Test Area = Standard Treatment plus Ipomea pes-caprae oinment

Treatment:

Drug: Ipomea pes-caprae ointment

Control Area

No Intervention group

Description:

Control = Standard Treatment