Jellyfish DermatitisPhase 2NCT00944203
Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis
A Phase 2 study testing Ipomea pes-caprae ointment in people with Jellyfish Dermatitis and Jellyfish Venoms, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jellyfish Dermatitis, Jellyfish Venoms
- What is being tested?
- Ipomea pes-caprae ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of jellyfish dermatitis
- total lesion area is more than 4 square centimeter
Who cannot join
- expose to jellyfish more than 7 days
- severe systemic reaction to jellyfish
- allergy to Ipomea pes-caprae or the component of the ointments
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
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.
Read the 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.
- Conditions
- Jellyfish Dermatitis, Jellyfish Venoms
- Being tested
- Ipomea pes-caprae ointment
- Keywords
- jellyfish, jellyfish venom, jellyfish dermatitis, jellyfish stings, Ipomea pes-caprae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipomea pes-caprae ointmentDrug
Ipomea pes-caprae ointment will be applied twice a day as an add-on therapy.
| Study group | Role | What they receive |
|---|---|---|
| Test Area | Experimental | Test Area = Standard Treatment plus Ipomea pes-caprae oinment Receives: Drug: Ipomea pes-caprae ointment |
| Control Area | No intervention | Control = Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time of the Jellyfish dermatitis lesion (days)
Measured: Follow up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jellyfish DermatitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Watcharapong Piyaphanee, Mahidol University
- Investigators
- Watcharapong Piyaphanee, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944203
- Sponsor's protocol ID
- TMEC09-031
- Status last verified
- Mar 2018
- First submitted
- 22 Jul 2009
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ipomea Pes-caprae Ointment as an add-on Therapy in Patient With Jellyfish Dermatitis
- ClinicalTrials.gov ID
- NCT00944203
- Acronym / sponsor ID
- TMEC09-031
- Conditions
- Jellyfish Dermatitis, Jellyfish Venoms
- Keywords
- jellyfish, jellyfish venom, jellyfish dermatitis, jellyfish stings, Ipomea pes-caprae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Area | Experimental | Drug: Ipomea pes-caprae ointmentTest Area = Standard Treatment plus Ipomea pes-caprae oinment |
| Control Area | No intervention | –Control = Standard Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of jellyfish dermatitis
- total lesion area is more than 4 square centimeter
Key exclusion criteria (3 listed)
- expose to jellyfish more than 7 days
- severe systemic reaction to jellyfish
- allergy to Ipomea pes-caprae or the component of the ointments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipomea pes-caprae ointmentIpomea pes-caprae ointment will be applied twice a day as an add-on therapy. | Drug | Test Area |
Primary outcome
Healing time of the Jellyfish dermatitis lesion (days)
Time frame: Follow up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Watcharapong Piyaphanee, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipomea pes-caprae ointment in people with Jellyfish Dermatitis and Jellyfish Venoms, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time of the Jellyfish dermatitis lesion (days) (time frame: Follow up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.