Insect Bites and StingsPhase 1NCT00435552
Ease-it Spray for the Treatment of Fire Ant Stings
A Phase 1 study testing Ease-It Spray in people with Insect Bites and Stings, run by C.R.Darnall Army Medical Center.
Trial summary
The application of Ease-it Spray will alleviate pain secondary to fire ant stings more quickly than placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insect Bites and Stings
- What is being tested?
- Ease-It Spray
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2007to not given
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Adult
Who may be able to join
- AD soldier in US Army
- Ages 18-60
- Volunteer
- Absence of serious medical condition
- Past allergic reactions
- Asthma
- History of (h/o) IFA sting
Who cannot join
- Inability to provide informed consent
- Known h/o hymenoptera allergic reaction
- Allergy to any component of the treatments
- Inability to follow-up
- Active medical condition
- Pregnancy
About this study
The application of Ease-it Spray will alleviate pain secondary to fire ant stings more quickly than placebo.
- Conditions
- Insect Bites and Stings
- Being tested
- Ease-It Spray
- Medical subject headings
- Insect Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ease-It SprayProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insect Bites and StingsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- C.R.Darnall Army Medical Center
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435552
- Sponsor's protocol ID
- C.2007.001
- Status last verified
- Jan 2007
- First submitted
- 14 Feb 2007
- Last updated
- 15 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ease-it Spray for the Treatment of Fire Ant Stings
- ClinicalTrials.gov ID
- NCT00435552
- Acronym / sponsor ID
- C.2007.001
- Conditions
- Insect Bites and Stings
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- C.R.Darnall Army Medical CenterUS federal agency
- Study start
- Feb 2007
- First posted
- 15 Feb 2007 (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.
The application of Ease-it Spray will alleviate pain secondary to fire ant stings more quickly than placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (7 listed)
- AD soldier in US Army
- Ages 18-60
- Volunteer
- Absence of serious medical condition
- Past allergic reactions
Key exclusion criteria (6 listed)
- Inability to provide informed consent
- Known h/o hymenoptera allergic reaction
- Allergy to any component of the treatments
- Inability to follow-up
- Active medical condition
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 |
|---|---|---|
| Ease-It Spray | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 15 Feb 2007.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ease-It Spray in people with Insect Bites and Stings, run by C.R.Darnall Army Medical Center.
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 7 inclusion and 6 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 15 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 15 Feb 2007.