Insect BitesPhase 3NCT01233934
Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
A Phase 3 study testing Dexchlorpheniramine 1% Gel and Dexchlorpheniramine 1% Cream in people with Insect Bites, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
Trial summary
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Insect Bites
- What is being tested?
- Dexchlorpheniramine 1% Gel and Dexchlorpheniramine 1% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Jul 2011
- Phase
- Phase 3
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of papules resulting from insect bites within the last 72 hours;
- Presence of symmetric lesions to compare one side to the other;
- Compliance of the subject to the treatment protocol;
- Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old.
Who cannot join
- Pregnancy or risk of pregnancy;
- Lactation;
- Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study;
- History of atopy or allergic diseases;
- History of allergy of any component of the formulations;
- Other conditions considered by the investigator as reasonable for non-eligibility.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, 06023000
Sergio Schalka, MD
About this study
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.
- Conditions
- Insect Bites
- Being tested
- Dexchlorpheniramine 1% Gel, Dexchlorpheniramine 1% Cream
- Keywords
- Insect bites, Dexchlorpheniramine, Gel, Cream
- 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.
Dexchlorpheniramine 1% GelDrug
Small amount applied over the lesion twice a day for 7 days.
Dexchlorpheniramine 1% CreamDrug
Small amount applied over the lesion twice a day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Dexchlorpheniramine 1% Cream | Active comparator | Not described Receives: Drug: Dexchlorpheniramine 1% Cream |
| Dexchlorpheniramine 1% Gel | Experimental | Not described Receives: Drug: Dexchlorpheniramine 1% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
Measured: 7 days
Secondary outcomes (1)
Composite Clinical Evaluation of Erythema, Pruritus and Papule Formation, Performed by the Investigator Using a 4-point Scale for Each One of the Parameters (Absent, Mild, Moderate, Intense). This Evaluation Constitutes the Insect Bite Score.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insect BitesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233934
- Sponsor's protocol ID
- ERP 185v3-10
- Status last verified
- Nov 2010
- First submitted
- 2 Nov 2010
- Last updated
- 3 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
- ClinicalTrials.gov ID
- NCT01233934
- Acronym / sponsor ID
- ERP 185v3-10
- Conditions
- Insect Bites
- Keywords
- Insect bites, Dexchlorpheniramine, Gel, Cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 3 Nov 2010 (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.
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexchlorpheniramine 1% Cream | Active comparator | Drug: Dexchlorpheniramine 1% Cream |
| Dexchlorpheniramine 1% Gel | Experimental | Drug: Dexchlorpheniramine 1% Gel |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Presence of papules resulting from insect bites within the last 72 hours;
- Presence of symmetric lesions to compare one side to the other;
- Compliance of the subject to the treatment protocol;
- Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old.
Key exclusion criteria (6 listed)
- Pregnancy or risk of pregnancy;
- Lactation;
- Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study;
- History of atopy or allergic diseases;
- History of allergy of any component of the formulations;
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 |
|---|---|---|
| Dexchlorpheniramine 1% GelSmall amount applied over the lesion twice a day for 7 days. | Drug | Dexchlorpheniramine 1% Gel |
| Dexchlorpheniramine 1% CreamSmall amount applied over the lesion twice a day for 7 days. | Drug | Dexchlorpheniramine 1% Cream |
Primary outcome
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
Time frame: 7 days
1 secondary outcome
Composite Clinical Evaluation of Erythema, Pruritus and Papule Formation, Performed by the Investigator Using a 4-point Scale for Each One of the Parameters (Absent, Mild, Moderate, Intense). This Evaluation Constitutes the Insect Bite Score.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexchlorpheniramine 1% Gel and Dexchlorpheniramine 1% Cream in people with Insect Bites, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Nov 2010. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Schalka, MD (551136811334, medci004@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS) (time frame: 7 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 3 Nov 2010.