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Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites

NCT ID: NCT01233934

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insect Bites

Keywords

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Insect bites Dexchlorpheniramine Gel Cream

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexchlorpheniramine 1% Cream

Group Type ACTIVE_COMPARATOR

Dexchlorpheniramine 1% Cream

Intervention Type DRUG

Small amount applied over the lesion twice a day for 7 days.

Dexchlorpheniramine 1% Gel

Group Type EXPERIMENTAL

Dexchlorpheniramine 1% Gel

Intervention Type DRUG

Small amount applied over the lesion twice a day for 7 days.

Interventions

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Dexchlorpheniramine 1% Gel

Small amount applied over the lesion twice a day for 7 days.

Intervention Type DRUG

Dexchlorpheniramine 1% Cream

Small amount applied over the lesion twice a day for 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Medical Director

Locations

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Medcin Instituto da Pele Ltda.

Osasco, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Sergio Schalka, MD

Role: CONTACT

Phone: 551136811334

Email: [email protected]

Other Identifiers

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ERP 185v3-10

Identifier Type: -

Identifier Source: org_study_id