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Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms

Primary Purpose

Insect Bites

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexchlorpheniramine 1% lotion
Dexchlorpheniramine 1% cream
Sponsored by
Mantecorp Industria Quimica e Farmaceutica Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insect Bites focused on measuring Insect bites, Dexchlorpheniramine, Lotion, Cream

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medcin Instituto da Pele Ltda.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexchlorpheniramine 1% lotion

Dexchlorpheniramine 1% cream

Arm Description

Outcomes

Primary Outcome Measures

Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS)

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2009
Last Updated
October 20, 2009
Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00995397
Brief Title
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
Official Title
Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Insect Bite Related-symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insect Bites
Keywords
Insect bites, Dexchlorpheniramine, Lotion, Cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexchlorpheniramine 1% lotion
Arm Type
Experimental
Arm Title
Dexchlorpheniramine 1% cream
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% lotion
Intervention Description
Small amount applied over the lesion twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% cream
Intervention Description
Small amount applied over the lesion twice a day for 7 days.
Primary Outcome Measure Information:
Title
Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Schalka, MD
Phone
+551136811334
Facility Information:
Facility Name
Medcin Instituto da Pele Ltda.
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06023-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia C Pinto

12. IPD Sharing Statement

Learn more about this trial

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms

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