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

Insect Bites Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00995397
• Other study ID #: ERP 976-08
• Status: Unknown status
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: October 20, 2009

Study information

• Verified date: October 2009
• Source: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Contact: Sérgio Schalka, MD
• Phone: +551136811334
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insect Bites
• Insect Bites and Stings

Intervention

Drug:
• Dexchlorpheniramine 1% lotion
Small amount applied over the lesion twice a day for 7 days.
• Dexchlorpheniramine 1% cream
Small amount applied over the lesion twice a day for 7 days.

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele Ltda.	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Mantecorp Industria Quimica e Farmaceutica Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS)		7 days
Secondary	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.		7 days