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

NCT00995397 | Unknown Phase 3 DMC

• 1 other identifier: ERP 976-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Insect Bites

Keywords

Insect bites; Dexchlorpheniramine; Lotion; Cream

Outcome Measures

Primary Outcomes (1)

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

  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.

  7 days

Study Arms (2)

Dexchlorpheniramine 1% lotion

EXPERIMENTAL

Drug: Dexchlorpheniramine 1% lotion

Dexchlorpheniramine 1% cream

ACTIVE COMPARATOR

Drug: Dexchlorpheniramine 1% cream

Interventions

Dexchlorpheniramine 1% lotion DRUG

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

Dexchlorpheniramine 1% lotion

Dexchlorpheniramine 1% cream DRUG

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

Dexchlorpheniramine 1% cream

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

Study Sites (1)

Medcin Instituto da Pele Ltda.

Osasco, São Paulo, 06023-000, Brazil

Location

MeSH Terms

Conditions

Insect Bites and Stings

Interventions

dexchlorpheniramine

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Sérgio Schalka, MD

CONTACT

+551136811334

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Last Updated: October 22, 2009

Record last verified: 2009-10

Locations

BR (1)