Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Mantecorp Industria Quimica e Farmaceutica Ltd.
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT00995397
First received: October 14, 2009
Last updated: October 20, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insect Bites |
Drug: Dexchlorpheniramine 1% lotion Drug: Dexchlorpheniramine 1% cream |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Primary Outcome Measures:
- Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dexchlorpheniramine 1% lotion |
Drug: Dexchlorpheniramine 1% lotion
Small amount applied over the lesion twice a day for 7 days.
|
| Active Comparator: Dexchlorpheniramine 1% cream |
Drug: Dexchlorpheniramine 1% cream
Small amount applied over the lesion twice a day for 7 days.
|
Eligibility| Ages Eligible for Study: | 2 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995397
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995397
Contacts
| Contact: Sérgio Schalka, MD | +551136811334 |
Locations
| Brazil | |
| Medcin Instituto da Pele Ltda. | Not yet recruiting |
| Osasco, São Paulo, Brazil, 06023-000 | |
| Contact: Patricia C Pinto | |
Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
More Information
No publications provided
| Responsible Party: | Celso Pereira Sustovich, Medical Director, Mantecorp Industria Quimica e Farmaceutica Ltda. |
| ClinicalTrials.gov Identifier: | NCT00995397 History of Changes |
| Other Study ID Numbers: | ERP 976-08 |
| Study First Received: | October 14, 2009 |
| Last Updated: | October 20, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
|
Insect bites Dexchlorpheniramine Lotion Cream |
Additional relevant MeSH terms:
|
Chlorpheniramine Dexchlorpheniramine Anti-Allergic Agents Antipruritics Dermatologic Agents Histamine Agents Histamine Antagonists |
Histamine H1 Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015