Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
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ClinicalTrials.gov Identifier: NCT00995397 |
Recruitment Status
: Unknown
Verified October 2009 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was: Not yet recruiting
First Posted
: October 15, 2009
Last Update Posted
: October 22, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insect Bites | Drug: Dexchlorpheniramine 1% lotion Drug: Dexchlorpheniramine 1% cream | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |

Arm | Intervention/treatment |
---|---|
Experimental: Dexchlorpheniramine 1% lotion |
Drug: Dexchlorpheniramine 1% lotion
Small amount applied over the lesion twice a day for 7 days.
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Active Comparator: Dexchlorpheniramine 1% cream |
Drug: Dexchlorpheniramine 1% cream
Small amount applied over the lesion twice a day for 7 days.
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- Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS) [ Time Frame: 7 days ]
- 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 ]

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Ages Eligible for Study: | 2 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995397
Contact: Sérgio Schalka, MD | +551136811334 |
Brazil | |
Medcin Instituto da Pele Ltda. | Not yet recruiting |
Osasco, São Paulo, Brazil, 06023-000 | |
Contact: Patricia C Pinto |
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 |
First Posted: | October 15, 2009 Key Record Dates |
Last Update Posted: | October 22, 2009 |
Last Verified: | October 2009 |
Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Insect bites Dexchlorpheniramine Lotion Cream |
Additional relevant MeSH terms:
Insect Bites and Stings Bites and Stings Poisoning Chemically-Induced Disorders Wounds and Injuries Dexchlorpheniramine Chlorpheniramine Histamine H1 Antagonists |
Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipruritics Dermatologic Agents Anti-Allergic Agents |