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Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms

NCT ID: NCT01237925

Last Updated: 2010-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

Detailed Description

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Conditions

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Sunburn

Keywords

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Sunburn Dexchlorpheniramine Gel Cream

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexchlorpheniramine 1% gel

Group Type EXPERIMENTAL

Dexchlorpheniramine 1% gel

Intervention Type DRUG

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

Dexchlorpheniramine 1% cream

Group Type ACTIVE_COMPARATOR

Dexchlorpheniramine 1% cream

Intervention Type DRUG

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

Interventions

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Dexchlorpheniramine 1% gel

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

Intervention Type DRUG

Dexchlorpheniramine 1% cream

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
* 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
* Signs of severe sunburn (vesicles, bullae or ulceration)
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy to any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Mantecorp Industria Quimica e Farmaceutica Ltd.

Locations

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Medcin Instituto da Pele Ltda

Osasco, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Sérgio Schalka, M.D.

Role: CONTACT

Phone: +551136811334

Facility Contacts

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Sérgio Schalka, M.D.

Role: primary

Other Identifiers

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ERE 185v2-10

Identifier Type: -

Identifier Source: org_study_id