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

NCT ID: NCT01085851

Last Updated: 2010-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

Conditions

Sunburn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexchlorpheniramine 1% lotion

Group Type: EXPERIMENTAL

Dexchlorpheniramine 1% lotion

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

Dexchlorpheniramine 1% lotion

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

Inclusion Criteria

• Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
• Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
• 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 solar erythema of severe intensity
• 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

Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mantecorp Industria Quimica e Farmaceutica Ltd.

Principal Investigators

Sérgio Schalka, MD

Role: PRINCIPAL_INVESTIGATOR

Medcin Instituto da Pele Ltda

Locations

Medcin Instituto da Pele Ltda

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Sérgio Schalka, MD

Role: CONTACT

+551136811334

Facility Contacts

Patrícia C Pinto

Role: primary

Other Identifiers

ERE 976-08

Identifier Type: -

Identifier Source: org_study_id