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

Mantercorp

Status and phase

Unknown

Phase 3

Conditions

Sunburn

Treatments

Drug: Dexchlorpheniramine 1% lotion

Drug: Dexchlorpheniramine 1% cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT01085851

ERE 976-08

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

2 to 60 years old

Volunteers

No Healthy Volunteers

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