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

Condition(s) targeted: Sunburn

Intervention: Dexchlorpheniramine 1% lotion (Drug); Dexchlorpheniramine 1% cream (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Mantecorp Industria Quimica e Farmaceutica Ltd.

Official(s) and/or principal investigator(s):
Sérgio Schalka, MD, Principal Investigator, Affiliation: Medcin Instituto da Pele Ltda

Overall contact:
Sérgio Schalka, MD, Phone: +551136811334

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.

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 Sunburn Related Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)

Secondary outcome: Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).

Minimum age: 2 Years. Maximum age: 60 Years. Gender(s): Both.

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

Sérgio Schalka, MD, Phone: +551136811334

Medcin Instituto da Pele Ltda, São Paulo, SP, Brazil; Not yet recruiting
Patrícia C Pinto

Last updated: March 11, 2010