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

Phase 3

• Conditions: Sunburn
• Interventions: Drug: Dexchlorpheniramine 1% gel; Drug: Dexchlorpheniramine 1% cream

• Registration Number: NCT01237925
• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Last Update Submitted: 2010-11-08
• Study First Posted: 2010-11-10
• Last Update Posted: 2010-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexchlorpheniramine 1% gel	Dexchlorpheniramine 1% gel	-
Dexchlorpheniramine 1% cream	Dexchlorpheniramine 1% cream	-

Primary Outcome Measures

Name	Time	Method
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)	7 days	The evaluation of the pruritus will be made by a 10-point visual analog scale, answered by patients at each visit. The sum of weighted scores will be calculated for each sign / symptom in each patient.

Secondary Outcome Measures

Name	Time	Method
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).	7 days

Trial Locations

Locations (1)

Medcin Instituto da Pele Ltda; 🇧🇷 Osasco, São Paulo, Brazil