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

Sunburn Clinical Trial

Official title:

Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Gel) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Mild to Moderate Sunburn Related Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01237925
• Other study ID #: ERE 185v2-10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 8, 2010
• Last updated: November 8, 2010

Study information

• Verified date: November 2010
• Source: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Contact: Sérgio Schalka, M.D.
• Phone: +551136811334
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Sunburn

Intervention

Drug:
• Dexchlorpheniramine 1% gel
Small amount applied over the lesion twice a day for 7 days
• Dexchlorpheniramine 1% cream
Small amount applied over the lesion twice a day for 7 days

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele Ltda	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Mantecorp Industria Quimica e Farmaceutica Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)	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.	7 days	No
Secondary	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	No