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

NCT01237925 | Unknown Phase 3

• 1 other identifier: ERE 185v2-10
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Sunburn

Keywords

Sunburn; Dexchlorpheniramine; Gel; Cream

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Dexchlorpheniramine 1% gel

EXPERIMENTAL

Drug: Dexchlorpheniramine 1% gel

Dexchlorpheniramine 1% cream

ACTIVE COMPARATOR

Drug: Dexchlorpheniramine 1% cream

Interventions

Dexchlorpheniramine 1% gel DRUG

Small amount applied over the lesion twice a day for 7 days

Dexchlorpheniramine 1% gel

Dexchlorpheniramine 1% cream DRUG

Small amount applied over the lesion twice a day for 7 days

Dexchlorpheniramine 1% cream

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

Study Sites (1)

Medcin Instituto da Pele Ltda

Osasco, São Paulo, 06023-000, Brazil

Location

MeSH Terms

Conditions

Sunburn

Interventions

dexchlorpheniramine; Gels

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Sérgio Schalka, M.D.

CONTACT

+551136811334

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

BR (1)