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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01237925
First received: November 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Sunburn
 Drug: Dexchlorpheniramine 1% gel
Drug: Dexchlorpheniramine 1% cream
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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:
  • 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). [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Arms Assigned Interventions
Experimental: Dexchlorpheniramine 1% gel Drug: Dexchlorpheniramine 1% gel
Small amount applied over the lesion twice a day for 7 days
Active Comparator: Dexchlorpheniramine 1% cream Drug: Dexchlorpheniramine 1% cream
Small amount applied over the lesion twice a day for 7 days

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237925

Contacts
Contact: Sérgio Schalka, M.D. +551136811334

Locations
Brazil
Medcin Instituto da Pele Ltda Not yet recruiting
Osasco, São Paulo, Brazil, 06023-000
Contact: Sérgio Schalka, M.D.     +551136811334        
Principal Investigator: Patrícia C. Pinto            
Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
  More Information

No publications provided

Responsible Party: Celso Pereira Sustovich, Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier: NCT01237925     History of Changes
Other Study ID Numbers: ERE 185v2-10
Study First Received: November 8, 2010
Last Updated: November 8, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Sunburn
Dexchlorpheniramine
Gel
Cream

Additional relevant MeSH terms:
Sunburn
Photosensitivity Disorders
Skin Diseases
Burns
Wounds and Injuries
Dexchlorpheniramine
Chlorpheniramine
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013