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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Dexchlorpheniramine 1% lotion
  • Active Comparator: Dexchlorpheniramine 1% cream

Clinical Trial Outcome Measures

Primary Measures

  • Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
    • Time Frame: 7 days

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mantecorp Industria Quimica e Farmaceutica Ltd.
  • Provider of Information About this Clinical Study
    • Celso Pereira Sustovich, Medical Director, Mantecorp Industria Quimica e Farmaceutica Ltd.
  • Overall Official(s)
    • Sérgio Schalka, MD, Principal Investigator, Medcin Instituto da Pele Ltda
  • Overall Contact(s)
    • Sérgio Schalka, MD, +551136811334

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