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

Primary Purpose

Sunburn

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexchlorpheniramine 1% gel
Dexchlorpheniramine 1% cream
Sponsored by
Mantecorp Industria Quimica e Farmaceutica Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sunburn focused on measuring Sunburn, Dexchlorpheniramine, Gel, Cream

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medcin Instituto da Pele Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexchlorpheniramine 1% gel

Dexchlorpheniramine 1% cream

Arm Description

Outcomes

Primary Outcome Measures

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.

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).

Full Information

First Posted
November 8, 2010
Last Updated
November 8, 2010
Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01237925
Brief Title
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunburn
Keywords
Sunburn, Dexchlorpheniramine, Gel, Cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexchlorpheniramine 1% gel
Arm Type
Experimental
Arm Title
Dexchlorpheniramine 1% cream
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% gel
Intervention Description
Small amount applied over the lesion twice a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% cream
Intervention Description
Small amount applied over the lesion twice a day for 7 days
Primary Outcome Measure Information:
Title
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sérgio Schalka, M.D.
Phone
+551136811334
Facility Information:
Facility Name
Medcin Instituto da Pele Ltda
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06023-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sérgio Schalka, M.D.
Phone
+551136811334
First Name & Middle Initial & Last Name & Degree
Patrícia C. Pinto

12. IPD Sharing Statement

Learn more about this trial

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

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