- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237925
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
November 8, 2010 updated by: Mantecorp Industria Quimica e Farmaceutica Ltd.
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
124
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sérgio Schalka, M.D.
- Phone Number: +551136811334
Study Locations
-
-
São Paulo
-
Osasco, São Paulo, Brazil, 06023-000
- Medcin Instituto da Pele Ltda
-
Contact:
- Sérgio Schalka, M.D.
- Phone Number: +551136811334
-
Principal Investigator:
- Patrícia C. Pinto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexchlorpheniramine 1% cream
|
Small amount applied over the lesion twice a day for 7 days
|
Experimental: Dexchlorpheniramine 1% gel
|
Small amount applied over the lesion twice a day for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
Time Frame: 7 days
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 8, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 10, 2010
Study Record Updates
Last Update Posted (Estimate)
November 10, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Wounds and Injuries
- Burns
- Photosensitivity Disorders
- Sunburn
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Chlorpheniramine
- Dexchlorpheniramine
Other Study ID Numbers
- ERE 185v2-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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