SunburnPhase 3NCT01085851
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms
A Phase 3 study testing Dexchlorpheniramine 1% lotion and Dexchlorpheniramine 1% cream in people with Sunburn, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Sunburn
- What is being tested?
- Dexchlorpheniramine 1% lotion and Dexchlorpheniramine 1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sérgio Schalka, MD contact
Brazil1 site
Medcin Instituto da Pele Ltda
São Paulo, São Paulo
Patrícia C Pinto
About this study
Official title: 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
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.
- Conditions
- Sunburn
- Being tested
- Dexchlorpheniramine 1% lotion, Dexchlorpheniramine 1% cream
- Keywords
- Sunburn, Dexchlorpheniramine, Lotion, Cream
- Medical subject headings
- Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexchlorpheniramine 1% lotionDrug
Small amount applied over the lesion twice a day for 7 days
Dexchlorpheniramine 1% creamDrug
Small amount applied over the lesion twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dexchlorpheniramine 1% lotion | Experimental | Not described Receives: Drug: Dexchlorpheniramine 1% lotion |
| Dexchlorpheniramine 1% cream | Active comparator | Not described Receives: Drug: Dexchlorpheniramine 1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
Measured: 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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sérgio Schalka, MD, Principal investigator, Medcin Instituto da Pele Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085851
- Sponsor's protocol ID
- ERE 976-08
- Status last verified
- Oct 2009
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01085851
- Acronym / sponsor ID
- ERE 976-08
- Conditions
- Sunburn
- Keywords
- Sunburn, Dexchlorpheniramine, Lotion, Cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexchlorpheniramine 1% lotion | Experimental | Drug: Dexchlorpheniramine 1% lotion |
| Dexchlorpheniramine 1% cream | Active comparator | Drug: Dexchlorpheniramine 1% cream |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexchlorpheniramine 1% lotionSmall amount applied over the lesion twice a day for 7 days | Drug | Dexchlorpheniramine 1% lotion |
| Dexchlorpheniramine 1% creamSmall amount applied over the lesion twice a day for 7 days | Drug | Dexchlorpheniramine 1% cream |
Primary outcome
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
Time frame: 7 days
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sérgio Schalka, MD contact
Sérgio Schalka, MD principal investigator
Medcin Instituto da Pele Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexchlorpheniramine 1% lotion and Dexchlorpheniramine 1% cream in people with Sunburn, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Schalka, MD (+551136811334), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2010.