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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexchlorpheniramine 1% gel | Experimental |
| |
| Dexchlorpheniramine 1% cream | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexchlorpheniramine 1% gel | Drug | Small amount applied over the lesion twice a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Measure | Description | 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). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sérgio Schalka, M.D. | Contact | +551136811334 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele Ltda | Osasco | São Paulo | 06023-000 | Brazil |
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| ID | Term |
|---|---|
| D013471 | Sunburn |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
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| ID | Term |
|---|---|
| C018904 | dexchlorpheniramine |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Dexchlorpheniramine 1% cream | Drug | Small amount applied over the lesion twice a day for 7 days |
|
| D014947 |
| Wounds and Injuries |