Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexchlorpheniramine 1% lotion | Experimental |
| |
| Dexchlorpheniramine 1% cream | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexchlorpheniramine 1% lotion | 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) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sérgio Schalka, MD | Contact | +551136811334 |
| Name | Affiliation | Role |
|---|---|---|
| Sérgio Schalka, MD | Medcin Instituto da Pele Ltda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele Ltda | São Paulo | São Paulo | Brazil |
Not provided
| ID | Term |
|---|---|
| D013471 | Sunburn |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
Not provided
Not provided
| ID | Term |
|---|---|
| C018904 | dexchlorpheniramine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexchlorpheniramine 1% cream | Drug | Small amount applied over the lesion twice a day for 7 days |
|
| D014947 |
| Wounds and Injuries |