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Topical corticosteroids are largely used in dermatology. The major problem related to their use is that the same mechanisms underlying their therapeutic effects (antiinflammatory and antiproliferative) may lead to adverse events. Conditions sensitive to corticosteroids require formulations with mild to moderate potency while high-potency corticosteroids era required in less responsive conditions. The aim of the present study is to compare the safety and efficacy of prednisolone acetate 0.5% cream (mild-potency non-fluoridated corticosteroid) versus betamethasone valerate 0.1% cream (high-potency fluoridated corticosteroid) in the treatment of mild to moderate cortisosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis and psoriasis). The study hypothesis is that 0.5% prednisolone cream will be as effective as 0.1% betamethasone cream and will be an alternative option to treat corticosensitive dermatosis in body areas where the use of fluoridated corticosteroids is contraindicated, such as the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5% prednisolone acetate cream | Experimental |
| |
| 0.1% betamethasone valerate cream | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% prednisolone acetate cream | Drug | Small amount applied over the lesion twice a day for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment. | 14 days |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cláudia Domingues | Contact | 55115188.5237 | cdomingues@mantecorp.com |
| Name | Affiliation | Role |
|---|---|---|
| Mário C Pires, MD | Hospital Padre Bento de Guarulhos | Principal Investigator |
| Roberta F. J. Criado, MD | Faculdade d Medicina do ABC | Principal Investigator |
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| 0.1% betamethasone valerate cream | Drug | Small amount applied over the lesion twice a day for 14 days. |
|
| Adilson Costa, MD |
| KOLderma |
| Principal Investigator |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003877 | Dermatitis, Contact |
| D012628 | Dermatitis, Seborrheic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012625 | Sebaceous Gland Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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