Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis

Conditions
-----------------
Dermatitis, Atopic, Dermatitis, Contact, Dermatitis, Seborrheic, Psoriasis

Intervention / Treatment
-----------------
* Drug: 0.5% prednisolone acetate cream
* Drug: 0.1% betamethasone valerate cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with corticosensitive dermatosis (atopic dermatitis, contact dermatitis, seborrheic dermatitis, psoriasis) mild to moderate in intensity; Compliance of the subject to the treatment protocol; Agreement with the terms o the informed consent by the participants Subjects who did not use the following medicines before inclusion: topical corticosteroids or other therapies to dermatitis (30 days); oral corticosteroids (180 days); parenteral corticosteroids (180 days); immunomodulators/immunosuppressor (30 days); any drug under investigation (1 year); any therapy for the studied clinical conditions (180 days); keratolytic agents (30 days); emollient agents (30 days); tazarotene (30 days); vitamin D (topical or oral, 30 days); methotrexate (30 days); acitretin (2 years); UV light (30 days); PUVA therapy (30 days). Exclusion criteria: Pregnancy or risk of pregnancy Lactation History of allergy of any component of the formulations Other conditions considered by the investigator as reasonable for non-eligibility HIV positivity Drug abuse Subjects without previous response to topical corticosteroids Subjects with intense sun exposure within 15 days of the screening

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5% prednisolone acetate cream<br> | Drug: 0.5% prednisolone acetate cream<br>* Small amount applied over the lesion twice a day for 14 days.<br>|
| Active Comparator: 0.1% betamethasone valerate cream<br> | Drug: 0.1% betamethasone valerate cream<br>* Small amount applied over the lesion twice a day for 14 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prednisolone acetate, Betamethasone valerate