Clinical trial NCT01011621: Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dermatitis, Atopic
Dermatitis, Contact
Dermatitis, Seborrheic
Psoriasis
Keywords: Prednisolone acetate
Betamethasone valerate
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 170
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.
timeFrame: 14 days
Secondary outcomes:
measure: Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Padre Bento de Guarulhos
name: Mário C Pires, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade d Medicina do ABC
name: Roberta F. J. Criado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KOLderma
name: Adilson Costa, MD
role: PRINCIPAL_INVESTIGATOR
References: