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

Phase 3

• Conditions: Dermatitis, Atopic; Dermatitis, Contact; Dermatitis, Seborrheic; Psoriasis
• Interventions: Drug: 0.5% prednisolone acetate cream; Drug: 0.1% betamethasone valerate cream

• Registration Number: NCT01011621
• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Last Update Submitted: 2009-11-10
• Study First Posted: 2009-11-11
• Last Update Posted: 2009-11-11
• Study Start: 2010-02
• Primary Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5% prednisolone acetate cream	0.5% prednisolone acetate cream	-
0.1% betamethasone valerate cream	0.1% betamethasone valerate cream	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.	14 days