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

Mantercorp

Status and phase: Unknown; Phase 3

Conditions: Psoriasis; Dermatitis, Atopic; Dermatitis, Seborrheic; Dermatitis, Contact

Treatments: Drug: 0.5% prednisolone acetate cream; Drug: 0.1% betamethasone valerate cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011621

PRE/P/08-1

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

0.5% prednisolone acetate cream

Experimental group

Treatment:

Drug: 0.5% prednisolone acetate cream

0.1% betamethasone valerate cream

Active Comparator group

Treatment:

Drug: 0.1% betamethasone valerate cream