Trial | NCT01011621  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    prednisone betamethasone ...

  • Study Participants

    170
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.
Study Started
Feb 28
2010
Primary Completion
Feb 29
2012
Anticipated
Last Update
Nov 11
2009
Estimate

Drug 0.5% prednisolone acetate cream

Small amount applied over the lesion twice a day for 14 days.

Drug 0.1% betamethasone valerate cream

Small amount applied over the lesion twice a day for 14 days.

0.5% prednisolone acetate cream Experimental

0.1% betamethasone valerate cream Active Comparator

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
No Results Posted