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

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01011621

Collaborator

(none)

170

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic Dermatitis, Contact Dermatitis, Seborrheic Psoriasis	Drug: 0.5% prednisolone acetate cream Drug: 0.1% betamethasone valerate cream	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.5% prednisolone acetate cream	Drug: 0.5% prednisolone acetate cream Small amount applied over the lesion twice a day for 14 days.
Active Comparator: 0.1% betamethasone valerate cream	Drug: 0.1% betamethasone valerate cream Small amount applied over the lesion twice a day for 14 days.

Arm

Intervention/Treatment

Experimental: 0.5% prednisolone acetate cream

Drug: 0.5% prednisolone acetate cream

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

Active Comparator: 0.1% betamethasone valerate cream

Drug: 0.1% betamethasone valerate cream

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

Outcome Measures

Primary Outcome Measures

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

Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment. [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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