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

NCT ID: NCT01011621

Last Updated: 2009-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28

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.

Conditions

Dermatitis, Atopic; Dermatitis, Contact; Dermatitis, Seborrheic; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0.5% prednisolone acetate cream

Group Type: EXPERIMENTAL

0.5% prednisolone acetate cream

Intervention Type: DRUG

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

0.1% betamethasone valerate cream

Group Type: ACTIVE_COMPARATOR

0.1% betamethasone valerate cream

Intervention Type: DRUG

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

Interventions

0.5% prednisolone acetate cream

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

Intervention Type: DRUG

0.1% betamethasone valerate cream

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mantecorp Indústria Química e Farmacêutica Ltd

Principal Investigators

Mário C Pires, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Padre Bento de Guarulhos

Roberta F. J. Criado, MD

Role: PRINCIPAL_INVESTIGATOR

Faculdade d Medicina do ABC

Adilson Costa, MD

Role: PRINCIPAL_INVESTIGATOR

KOLderma

Central Contacts

Cláudia Domingues

Role: CONTACT

cdomingues@mantecorp.com

55115188.5237

Other Identifiers

PRE/P/08-1

Identifier Type: -

Identifier Source: org_study_id