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

NCT01011621 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2009-11-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mantecorp Industria Quimica e Farmaceutica Ltd.

    lead INDUSTRY

Principal Investigators

  • Mário C Pires, MD · Hospital Padre Bento de Guarulhos

  • Roberta F. J. Criado, MD · Faculdade d Medicina do ABC

  • Adilson Costa, MD · KOLderma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011621 on ClinicalTrials.gov