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

November 10, 2009 updated by: Mantecorp Industria Quimica e Farmaceutica Ltd.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

Investigators

  • Principal Investigator: Mário C Pires, MD, Hospital Padre Bento de Guarulhos
  • Principal Investigator: Roberta F. J. Criado, MD, Faculdade d Medicina do ABC
  • Principal Investigator: Adilson Costa, MD, KOLderma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRE/P/08-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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