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

Primary Purpose

Dermatitis, Atopic, Dermatitis, Contact, Dermatitis, Seborrheic

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

0.5% prednisolone acetate cream

0.1% betamethasone valerate cream

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Prednisolone acetate, Betamethasone valerate

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.5% prednisolone acetate cream

0.1% betamethasone valerate cream

Arm Description

Outcomes

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.

Secondary Outcome Measures

Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.

Full Information

NCT ID

NCT01011621

First Posted

November 9, 2009

Last Updated

November 10, 2009

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01011621

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Prednisolone acetate, Betamethasone valerate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.5% prednisolone acetate cream

Arm Type

Experimental

Arm Title

0.1% betamethasone valerate cream

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

0.5% prednisolone acetate cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.1% betamethasone valerate cream

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cláudia Domingues

Phone

55115188.5237

cdomingues@mantecorp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mário C Pires, MD

Organizational Affiliation

Hospital Padre Bento de Guarulhos

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Roberta F. J. Criado, MD

Organizational Affiliation

Faculdade d Medicina do ABC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adilson Costa, MD

Organizational Affiliation

KOLderma

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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