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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011621
Recruitment Status : Unknown
Verified November 2009 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2010
Estimated Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment. [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011621


Contacts
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Contact: Cláudia Domingues 55115188.5237 cdomingues@mantecorp.com

Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
Investigators
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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
More Information
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Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltd
ClinicalTrials.gov Identifier: NCT01011621    
Other Study ID Numbers: PRE/P/08-1
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009
Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Prednisolone acetate
Betamethasone valerate
Additional relevant MeSH terms:
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Dermatitis, Atopic
Psoriasis
Dermatitis
Skin Diseases
Dermatitis, Contact
Dermatitis, Seborrheic
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sebaceous Gland Diseases
Prednisolone
 Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Prednisolone hemisuccinate
Prednisolone phosphate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists