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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01011621
First received: November 9, 2009
Last updated: November 10, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Dermatitis, Contact
Dermatitis, Seborrheic
Psoriasis
 Drug: 0.5% prednisolone acetate cream
Drug: 0.1% betamethasone valerate cream
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

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. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: February 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011621

Contacts
Contact: Cláudia Domingues 55115188.5237 cdomingues@mantecorp.com

Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltd
ClinicalTrials.gov Identifier: NCT01011621     History of Changes
Other Study ID Numbers: PRE/P/08-1
Study First Received: November 9, 2009
Last Updated: November 10, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Prednisolone acetate
Betamethasone valerate

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Dermatitis, Contact
Psoriasis
Dermatitis, Seborrheic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Papulosquamous
Sebaceous Gland Diseases
Betamethasone-17,21-dipropionate
 Methylprednisolone acetate
Prednisolone acetate
Betamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Betamethasone sodium phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 21, 2013