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”

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2012

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 0.5% prednisolone acetate cream
• Active Comparator: 0.1% betamethasone valerate cream

Primary 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
    Safety Issue?: Yes

Secondary Measures

• Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.
  • Time Frame: 14 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Overall Clinical Trial Officials and Contacts

Mário C Pires, MD Principal Investigator Hospital Padre Bento de Guarulhos  

Overall Contact: Cláudia Domingues 55115188.5237 cdomingues@mantecorp.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01011621

Study ID Number: PRE/P/08-1

ClinicalTrials.gov Identifier: NCT01011621

Health Authority: Brazil: Ethics Committee