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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01011621
• Other study ID #: PRE/P/08-1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 9, 2009
• Last updated: November 10, 2009
• Start date: February 2010

Study information

• Verified date: November 2009
• Source: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Contact: Cláudia Domingues
• Phone: 55115188.5237
• Email: cdomingues[@]mantecorp.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Dermatitis, Contact
• Dermatitis, Seborrheic
• Eczema
• Psoriasis

Intervention

Drug:
• 0.5% prednisolone acetate cream
Small amount applied over the lesion twice a day for 14 days.
• 0.1% betamethasone valerate cream
Small amount applied over the lesion twice a day for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mantecorp Industria Quimica e Farmaceutica Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.		14 days	Yes
Secondary	Evaluate physicians' and patients' perception of the efficacy and tolerability of treatment.		14 days	No