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

NCT01011621 | Unknown Phase 3 DMC

• 1 other identifier: PRE/P/08-1
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Prednisolone acetate; Betamethasone valerate

Outcome Measures

Primary Outcomes (1)

• Evaluate efficacy and safety of 0.5% prednisolone cream in comparison to 0.1% betamethasone cream in the treatment of corticosensitive dermatosis.

  14 days

Secondary Outcomes (1)

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

  14 days

Study Arms (2)

0.5% prednisolone acetate cream

EXPERIMENTAL

Drug: 0.5% prednisolone acetate cream

0.1% betamethasone valerate cream

ACTIVE COMPARATOR

Drug: 0.1% betamethasone valerate cream

Interventions

0.5% prednisolone acetate cream DRUG

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

0.5% prednisolone acetate cream

0.1% betamethasone valerate cream DRUG

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

0.1% betamethasone valerate cream

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sebaceous Gland Diseases; Skin Diseases, Papulosquamous

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cláudia Domingues

CONTACT

55115188.5237; cdomingues@mantecorp.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Last Updated: November 11, 2009

Record last verified: 2009-11