NCT01011621

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

Status unknown Phase 3 Last updated 10 November 2009

What this trial tests

Phase 3 trial testing 0.5% prednisolone acetate cream in Dermatitis, Atopic in 170 participants. Status unknown.

Timeline

1 February 2010

Primary endpoint
1 February 2012

Quick facts

Lead sponsor	Mantecorp Industria Quimica e Farmaceutica Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	1 February 2010
Primary completion	1 February 2012

Drugs / interventions tested

• 0.5% prednisolone acetate cream — full drug profile →
• 0.1% betamethasone valerate cream — full drug profile →

Conditions studied

• Dermatitis, Atopic — all drugs for Dermatitis, Atopic →
• Dermatitis, Contact — all drugs for Dermatitis, Contact →
• Dermatitis, Seborrheic — all drugs for Dermatitis, Seborrheic →
• Psoriasis — all drugs for Psoriasis →

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd. — full company profile →

Who can join

Adults 12 to 60, any sex, with Dermatitis, Atopic or Dermatitis, Contact. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Topical anti-inflammatory agents for seborrhoeic dermatitis of the face or scalp.
   Kastarinen H, Oksanen T, Okokon EO, Kiviniemi VV, et al · · 2014 · cited 27× · PMID 24838779 · DOI 10.1002/14651858.cd009446.pub2