Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)

Condition(s) targeted: Dermatitis, Atopic; Eczema, Atopic; Skin Diseases, Eczematous

Intervention: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) (Drug); Cream (betamethasone diproprionate and gentamicin) (Drug); Cream (betamethasone diproprionate) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema:

- Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole and gentamicin

sulfate)

- Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream

- Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1: 1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Official title: Double-blind Evaluation of the Safety and Efficacy of Quadriderme® (Betamethasone Diproprionate, Clotrimazole and Gentamicin) Compared With Betamethasone Diproprionate Combined With Gentamicin Sulfate and With Betamethasone Diproprionate in the Treatment of Impetiginous Eczema

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent improvement of individually measured signs of the disease (in a given target area) assessed objectively by the investigator according to predefined scales: 0 to 5 for Erythema, Vesiculation, Scaling, and Pruritis; 1 to 6 for Overall Assessment.

Secondary outcome:

The speed of action, measured as the number of days required to achieve total remission.

Safety profile (adverse events, clinical laboratory tests, physical examination, and vital signs)

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Minimum age: 12 years

- Good general health confirmed by clinical history and a physical and skin examination

(excluding area of skin with impetiginous eczema).

- Diagnosis of impetiginous eczema.

- Ability to understand the procedures of the protocol and follow the requirements

during the course of the study.

- Results of routine laboratory tests - hemogram with leukogram and platelet count,

creatinine, glucose, sed. rate, IgE level and transaminases; along with plasma cortisol and ACTH levels prior to the start of the treatment. These results must all be within normal limits or not clinically relevant in order to be included in the trial.

Exclusion Criteria:

- Pregnant patients or women of childbearing age who are not using birth control

methods considered reliable by the attending physician.

- Patients with a history of hypersensitivity to any of the components of the

medication being studied.

- Patients in whom the extent or severity of the lesions requires treatment of a

different type than what is planned for this trial.

- Patients who need any other type of topical or systemic medication during the trial

that might affect the course of the disease.

- Patients who have been treated with other topical medications during the 14-day

period prior to the start of the trial.

- Patients who have received systemic corticosteroids or any other immunosuppressant

medication during the 28-day period prior to the start of the study.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 2, Leiria 2410-197, Portugal; Recruiting

Investigational Site 6, Lisboa 1069-166, Portugal; Recruiting

Starting date: July 2009
Last updated: September 13, 2010