Overview

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

Status:
Terminated
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
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. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Clotrimazole
Gentamicins
Miconazole
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 adrenocorticotropic hormone (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 participants or women of childbearing age who are not using birth control
methods considered reliable by the attending physician.

- Participants with a history of hypersensitivity to any of the components of the
medication being studied.

- Participants in whom the extent or severity of the lesions requires treatment of a
different type than what is planned for this trial.

- Participants who need any other type of topical or systemic medication during the
trial that might affect the course of the disease.

- Participants who have been treated with other topical medications during the 14-day
period prior to the start of the trial.

- Participants who have received systemic corticosteroids or any other immunosuppressant
medication during the 28-day period prior to the start of the study.