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

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

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.

Study Overview

• Status: Terminated
• Conditions: Skin Diseases, Eczematous; Dermatitis, Atopic; Eczema, Atopic
• Intervention / Treatment: Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate); Drug: Cream (betamethasone diproprionate and gentamicin); Drug: Cream (betamethasone diproprionate)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QUADRIDERME® cream; QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)	Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate); Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night 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.; Other Names: QUADRIDERME® cream, SCH 000411
Active Comparator: Betamethasone and Gentamicin; Combination of betamethasone diproprionate cream and gentamicin sulfate cream	Drug: Cream (betamethasone diproprionate and gentamicin); Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night 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.
Active Comparator: Betamethasone; Betamethasone diproprionate cream	Drug: Cream (betamethasone diproprionate); Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Improvement of Individually Measured Signs of the Disease	Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator. The following scale was used: Cure- Complete remission; > 75% reduction: Marked improvement; 50-75% reduction: Moderate improvement; 25-50% reduction: Slight improvement; <25% reduction: Ineffectiveness; Worsening of signs & symptoms	Days 1 (prior to start of treatment), 8, 15, 21, and 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Required to Achieve Total Remission	The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.	Up to 28 days

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Impetiginous
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Dermatitis; Eczema; Skin Diseases; Dermatitis, Atopic; Skin Diseases, Eczematous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Asthmatic Agents; Respiratory System Agents; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Gentamicins; Clotrimazole; Miconazole
• Other Study ID Numbers: P05134; EudraCT No.: 2007-004980-23