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

Primary Purpose

Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)

Cream (betamethasone diproprionate and gentamicin)

Cream (betamethasone diproprionate)

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Impetiginous

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

QUADRIDERME® cream

Betamethasone and Gentamicin

Betamethasone

Arm Description

QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)

Combination of betamethasone diproprionate cream and gentamicin sulfate cream

Betamethasone diproprionate cream

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00671528

First Posted

May 1, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00671528

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

terminated early due to lack of recruitment [only 3 of 207 subjects were enrolled]

Study Start Date

July 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous

Keywords

Impetiginous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QUADRIDERME® cream

Arm Type

Experimental

Arm Description

QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)

Arm Title

Betamethasone and Gentamicin

Arm Type

Active Comparator

Arm Description

Combination of betamethasone diproprionate cream and gentamicin sulfate cream

Arm Title

Betamethasone

Arm Type

Active Comparator

Arm Description

Betamethasone diproprionate cream

Intervention Type

Drug

Intervention Name(s)

Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)

Other Intervention Name(s)

QUADRIDERME® cream, SCH 000411

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cream (betamethasone diproprionate and gentamicin)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cream (betamethasone diproprionate)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent Improvement of Individually Measured Signs of the Disease

Description

Time Frame

Days 1 (prior to start of treatment), 8, 15, 21, and 28.

Secondary Outcome Measure Information:

Title

Number of Days Required to Achieve Total Remission

Description

The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.

Time Frame

Up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Learn more about this trial

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

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