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

NCT00671528 | Terminated Phase 4 Results

• 2 other identifiers: P05134EudraCT No.: 2007-004980-23
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Impetiginous

Outcome Measures

Primary Outcomes (1)

• 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: 1. Cure- Complete remission 2. \> 75% reduction: Marked improvement 3. 50-75% reduction: Moderate improvement 4. 25-50% reduction: Slight improvement 5. \<25% reduction: Ineffectiveness 6. Worsening of signs \& symptoms

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

Secondary Outcomes (1)

• Number of Days Required to Achieve Total Remission

  Up to 28 days

Study Arms (3)

QUADRIDERME® cream

EXPERIMENTAL

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

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

Betamethasone and Gentamicin

ACTIVE COMPARATOR

Combination of betamethasone diproprionate cream and gentamicin sulfate cream

Drug: Cream (betamethasone diproprionate and gentamicin)

Betamethasone

ACTIVE COMPARATOR

Betamethasone diproprionate cream

Drug: Cream (betamethasone diproprionate)

Interventions

Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) DRUG

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.

Also known as: QUADRIDERME® cream, SCH 000411

QUADRIDERME® cream

Cream (betamethasone diproprionate and gentamicin) DRUG

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.

Betamethasone and Gentamicin

Cream (betamethasone diproprionate) DRUG

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.

Betamethasone

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases, Eczematous

Interventions

Clotrimazole; Gentamicins

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Limitations and Caveats

This study was terminated early due to lack of recruitment (only 3 of 201 participants were enrolled). Statistical analyses were not performed.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 9, 2022
• Results First Posted: June 16, 2011

Record last verified: 2022-02