Dermatitis, AtopicPhase 4NCT00671528
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
A Phase 4 study testing Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin) and Cream (betamethasone diproprionate) in people with Dermatitis, Atopic and Eczema, Atopic, run by Organon and Co.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous
- What is being tested?
- Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin) and Cream (betamethasone diproprionate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
Read more
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.
- Being tested
- Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin), Cream (betamethasone diproprionate)
- Keywords
- Impetiginous
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases, Eczematous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)Drug
Also called QUADRIDERME® cream, SCH 000411
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| QUADRIDERME® cream | Experimental | QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) Receives: Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) |
| Betamethasone and Gentamicin | Active comparator | Combination of betamethasone diproprionate cream and gentamicin sulfate cream Receives: Drug: Cream (betamethasone diproprionate and gentamicin) |
| Betamethasone | Active comparator | Betamethasone diproprionate cream Receives: Drug: Cream (betamethasone diproprionate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1 (prior to start of treatment), 8, 15, 21, and 28.
Secondary outcomes (1)
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.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: terminated early due to lack of recruitment \[only 3 of 207 subjects were enrolled\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671528
- Sponsor's protocol ID
- P05134
- Other IDs
- EudraCT No.: 2007-004980-23
- Status last verified
- Feb 2022
- First submitted
- 1 May 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00671528
- Acronym / sponsor ID
- P05134
- Keywords
- Impetiginous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated early due to lack of recruitment \[only 3 of 207 subjects were enrolled\]
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 16 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUADRIDERME® cream | Experimental | Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) |
| Betamethasone and Gentamicin | Active comparator | Drug: Cream (betamethasone diproprionate and gentamicin)Combination of betamethasone diproprionate cream and gentamicin sulfate cream |
| Betamethasone | Active comparator | Drug: Cream (betamethasone diproprionate)Betamethasone diproprionate cream |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)Also: QUADRIDERME® cream, SCH 000411Betamethasone 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. | Drug | QUADRIDERME® cream |
| 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. | Drug | Betamethasone and Gentamicin |
| 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. | Drug | Betamethasone |
Primary outcome
Percent Improvement of Individually Measured Signs of the Disease
Time frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28.
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
1 secondary outcome
Number of Days Required to Achieve Total Remission
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin) and Cream (betamethasone diproprionate) in people with Dermatitis, Atopic and Eczema, Atopic, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Improvement of Individually Measured Signs of the Disease (time frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.