Trial · NCT00671528
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
NCT00671528, Phase 4, Terminated, Organon and Co; results first posted 2011-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4). Trials, record NCT00671528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00671528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
- NCT number
- NCT00671528
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 3 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Dermatitis, Atopic, Eczema, Atopic, Skin Diseases, Eczematous
- Interventions
- Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate), Cream (betamethasone diproprionate and gentamicin), Cream (betamethasone diproprionate)
- First posted
- 2008-05-05
- Last updated
- 2022-02-09
- Other registries' IDs
- eudract:2007-004980-23
- Results first posted
- 2011-06-16
- 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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Improvement of Individually Measured Signs of the Disease | 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 |
| Secondary | Number of Days Required to Achieve Total Remission | Up to 28 days | The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Improvement of Individually Measured Signs of the Disease | Days 1 (prior to start of treatment), 8, 15, 21, and 28. | Due to lack of participant recruitment and therefore study termination, no analyses were performed. | ||
| SECONDARY | Number of Days Required to Achieve Total Remission | Up to 28 days | Days | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days Required to Achieve Total Remission | Quadriderme® Cream | 15 | Days | ||
| Number of Days Required to Achieve Total Remission | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 15 | Days | ||
| Number of Days Required to Achieve Total Remission | Betamethasone Diproprionate Cream | 8 | Days |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quadriderme® Cream | 1 | |
| Overall Study | STARTED | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 1 | |
| Overall Study | STARTED | Betamethasone Diproprionate Cream | 1 | |
| Overall Study | COMPLETED | Quadriderme® Cream | 1 | |
| Overall Study | COMPLETED | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 1 | |
| Overall Study | COMPLETED | Betamethasone Diproprionate Cream | 1 | |
| Overall Study | NOT COMPLETED | Quadriderme® Cream | 0 | |
| Overall Study | NOT COMPLETED | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 0 | |
| Overall Study | NOT COMPLETED | Betamethasone Diproprionate Cream | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quadriderme® Cream | ||
| Total, all-cause mortality | Betamethasone Diproprionate and Gentamicin Sulfate Cream | ||
| Total, all-cause mortality | Betamethasone Diproprionate Cream | ||
| Total, other adverse events | Quadriderme® Cream | 0 | 1 |
| Total, other adverse events | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 0 | 1 |
| Total, other adverse events | Betamethasone Diproprionate Cream | 0 | 1 |
| Total, serious adverse events | Quadriderme® Cream | 0 | 1 |
| Total, serious adverse events | Betamethasone Diproprionate and Gentamicin Sulfate Cream | 0 | 1 |
| Total, serious adverse events | Betamethasone Diproprionate Cream | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00671528
GET https://conductscience.org/api/trials/v1/NCT00671528/registered