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The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C propionate 4/week + Ketoconasole 2/week | Experimental | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) |
|
| C propionate 2/week + Ketoconasole 2/week | Experimental | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) |
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| C propionate 2/week | Experimental | Clobetasol propionate shampoo 0.05% (2/week) |
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| Ketoconazole 2/week | Active Comparator | Ketoconazole shampoo 2% (2/week) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) | Drug | Association: clobetasol propionate shampoo & ketoconazole shampoo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Severity Score (TSS): Percent Change From Baseline at Week 4 | Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9. | baseline and week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Ortonne, MD | Nice Hospital (France) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Center | Bruges | Belgium | ||||
| Galderma Investigational Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21707573 | Derived | Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x. |
| Label | URL |
|---|---|
| Sponsor general information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | C Propionate 4/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) |
| FG001 | C Propionate 2/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) | Drug | Association: clobetasol propionate shampoo & ketoconazole shampoo |
|
| clobetasol propionate shampoo (2/week) | Drug | Monotherapy with clobetasol propionate shampoo |
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| ketoconazole shampoo (2/week) | Drug | Monotherpay ketoconazole shampoo (2/week) |
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| Brussels |
| Belgium |
| Galderma Investigational Center | Geel | Belgium |
| Galderma Investigational Center | Ghent | Belgium |
| Galderma Investigational Center | Liège | Belgium |
| Galderma Investigational Center | Mons | Belgium |
| Galderma Investigational Center | Paris | France |
| Galderma Investigational Center | Berlin | Germany |
| Galderma Investigational Center | Bonn | Germany |
| Galderma Investigational Center | Hamburg | Germany |
| Galderma Investigational Center | Lübeck | Germany |
| Galderma Investigational Center | Mahlow | Germany |
| Galderma Investigational Center | Wuppertal | Germany |
| Galderma Investigational Center | Guadalajara | Mexico |
| Galderma Investigational Center | México | Mexico |
| Galderma Investigational Center | Naucalpan | Mexico |
| Galderma Investigational Center | Zapopan, Jalisco | Mexico |
| Galderma Investigational Center | Seoul | South Korea |
| FG002 | C Propionate 2/Week | Clobetasol propionate shampoo 0.05% (2/week) |
| FG003 | Ketakonazol 2/Week | Ketoconazole shampoo 2% (2/week) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | C Propionate 4/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) |
| BG001 | C Propionate 2/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) |
| BG002 | C Propionate 2/Week | Clobetasol propionate shampoo 0.05% (2/week) |
| BG003 | Ketakonazol 2/Week | Ketoconazole shampoo 2% (2/week) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Severity Score (TSS): Percent Change From Baseline at Week 4 | Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9. | Intent To Treat (ITT) with Last Observation Carried Forward (LOCF) | Posted | Jul 2011 | Median | Full Range | Percent change | baseline and week 4 |
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During the study - 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C Propionate 4/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | 1 | 82 | 15 | 82 | ||
| EG001 | C Propionate 2/Week + Ketoconazole 2/Week | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | 0 | 82 | 18 | 82 | ||
| EG002 | C Propionate 2/Week | Clobetasol propionate shampoo 0.05% (2/week) | 1 | 82 | 17 | 82 | ||
| EG003 | Ketakonazol 2/Week | Ketoconazole shampoo 2% (2/week) | 0 | 80 | 16 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA11.0 | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA11.0 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
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| Dymenorrhoea | Reproductive system and breast disorders | MedDRA11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA11.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA11.0 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA11.0 | Non-systematic Assessment |
|
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzi Sidou, Clinical Project Manager | Galderma | +33 4 93 95 70 51 | farzaneh.sidou@galderma.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Mexico |
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| Belgium |
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| Germany |
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| Korea, Republic of |
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| The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population. | Cochran-Mantel-Haenszel | Each test was two-sided, at the 0.050 significance level. | 0.039 | 95 | Superiority or Other (legacy) |