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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003073-27 | EudraCT Number |
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The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.
The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.
The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.
This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C. propionate-Wash out-Corticosteroid 1 | Active Comparator | Clobetasol propionate Shampoo:
Wash-out up to 8 weeks Corticosteroid 1:
|
|
| C. propionate-Wash out-Corticosteroid 2 | Active Comparator | Clobetasol propionate Shampoo:
Corticosteroid 2:
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|
| C. propionate-Wash out-Corticosteroid 3 | Active Comparator | Clobetasol propionate Shampoo:
Corticosteroid 3:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. propionate - Corticosteroid 1 | Drug | Twice daily application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population. | End of period II (up to 16 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Giannetti, Professor | Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena | Modena | 41100 | Italy |
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| Label | URL |
|---|---|
| Study product information | View source |
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219 participants recruited.
Patients were enrolled in 18 centres in Italy, Spain, United Kingdom and Germany between 19 February 2007 until 22 January 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | C. Propionate-Wash Out-Corticosteroid 1 | Clobetasol propionate Shampoo first, then Corticosteroid 1 |
| FG001 | Corticosteroid 1-Wash Out-C. Propionate | Corticosteroid 1 first then Clobetasol propionate Shampoo |
| FG002 | C. Propionate-Wash Out-Corticosteroid 2 | Clobetasol propionate Shampoo first, then Corticosteroid 2 |
| FG003 | Corticosteroid 2-Wash Out-C. Propionate | Corticosteroid 2 first, then Clobetasol propionate shampoo |
| FG004 | C. Propionate -Wash Out-Corticosteroid 3 | Clobetasol propionate shampoo first then Corticosteroid 3 |
| FG005 | Corticosteroid 3-Wash Out-C. Propionate | Corticosteroid 3 first, then Clobetasol propionate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | C. Propionate Compared to Corticosteroid 1 | C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily |
| BG001 | C. Propionate Compared to Corticosteroid 2 | C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily |
| 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 |
| 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 | Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population. | Intent to Treat population (ITT). | Posted | Jul 2011 | Number | Percentage of participants | End of period II (up to 16 weeks) |
|
During the study period (maximum of 16 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 | Corticosteroid 1 | All subjects having used Corticosteroid 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UNCLEAR ABDOMINAL PAIN - MECHANICAL SUBILEUS | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzaneh SIDOU Clinical Project Manager | Galderma | 00 33 4 93 95 70 70 | 70 51 | farzaneh.sidou@galderma.com |
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| Corticosteroid 1-Wash out-C. propionate | Active Comparator | Clobetasol propionate Shampoo:
Corticosteroid 1:
|
|
| Corticosteroid 2-Wash out-C. propionate | Active Comparator | Clobetasol propionate Shampoo:
Corticosteroid 2:
|
|
| Corticosteroid 3-Wash out-C. propionate | Active Comparator | Clobetasol propionate Shampoo:
Corticosteroid 3:
|
|
| C. propionate- Corticosteroid 2 | Drug | Twice daily application |
|
|
| C. propionate -Corticosteroid 3 | Drug | Twice daily application |
|
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| Corticosteroid 1- C. propionate | Drug | Twice daily application |
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| Corticosteroid 2 - C. propionate | Drug | Twice daily application |
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| Corticosteroid 3 - C. propionate | Drug | Twice daily application |
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|
| Adverse Event |
|
| Withdrawal by Subject |
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| Protocol Violation |
|
| Subje stopped study |
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| Pregnancy |
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| Patien stopped study at visit 4 by error |
|
| BG002 | C. Propionate Compared to Corticosteroid 3 | C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | C. Propionate Compared to Corticosteroid 2 | C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily |
| OG002 | C. Propionate Compared to Corticosteroid 3 | C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily |
|
|
|
| 0 |
| 72 |
| 5 |
| 72 |
| EG001 | Corticosteroid 2 | All subjects having used Corticosteroid 2 | 2 | 67 | 11 | 67 |
| EG002 | Corticosteroid 3 | All subjects having used Corticosteroid 3 | 1 | 65 | 20 | 65 |
| EG003 | Clobetasol Propionate Shampoo | All subjects having used Clobetasol propionate shampoo | 3 | 199 | 5 | 199 |
| HOSPITALISATION DUE TO NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| HOSPITALIZATION DUE TO MALAISE | General disorders | Non-systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | Non-systematic Assessment |
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| RESPIRATORY INFECTION | Infections and infestations | Non-systematic Assessment |
|
| ALLERGIC REACTION | Immune system disorders | Non-systematic Assessment |
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| CHOLECYSTOLITHIASIS | Hepatobiliary disorders | Non-systematic Assessment |
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| HORDEOLUM | Infections and infestations | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | Non-systematic Assessment |
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| FOLLICULITIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| SKIN BURNING SENSATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| RHINITIS | Infections and infestations | Non-systematic Assessment |
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| IMPETIGO | Infections and infestations | Non-systematic Assessment |
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| RASH PUSTULAR | Infections and infestations | Non-systematic Assessment |
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| SINUSITIS | Infections and infestations | Non-systematic Assessment |
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| EAR INFECTION | Infections and infestations | Non-systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| EXPISTAXIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| SKIN IRRITATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
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| HEPATIC ENZYME INCREASED | Investigations | Non-systematic Assessment |
|
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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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.