Scalp Psoriasis
Conditions
Keywords
1 Galderma,, 2 Scalp Psoriasis, 3 Subject preference, 4 Clobetasol propionate, 5 Shampoo
Brief summary
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.
Detailed description
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.
Interventions
DRUGC. propionate - Corticosteroid 1
Twice daily application
DRUGC. propionate- Corticosteroid 2
Twice daily application
DRUGC. propionate -Corticosteroid 3
Twice daily application
DRUGCorticosteroid 1- C. propionate
Twice daily application
DRUGCorticosteroid 2 - C. propionate
Twice daily application
DRUGCorticosteroid 3 - C. propionate
Twice daily application
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, 18 years of age or older, * Subjects with moderate to severe scalp psoriasis, * Subjects who signed written informed consent prior to any study procedures.
Exclusion criteria
* Subjects who need systemic treatment for their body psoriasis, * Subjects who are at risk in terms of precautions, warnings and contra-indication, * Female subjects who are pregnant, nursing or planning a pregnancy during the study, * Subjects with a specific washout period for topical treatment(s) on the scalp, * Subjects with a specific washout period for systemic treatment(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | End of period II (up to 16 weeks) | 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. |
Countries
Italy
Participant flow
Recruitment details
Patients were enrolled in 18 centres in Italy, Spain, United Kingdom and Germany between 19 February 2007 until 22 January 2008
Pre-assignment details
219 participants recruited.
Participants by arm
| Arm | Count |
|---|---|
| C. Propionate Compared to Corticosteroid 1 C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily | 78 |
| C. Propionate Compared to Corticosteroid 2 C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily | 71 |
| C. Propionate Compared to Corticosteroid 3 C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily | 70 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 1 | 1 | 1 |
| Overall Study | Patien stopped study at visit 4 by error | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Subje stopped study | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 6 | 3 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | C. Propionate Compared to Corticosteroid 3 | Total | C. Propionate Compared to Corticosteroid 1 | C. Propionate Compared to Corticosteroid 2 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 13 Participants | 48 Participants | 20 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 170 Participants | 58 Participants | 55 Participants |
| Age, Continuous | 47.8 years STANDARD_DEVIATION 16.2 | 49.3 years STANDARD_DEVIATION 15.6 | 50.8 years STANDARD_DEVIATION 15.9 | 49.2 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment Germany | 34 participants | 105 participants | 36 participants | 35 participants |
| Region of Enrollment Italy | 16 participants | 48 participants | 16 participants | 16 participants |
| Region of Enrollment Spain | 9 participants | 23 participants | 9 participants | 5 participants |
| Region of Enrollment United Kingdom | 11 participants | 43 participants | 17 participants | 15 participants |
| Sex: Female, Male Female | 36 Participants | 113 Participants | 45 Participants | 32 Participants |
| Sex: Female, Male Male | 34 Participants | 106 Participants | 33 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 72 | 11 / 67 | 20 / 65 | 5 / 199 |
| serious Total, serious adverse events | 0 / 72 | 2 / 67 | 1 / 65 | 3 / 199 |
Outcome results
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.
Time frame: End of period II (up to 16 weeks)
Population: Intent to Treat population (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C. Propionate Compared to Corticosteroid 1 | Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | 28.5 Percentage of participants |
| C. Propionate Compared to Corticosteroid 2 | Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | 31.6 Percentage of participants |
| C. Propionate Compared to Corticosteroid 3 | Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator | 21.8 Percentage of participants |
Comparison: The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.p-value: 0.0003Wilcoxon (Mann-Whitney)
Comparison: The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.p-value: 0.007Wilcoxon (Mann-Whitney)
Comparison: The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.p-value: <0.0001Wilcoxon (Mann-Whitney)