Scalp Seborrheic Dermatitis
Conditions
Brief summary
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
Detailed description
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.
Interventions
DRUGclobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
DRUGclobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
DRUGclobetasol propionate shampoo (2/week)
Monotherapy with clobetasol propionate shampoo
DRUGketoconazole shampoo (2/week)
Monotherpay ketoconazole shampoo (2/week)
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with moderate to severe scalp Seborrheic Dermatitis
Exclusion criteria
* Subjects suffering from psoriasis, * Subjects with a known allergy to one of the components of the test products, * Female subjects who are pregnant, nursing or planning a pregnancy during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Severity Score (TSS): Percent Change From Baseline at Week 4 | baseline and 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. |
Countries
Belgium, France, Germany, Mexico, South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| C Propionate 4/Week + Ketoconazole 2/Week Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | 82 |
| C Propionate 2/Week + Ketoconazole 2/Week Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | 82 |
| C Propionate 2/Week Clobetasol propionate shampoo 0.05% (2/week) | 82 |
| Ketakonazol 2/Week Ketoconazole shampoo 2% (2/week) | 80 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 |
| Overall Study | Familly constraint | 0 | 1 | 0 | 0 |
| Overall Study | Included after end of inclusions | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 | 3 |
| Overall Study | Never used study drugs | 1 | 0 | 0 | 0 |
| Overall Study | Pregnancy | 1 | 1 | 0 | 0 |
| Overall Study | Subject mistake | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
| Age, Categorical >=65 years | 15 Participants | 12 Participants | 8 Participants | 13 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 69 Participants | 71 Participants | 66 Participants | 271 Participants |
| Age, Continuous | 46.9 years STANDARD_DEVIATION 16 | 43.8 years STANDARD_DEVIATION 17.2 | 44.9 years STANDARD_DEVIATION 15.3 | 44.7 years STANDARD_DEVIATION 15.5 | 45.1 years STANDARD_DEVIATION 16 |
| Region of Enrollment Belgium | 9 participants | 7 participants | 9 participants | 8 participants | 33 participants |
| Region of Enrollment France | 12 participants | 11 participants | 12 participants | 12 participants | 47 participants |
| Region of Enrollment Germany | 35 participants | 37 participants | 34 participants | 34 participants | 140 participants |
| Region of Enrollment Korea, Republic of | 9 participants | 9 participants | 9 participants | 9 participants | 36 participants |
| Region of Enrollment Mexico | 17 participants | 18 participants | 18 participants | 17 participants | 70 participants |
| Sex: Female, Male Female | 36 Participants | 39 Participants | 38 Participants | 36 Participants | 149 Participants |
| Sex: Female, Male Male | 46 Participants | 43 Participants | 44 Participants | 44 Participants | 177 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 | 15 / 82 | 18 / 82 | 17 / 82 | 16 / 80 |
| serious Total, serious adverse events | 1 / 82 | 0 / 82 | 1 / 82 | 0 / 80 |
Outcome results
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.
Time frame: baseline and week 4
Population: Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C Propionate 4/Week + Ketoconazole 2/Week | Total Severity Score (TSS): Percent Change From Baseline at Week 4 | -71.4 Percent change |
| C Propionate 2/Week + Ketoconazole 2/Week | Total Severity Score (TSS): Percent Change From Baseline at Week 4 | -66.7 Percent change |
| C Propionate 2/Week | Total Severity Score (TSS): Percent Change From Baseline at Week 4 | -66.7 Percent change |
| Ketakonazol 2/Week | Total Severity Score (TSS): Percent Change From Baseline at Week 4 | -57.1 Percent change |
Comparison: 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.p-value: <0.01Cochran-Mantel-Haenszel
Comparison: 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.p-value: 0.039Cochran-Mantel-Haenszel