Escape: Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT00862654
Collaborator
(none)
326
18
4
11.1
18.1
1.6
Study Details
Study Description
Brief Summary
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Feb 1, 2010
Actual Study Completion Date
:
Feb 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: C propionate 4/week + Ketoconasole 2/week Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) |
Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
|
| Experimental: C propionate 2/week + Ketoconasole 2/week Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) |
Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
|
| Experimental: C propionate 2/week Clobetasol propionate shampoo 0.05% (2/week) |
Drug: clobetasol propionate shampoo (2/week)
Monotherapy with clobetasol propionate shampoo
|
| Active Comparator: Ketoconazole 2/week Ketoconazole shampoo 2% (2/week) |
Drug: ketoconazole shampoo (2/week)
Monotherpay ketoconazole shampoo (2/week)
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Galderma Investigational Center | Brugge | Belgium | ||
| 2 | Galderma Investigational Center | Bruxelles | Belgium | ||
| 3 | Galderma Investigational Center | Geel | Belgium | ||
| 4 | Galderma Investigational Center | Gent | Belgium | ||
| 5 | Galderma Investigational Center | Liege | Belgium | ||
| 6 | Galderma Investigational Center | Mons | Belgium | ||
| 7 | Galderma Investigational Center | Paris | France | ||
| 8 | Galderma Investigational Center | Berlin | Germany | ||
| 9 | Galderma Investigational Center | Bonn | Germany | ||
| 10 | Galderma Investigational Center | Hamburg | Germany | ||
| 11 | Galderma Investigational Center | Lubeck | Germany | ||
| 12 | Galderma Investigational Center | Mahlow | Germany | ||
| 13 | Galderma Investigational Center | Wuppertal | Germany | ||
| 14 | Galderma Investigational Center | Seoul | Korea, Republic of | ||
| 15 | Galderma Investigational Center | Guadalajara | Mexico | ||
| 16 | Galderma Investigational Center | Mexico | Mexico | ||
| 17 | Galderma Investigational Center | Naucalpan | Mexico | ||
| 18 | Galderma Investigational Center | Zapopan, Jalisco | Mexico |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: Jean-Paul Ortonne, MD, Nice Hospital (France)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT00862654
Other Study ID Numbers:
- RD.03.SPR.29079
First Posted:
Mar 17, 2009
Last Update Posted:
Feb 18, 2021
Last Verified:
Aug 1, 2011
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|
| Arm/Group Description | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) | Ketoconazole shampoo 2% (2/week) |
| Period Title: Overall Study | ||||
| STARTED | 82 | 82 | 82 | 80 |
| COMPLETED | 76 | 74 | 76 | 74 |
| NOT COMPLETED | 6 | 8 | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) | Ketoconazole shampoo 2% (2/week) | Total of all reporting groups |
| Overall Participants | 82 | 82 | 82 | 80 | 326 |
| Age (Count of Participants) | |||||
| <=18 years |
2
2.4%
|
1
1.2%
|
3
3.7%
|
1
1.3%
|
7
2.1%
|
| Between 18 and 65 years |
65
79.3%
|
69
84.1%
|
71
86.6%
|
66
82.5%
|
271
83.1%
|
| >=65 years |
15
18.3%
|
12
14.6%
|
8
9.8%
|
13
16.3%
|
48
14.7%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
46.9
(16.0)
|
43.8
(17.2)
|
44.9
(15.3)
|
44.7
(15.5)
|
45.1
(16.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
36
43.9%
|
39
47.6%
|
38
46.3%
|
36
45%
|
149
45.7%
|
| Male |
46
56.1%
|
43
52.4%
|
44
53.7%
|
44
55%
|
177
54.3%
|
| Region of Enrollment (participants) [Number] | |||||
| France |
12
14.6%
|
11
13.4%
|
12
14.6%
|
12
15%
|
47
14.4%
|
| Mexico |
17
20.7%
|
18
22%
|
18
22%
|
17
21.3%
|
70
21.5%
|
| Belgium |
9
11%
|
7
8.5%
|
9
11%
|
8
10%
|
33
10.1%
|
| Germany |
35
42.7%
|
37
45.1%
|
34
41.5%
|
34
42.5%
|
140
42.9%
|
| Korea, Republic of |
9
11%
|
9
11%
|
9
11%
|
9
11.3%
|
36
11%
|
Outcome Measures
| Title | Total Severity Score (TSS): Percent Change From Baseline at Week 4 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent To Treat (ITT) with Last Observation Carried Forward (LOCF) |
| Arm/Group Title | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|
| Arm/Group Description | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) | Ketoconazole shampoo 2% (2/week) |
| Measure Participants | 82 | 82 | 82 | 80 |
| Median (Full Range) [Percent change] |
-71.4
|
-66.7
|
-66.7
|
-57.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | C Propionate 2/Week + Ketoconazole 2/Week, Ketakonazol 2/Week |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Each test was two-sided, at the 0.050 significance level. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | C Propionate 2/Week, Ketakonazol 2/Week |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Each test was two-sided, at the 0.050 significance level. | |
Adverse Events
| Time Frame | During the study - 12 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | ||||
| Arm/Group Description | Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | Clobetasol propionate shampoo 0.05% (2/week) | Ketoconazole shampoo 2% (2/week) | ||||
All Cause Mortality |
||||||||
| C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/82 (1.2%) | 0/82 (0%) | 1/82 (1.2%) | 0/80 (0%) | ||||
| Cardiac disorders | ||||||||
| ANGINA PECTORIS | 1/82 (1.2%) | 1 | 0/82 (0%) | 0 | 0/82 (0%) | 0 | 0/80 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| UPPER LIMB FRACTURE | 0/82 (0%) | 0 | 0/82 (0%) | 0 | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/82 (18.3%) | 18/82 (22%) | 17/82 (20.7%) | 16/80 (20%) | ||||
| Infections and infestations | ||||||||
| Dengue fever | 0/82 (0%) | 0 | 0/82 (0%) | 0 | 2/82 (2.4%) | 2 | 0/80 (0%) | 0 |
| Influenza | 3/82 (3.7%) | 3 | 4/82 (4.9%) | 4 | 2/82 (2.4%) | 2 | 1/80 (1.3%) | 1 |
| Nasopharyngitis | 5/82 (6.1%) | 6 | 4/82 (4.9%) | 4 | 7/82 (8.5%) | 7 | 5/80 (6.3%) | 7 |
| Pharyngitis | 2/82 (2.4%) | 3 | 1/82 (1.2%) | 1 | 2/82 (2.4%) | 2 | 2/80 (2.5%) | 2 |
| Respiratory Tract Infection | 1/82 (1.2%) | 1 | 2/82 (2.4%) | 2 | 0/82 (0%) | 0 | 1/80 (1.3%) | 1 |
| Rhinitis | 0/82 (0%) | 0 | 1/82 (1.2%) | 1 | 1/82 (1.2%) | 1 | 2/80 (2.5%) | 2 |
| Sinusitis | 1/82 (1.2%) | 1 | 0/82 (0%) | 0 | 0/82 (0%) | 0 | 2/80 (2.5%) | 2 |
| Nervous system disorders | ||||||||
| Headache | 0/82 (0%) | 0 | 2/82 (2.4%) | 2 | 0/82 (0%) | 0 | 2/80 (2.5%) | 3 |
| Reproductive system and breast disorders | ||||||||
| Dymenorrhoea | 2/82 (2.4%) | 3 | 0/82 (0%) | 0 | 0/82 (0%) | 0 | 0/80 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis Acneiform | 1/82 (1.2%) | 1 | 1/82 (1.2%) | 1 | 2/82 (2.4%) | 2 | 1/80 (1.3%) | 1 |
| Pruritus | 0/82 (0%) | 0 | 3/82 (3.7%) | 4 | 1/82 (1.2%) | 1 | 0/80 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Farzi Sidou, Clinical Project Manager |
|---|---|
| Organization | Galderma |
| Phone | +33 4 93 95 70 51 |
| farzaneh.sidou@galderma.com |
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT00862654
Other Study ID Numbers:
- RD.03.SPR.29079
First Posted:
Mar 17, 2009
Last Update Posted:
Feb 18, 2021
Last Verified:
Aug 1, 2011