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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003000-12 | EudraCT Number | ||
| U1111-1133-6455 | Registry Identifier | UTN (WHO) |
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The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5% Roflumilast Cream | Experimental | Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. |
|
| Vehicle Cream | Placebo Comparator | Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Roflumilast Cream | Drug | Roflumilast 0.5% cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD) | Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity. | Baseline and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values | Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements. | Baseline and Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
Participants with a historical diagnosis of Atopic Dermatitis were enrolled in 1 of 2 twice daily (BID) treatment groups.
Participants took part in the study at 3 centers in Germany from 10 June 2013 to 18 March 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% Roflumilast Cream | Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. |
| FG001 | Vehicle Cream | Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% Roflumilast Cream | Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. |
| BG001 | Vehicle Cream | Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD) | Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity. | All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Day 15 |
|
From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22)
The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
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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 | 0.5% Roflumilast Cream | Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Vehicle Cream |
| Drug |
Roflumilast formulation vehicle |
|
| Change From Baseline to Day 15 in Participants' Assessment of Pruritus |
Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms. |
| Baseline and Day 15 |
| Gera |
| Germany |
| Hamburg | Germany |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Classificaiton | Number | participants |
|
| Female Reproductive Status | Number | participants |
|
| Baseline Modified Local SCORing Atopic Dermatitis (SCORAD) | Mean | Full Range | scores on a scale |
|
| Baseline Transepidermal Water Loss (TEWL) Mean | Mean | Full Range | g/m^2/hr |
|
| Baseline Participant Assessment of Pruritis | Mean | Full Range | scores on a scale |
|
| Vehicle Cream |
Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. |
|
|
|
| Secondary | Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values | Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements. | All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data. | Posted | Least Squares Mean | Standard Error | g/m^2/hr | Baseline and Day 15 |
|
|
|
|
| Secondary | Change From Baseline to Day 15 in Participants' Assessment of Pruritus | Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms. | All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Day 15 |
|
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Vehicle Cream | Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days. | 0 | 20 | 3 | 20 |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Red blood cells urine | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |