Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SAIRB # 06-4893 | Other Identifier | DematologySR | |
| IND 75,225 | Other Identifier | DematologySR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elidel Cream (pimecrolimus) | Experimental | Elidel Cream to be applied twice daily for 4 weeks |
|
| Ketoconazole Cream (Nizoral) | Active Comparator | Ketoconazole Cream to be applied twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elidel | Drug |
|
| |
| Ketoconazole Cream |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas). | One week from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Efficacy Will be the % of Patients With Facial Clearance | Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance. | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Kempers, MD | Associated Skin Care Specialists | Principal Investigator |
| Bernard Goffe, MD | Dermatology Associates | Principal Investigator |
| Debra Breneman, MD | University of Cincinnati - Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
Consented subjects who had been using topical medication for their seborrheic dermatitis, underwent withdrawal from this treatment (washout) for 2 weeks prior to being randomized and beginning use of study product. One subject after undergoing washout did not qualify for randomization due to not meeting disease severity criteria. This subject was not included in the total number of subjects who started the study.
Enrollment began in May 2007. All subject visits were completed by Feb. 2009. There were 4 research sites, all part of dermatology practices. Subjects were recruited from the patient population of each site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Elidel Cream | Participants randomly assigned Elidel Cream twice daily for four weeks. |
| FG001 | Ketoconazole Cream | Participants randomly selected to apply Ketoconazole Cream twice daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Elidel Cream 1% | In a randomized fashion, fifty six participants with facial seborrheic dermatitis were assigned to Elidel Cream 1% (pimecrolimus) to be applied twice daily for 4 weeks |
| BG001 | Ketoconazole Cream 2% |
| 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 | The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas). | Per Protocol | Posted | Mean | Standard Deviation | units on a scale | One week from Baseline |
|
4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elidel Cream | Elidel (pimecrolimus) Cream 1% Arm | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Facial redness |
Trial limitations: patient usage diaries may not have been accurate. Greater improvement may have been seen in either arm with a longer trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph F. Fowler, Jr., M.D. | Dermatology Specialists, PSC | 502-583-7546 | 184 | fowlerjoe@msn.com |
Not provided
| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C117268 | pimecrolimus |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Withdrawal by Subject |
|
n a randomized fashion, fifty six participants with facial seborrheic dermatitis were assigned to Ketoconazole Cream 2% to be applied twice daily for 4 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ketoconazole Cream 2% Arm | The Change in F-IGA from BL to Wk 1 assigned Ketoconazole Cream 2% |
|
|
|
| Secondary | Key Secondary Efficacy Will be the % of Patients With Facial Clearance | Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance. | Posted | Number | participants | 4 weeks |
|
|
|
| 56 |
| 0 |
| 56 |
| 16 |
| 56 |
| EG001 | Ketoconazole Cream | Ketoconazole Cream 2% Arm | 0 | 56 | 0 | 56 | 9 | 56 |
|
| Facial skin flaking | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Area of study medication application |
|
| Burning sensation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Immediate burning sensation upon application of study medication, resolves within 15 minutes |
|
| Feeling of warmth | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Site application had a sensation of warmth |
|
| Dryness | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Facial skin dry at area of study medication application |
|
| Common Cold | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Symptoms of nasal congestion and excessive drainage during course. |
|
| Sore throat | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Fracture of lower extremity bones |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Area of study medication application |
|
| Muscular Ache | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Domestic animal bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rectal mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Rash not at study medication application site |
|
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sunburn | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nodular basal cell carcinoma | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry Eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Loss of Balance | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Hive on non study medication application site |
|
| Pain Left Shoulder | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |