Seborrheic Dermatitis
Conditions
Keywords
seborrheic dermatitis
Brief summary
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
Detailed description
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.
Interventions
DRUGElidel
DRUGKetoconazole Cream
Sponsors
Novartis
Dermatology Specialists Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be 18 or older and sign written informed consent. * Must be wiling and able to comply with protocol. * Must have active seborrheic dermatitis of the face.
Exclusion criteria
* No history of overt bacterial, viral or fungal infection of the head/neck. * No history or presence of compromising dermatosis elsewhere on the skin * No Parkinson's disease, HIV, infections or disorders of the central nervous system * No actinically damaged skin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | One week from Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Secondary Efficacy Will be the % of Patients With Facial Clearance | 4 weeks | Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| Ketoconazole Cream 2% 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 | 56 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Elidel Cream 1% | Ketoconazole Cream 2% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 45 Participants | 90 Participants |
| Region of Enrollment United States | 56 participants | 56 participants | 112 participants |
| Sex: Female, Male Female | 17 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Male | 39 Participants | 46 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 16 / 56 | 9 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
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).
Time frame: One week from Baseline
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elidel (Pimecrolimus) Cream 1% Arm | The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | -0.9 units on a scale | Standard Deviation 0.8 |
| Ketoconazole Cream 2% Arm | The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | -0.6 units on a scale | Standard Deviation 0.7 |
p-value: 0.009Wilcoxon (Mann-Whitney)
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elidel (Pimecrolimus) Cream 1% Arm | Key Secondary Efficacy Will be the % of Patients With Facial Clearance | 56 participants |
| Ketoconazole Cream 2% Arm | Key Secondary Efficacy Will be the % of Patients With Facial Clearance | 56 participants |