Trial Outcomes & Findings for A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis (NCT NCT00403559)
NCT ID: NCT00403559
Last Updated: 2022-03-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
One week from Baseline
Results posted on
2022-03-14
Participant Flow
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.
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.
Participant milestones
| Measure |
Elidel Cream
Participants randomly assigned Elidel Cream twice daily for four weeks.
|
Ketoconazole Cream
Participants randomly selected to apply Ketoconazole Cream twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Elidel Cream
Participants randomly assigned Elidel Cream twice daily for four weeks.
|
Ketoconazole Cream
Participants randomly selected to apply Ketoconazole Cream twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Baseline characteristics by cohort
| Measure |
Elidel Cream 1%
n=56 Participants
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
|
Ketoconazole Cream 2%
n=56 Participants
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
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week from BaselinePopulation: Per Protocol
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).
Outcome measures
| Measure |
Elidel (Pimecrolimus) Cream 1% Arm
n=56 Participants
The Change in F-IGA from BL to Wk 1 assigned Elidel Cream (pimecrolimus) 1%
|
Ketoconazole Cream 2% Arm
n=56 Participants
The Change in F-IGA from BL to Wk 1 assigned Ketoconazole Cream 2%
|
|---|---|---|
|
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
|
-0.6 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 4 weeksNumber of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.
Outcome measures
| Measure |
Elidel (Pimecrolimus) Cream 1% Arm
n=56 Participants
The Change in F-IGA from BL to Wk 1 assigned Elidel Cream (pimecrolimus) 1%
|
Ketoconazole Cream 2% Arm
n=56 Participants
The Change in F-IGA from BL to Wk 1 assigned Ketoconazole Cream 2%
|
|---|---|---|
|
Key Secondary Efficacy Will be the % of Patients With Facial Clearance
|
56 participants
|
56 participants
|
Adverse Events
Elidel Cream
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Ketoconazole Cream
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elidel Cream
n=56 participants at risk
Elidel (pimecrolimus) Cream 1% Arm
|
Ketoconazole Cream
n=56 participants at risk
Ketoconazole Cream 2% Arm
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
2/56 • Number of events 2 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Facial skin flaking
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
3.6%
2/56 • Number of events 2 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Feeling of warmth
|
5.4%
3/56 • Number of events 3 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dryness
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Infections and infestations
Common Cold
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
3.6%
2/56 • Number of events 2 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Infections and infestations
Sore throat
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscular Ache
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
General disorders
Sinusitis
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Domestic animal bite
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal mass
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Gastrointestinal disorders
Indigestion
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Nodular basal cell carcinoma
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
General disorders
Headache
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Eye disorders
Dry Eyes
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Loss of Balance
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain Left Shoulder
|
0.00%
0/56 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
1.8%
1/56 • Number of events 1 • 4 weeks per subject, Baseline to End of Study
Definitions as per www.ClinicalTrials.gov
|
Additional Information
Joseph F. Fowler, Jr., M.D.
Dermatology Specialists, PSC
Phone: 502-583-7546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place