A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

• Sponsor: Dermatology Specialists Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00403559
• Collaborator: Novartis (Industry)
• Enrollment: 113
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Condition or Disease	Intervention/Treatment	Phase
Seborrheic Dermatitis	Drug: Elidel; Drug: Ketoconazole Cream	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
• Actual Study Start Date: May 7, 2007
• Actual Primary Completion Date: Feb 20, 2009
• Actual Study Completion Date: Feb 27, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elidel Cream (pimecrolimus) Elidel Cream to be applied twice daily for 4 weeks	Drug: Elidel; Other Names: pimecrolimus
Active Comparator: Ketoconazole Cream (Nizoral) Ketoconazole Cream to be applied twice daily for 4 weeks	Drug: Ketoconazole Cream; Other Names: Nizoral

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Specialists	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• Dermatology Specialists Research
• Novartis

Investigators

• Principal Investigator: Steven Kempers, MD, Associated Skin Care Specialists
• Principal Investigator: Bernard Goffe, MD, Dermatology Associates
• Principal Investigator: Debra Breneman, MD, University of Cincinnati - Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dermatology Specialists Research
• ClinicalTrials.gov Identifier: NCT00403559
• Other Study ID Numbers: CASM981CUS37; SAIRB # 06-4893; IND 75,225
• First Posted: Nov 23, 2006
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dermatology Specialists Research: seborrheic dermatitis
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Seborrheic; Ketoconazole; Pimecrolimus

Study Results

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 Detail

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.

Arm/Group Title	Elidel Cream	Ketoconazole Cream
Arm/Group Description	Participants randomly assigned Elidel Cream twice daily for four weeks.	Participants randomly selected to apply Ketoconazole Cream twice daily for 4 weeks.
Period Title: Overall Study
STARTED	56	56
COMPLETED	52	52
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Elidel Cream 1%	Ketoconazole Cream 2%	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	56	56	112
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	45 80.4%	45 80.4%	90 80.4%
>=65 years	11 19.6%	11 19.6%	22 19.6%
Sex: Female, Male (Count of Participants)
Female	17 30.4%	10 17.9%	27 24.1%
Male	39 69.6%	46 82.1%	85 75.9%
Region of Enrollment (participants) [Number]
United States	56 100%	56 100%	112 100%

Outcome Measures

1. Primary Outcome

Title	The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
Description	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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Elidel (Pimecrolimus) Cream 1% Arm	Ketoconazole Cream 2% Arm
Arm/Group Description	The Change in F-IGA from BL to Wk 1 assigned Elidel Cream (pimecrolimus) 1%	The Change in F-IGA from BL to Wk 1 assigned Ketoconazole Cream 2%
Measure Participants	56	56
Mean (Standard Deviation) [units on a scale]	-0.9 (0.8)	-0.6 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Elidel (Pimecrolimus) Cream 1% Arm, Ketoconazole Cream 2% Arm
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.
Statistical Test of Hypothesis	p-Value	.009
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Key Secondary Efficacy Will be the % of Patients With Facial Clearance
Description	Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Elidel Cream (Pimecrolimus)	Ketoconazole Cream (Nizoral)
Arm/Group Description	Elidel Cream to be applied twice daily for 4 weeks Elidel	Ketoconazole Cream to be applied twice daily for 4 weeks Ketoconazole Cream
Measure Participants	56	56
Number [participants]	56 100%	56 100%

Adverse Events

Time Frame	4 weeks per subject, Baseline to End of Study
Adverse Event Reporting Description	Definitions as per www.ClinicalTrials.gov
Arm/Group Title	Elidel Cream		Ketoconazole Cream
Arm/Group Description	Elidel (pimecrolimus) Cream 1% Arm		Ketoconazole Cream 2% Arm
All Cause Mortality
	Elidel Cream		Ketoconazole Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Serious Adverse Events
	Elidel Cream		Ketoconazole Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Elidel Cream		Ketoconazole Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/56 (28.6%)		9/56 (16.1%)
Ear and labyrinth disorders
Loss of Balance	0/56 (0%)	0	1/56 (1.8%)	1
Endocrine disorders
Hypothyroidism	1/56 (1.8%)	1	0/56 (0%)	0
Eye disorders
Dry Eyes	1/56 (1.8%)	1	0/56 (0%)	0
Gastrointestinal disorders
Indigestion	1/56 (1.8%)	1	0/56 (0%)	0
General disorders
Sinusitis	0/56 (0%)	0	1/56 (1.8%)	1
Headache	0/56 (0%)	0	1/56 (1.8%)	1
Infections and infestations
Common Cold	1/56 (1.8%)	1	2/56 (3.6%)	2
Sore throat	0/56 (0%)	0	1/56 (1.8%)	1
Urinary Tract Infection	1/56 (1.8%)	1	0/56 (0%)	0
Injury, poisoning and procedural complications
Domestic animal bite	1/56 (1.8%)	1	0/56 (0%)	0
Musculoskeletal and connective tissue disorders
Fracture	1/56 (1.8%)	1	1/56 (1.8%)	1
Muscular Ache	1/56 (1.8%)	1	0/56 (0%)	0
Pain Left Shoulder	0/56 (0%)	0	1/56 (1.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal mass	1/56 (1.8%)	1	0/56 (0%)	0
Prostate Cancer	1/56 (1.8%)	1	0/56 (0%)	0
Psychiatric disorders
Depression	1/56 (1.8%)	1	0/56 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	2/56 (3.6%)	2	0/56 (0%)	0
Facial skin flaking	1/56 (1.8%)	1	0/56 (0%)	0
Burning sensation	2/56 (3.6%)	2	0/56 (0%)	0
Feeling of warmth	3/56 (5.4%)	3	0/56 (0%)	0
Dryness	1/56 (1.8%)	1	0/56 (0%)	0
Pruritus	1/56 (1.8%)	1	0/56 (0%)	0
Dermatitis	1/56 (1.8%)	1	0/56 (0%)	0
Sunburn	0/56 (0%)	0	1/56 (1.8%)	1
Nodular basal cell carcinoma	1/56 (1.8%)	1	0/56 (0%)	0
Urticaria	1/56 (1.8%)	1	0/56 (0%)	0

Limitations/Caveats

Trial limitations: patient usage diaries may not have been accurate. Greater improvement may have been seen in either arm with a longer trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.