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

Seborrheic Dermatitis Clinical Trial

Official title:

A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403559
• Other study ID #: CASM981CUS37
• Secondary ID: SAIRB # 06-4893I
• Status: Completed
• Phase: Phase 2
• Start date: May 7, 2007
• Est. completion date: February 27, 2009

Study information

• Verified date: March 2022
• Source: Dermatology Specialists Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: February 27, 2009
• Est. primary completion date: February 20, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• Elidel

• Ketoconazole Cream

Locations

Country	Name	City	State
United States	Dermatology Specialists	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Dermatology Specialists Research	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	One week from Baseline
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.	4 weeks