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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00403559
Other study ID # CASM981CUS37
Secondary ID SAIRB # 06-4893I
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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