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

Phase 2

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: Ketoconazole Cream; Drug: Elidel

• Registration Number: NCT00403559
• Lead Sponsor: Dermatology Specialists Research

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.

Study Timeline

• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Study Start: 2007-05-07
• Primary Completion: 2009-02-20
• Study Completion: 2009-02-27
• Results First Submitted: 2013-11-22
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-11
• Results First Posted: 2022-03-14
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoconazole Cream (Nizoral)	Ketoconazole Cream	Ketoconazole Cream to be applied twice daily for 4 weeks
Elidel Cream (pimecrolimus)	Elidel	Elidel Cream to be applied twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Dermatology Specialists; 🇺🇸 Louisville, Kentucky, United States