Trial | NCT00403559

Trial | NCT00403559 Report issue

Title

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

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

Phase
Phase 2

Lead Sponsor
Dermatology Specialists Research

Study Type
Interventional

Status
Completed Results Posted

Indication/Condition
Seborrheic Dermatitis

Intervention/Treatment
pimecrolimus ...
Elidel Ketoconazole Cream

Study Participants
113

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

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 Started

May 07

2007

Primary Completion

Feb 20

2009

Study Completion

Feb 27

2009

Results Posted

Mar 14

2022

Last Update

Mar 14

2022

Drug Elidel

Other names: pimecrolimus

Drug Ketoconazole Cream

Other names: Nizoral

Elidel Cream (pimecrolimus) Experimental

Elidel Cream to be applied twice daily for 4 weeks

Drug Elidel

Ketoconazole Cream (Nizoral) Active Comparator

Ketoconazole Cream to be applied twice daily for 4 weeks

Drug Ketoconazole Cream

Criteria

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

Summary

Elidel Cream

Ketoconazole Cream

All Events

Event Type	Organ System	Event Term	Elidel Cream	Ketoconazole Cream

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).

Elidel (Pimecrolimus) Cream 1% Arm

-0.9

units on a scale (Mean)

Standard Deviation: 0.8

Ketoconazole Cream 2% Arm

-0.6

units on a scale (Mean)

Standard Deviation: 0.7

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.

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