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Completed

NCT Number: NCT00403559

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

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

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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elidel

Drug

Other names: pimecrolimus

Ketoconazole Cream

Drug

Other names: Nizoral

Primary outcomes

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

    Time frame: 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 outcomes

  1. Key Secondary Efficacy Will be the % of Patients With Facial Clearance

    Time frame: 4 weeks

    Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.

Sponsors and collaborators

Lead sponsor

Dermatology Specialists Research

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2006
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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