Trial · NCT00403559

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

NCT00403559, Phase 2, Completed, Dermatology Specialists Research; results first posted 2022-03-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis. Trials, record NCT00403559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00403559

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
NCT number: NCT00403559
Status: Completed
Phases: Phase 2
Enrollment: 113 participants, actual
Lead sponsor: Dermatology Specialists Research
Conditions: Seborrheic Dermatitis
Interventions: Elidel, Ketoconazole Cream
First posted: 2006-11-23
Last updated: 2022-03-14
Results first posted: 2022-03-14
Limitations and caveats: Trial limitations: patient usage diaries may not have been accurate. Greater improvement may have been seen in either arm with a longer trial.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.	One week from Baseline	Per Protocol	units on a scale	MEAN
SECONDARY	Key Secondary Efficacy Will be the % of Patients With Facial Clearance	4 weeks		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.	Elidel (Pimecrolimus) Cream 1% Arm	-0.9	Standard Deviation 0.8	units on a scale
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.	Ketoconazole Cream 2% Arm	-0.6	Standard Deviation 0.7	units on a scale
Key Secondary Efficacy Will be the % of Patients With Facial Clearance	Elidel Cream (Pimecrolimus)	56		participants
Key Secondary Efficacy Will be the % of Patients With Facial Clearance	Ketoconazole Cream (Nizoral)	56		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Elidel Cream	56
Overall Study	STARTED	Ketoconazole Cream	56
Overall Study	COMPLETED	Elidel Cream	52
Overall Study	COMPLETED	Ketoconazole Cream	52
Overall Study	NOT COMPLETED	Elidel Cream	4
Overall Study	NOT COMPLETED	Ketoconazole Cream	4

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Erythema	Skin and subcutaneous tissue disorders	Elidel Cream	2	56	2
other	Erythema	Skin and subcutaneous tissue disorders	Ketoconazole Cream	0	56	0
other	Facial skin flaking	Skin and subcutaneous tissue disorders	Elidel Cream	1	56	1
other	Facial skin flaking	Skin and subcutaneous tissue disorders	Ketoconazole Cream	0	56	0
other	Burning sensation	Skin and subcutaneous tissue disorders	Elidel Cream	2	56	2
other	Burning sensation	Skin and subcutaneous tissue disorders	Ketoconazole Cream	0	56	0
other	Feeling of warmth	Skin and subcutaneous tissue disorders	Elidel Cream	3	56	3
other	Feeling of warmth	Skin and subcutaneous tissue disorders	Ketoconazole Cream	0	56	0
other	Dryness	Skin and subcutaneous tissue disorders	Elidel Cream	1	56	1
other	Dryness	Skin and subcutaneous tissue disorders	Ketoconazole Cream	0	56	0

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Elidel Cream	0	56
Total, all-cause mortality	Ketoconazole Cream	0	56
Total, other adverse events	Elidel Cream	16	56
Total, other adverse events	Ketoconazole Cream	9	56
Total, serious adverse events	Elidel Cream	0	56
Total, serious adverse events	Ketoconazole Cream	0	56

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Elidel Cream (Pimecrolimus) vs Ketoconazole Cream (Nizoral): Key Secondary Efficacy Will be the % of Patients With Facial Clearance	Trial comparisons
Elidel Cream vs Ketoconazole Cream: deaths from any cause	Trial comparisons
Elidel Cream vs Ketoconazole Cream: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00403559

GET https://conductscience.org/api/trials/v1/NCT00403559/events?page=2

API reference For AI assistants