Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-07-31

Brief Summary

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An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.

This study is not enrolling patients in the United States.

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Detailed Description

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Conditions

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Perioral Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Pimecrolimus

Group Type EXPERIMENTAL

Pimecrolimus

Intervention Type DRUG

Pimecrolimus cream 1 %

2

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle cream (placebo)

Interventions

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Pimecrolimus

Pimecrolimus cream 1 %

Intervention Type DRUG

Placebo

Vehicle cream (placebo)

Intervention Type DRUG

Other Intervention Names

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Elidel

Eligibility Criteria

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Inclusion Criteria

* clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
* minimum severity score (PODSI) ≥ 4
* age 18 and older

Exclusion Criteria

* Ongoing use of the following treatments is NOT allowed after the start of study drug:

Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).

* Systemic immunosuppression
* History of malignancy of any organ system, treated or untreated, within the past 5 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No