perioral dermatitis
Conditions
Interventions
Trade Name: Elidel 1% Creme
Product Name: Elidel 1% Creme
Pharmaceutical Form: Cream
INN or Proposed INN: Pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Concentration unit: % percen
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •Concomitant skin disease in the study area that could interfere with evaluation of PD •Clinical signs of infection in the treatment area •History of hypersensitivity to pimecrolimus or to drugs with similar chemical structures and/or to any other ingredients of the formulation •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Females of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, IUDs, but also abstinence at the discretion of the investigator. •Use of other investigational drugs within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of pimecrolimus cream 1% in patients with perioral dermatitis, by testing the hypothesis that pimecrolimus cream 1% is superior in the mean reduction of the PODSI score (Perioral Dermatitis Severity Index) at weeks 1, 2 and 4 of treatment compared to its vehicle. ;Secondary Objective: •To investigate the time to disease recurrence. Disease recurrence is defined as an increase in PODSI by > 50% of the PODSI decrease from baseline. •To assess the time to response. Response is defined as a decrease in PODSI by >= 50% of the baseline value. •To determine the responder rates at weeks 1, 2 and 4 and in the follow-up period. •To evaluate the effect of pimecrolimus on the patients’ quality of life as compared to its vehicle by using the Dermatology Life Quality Index after Finlay. •To evaluate the effect of pimecrolimus on the patients’ subjective perception of disease severity as compared to its vehicle by using a visual analogue scale. •To determine the Investigators’ Global Assessment of disease severity at all visits ;Primary end point(s): The primary endpoint is the mean change from baseline of the PODSI score measured at visits 2, 3 and 4. | — |
Countries
Germany
Outcome results
None listed