E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
•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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the mean change from baseline of the PODSI score measured at visits 2, 3 and 4. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |