E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | M15 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
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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 investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by the decrease of the Dermatophot® score from baseline to end of the study. |
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E.2.2 | Secondary objectives of the trial |
•To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of epidermal thickness with optical coherence tomography at selected centers •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of skin thickness with ultrasound at selected centers •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement epidermal thickness by 3mm punch biopsies (optional) •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of skin metabolism in suction blisters: Procollagen propeptid I and III, TGFß, Glycosaminglycan, SCCE (optional) •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by RT-PCR of the suction blister roof (optional) •To investigate the control of atopic eczema with pimecrolimus 1% cream with the Investigator’s Global Assessment (IGA)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• age 18-60 years • clinically diagnosed atopic dermatitis according to Hanifin and Rajka • local IGA (target lesions face and cubital areas): 1-3 • clinically (naked eye) evident skin atrophy due to long term topical steroid use • Dermatophot® Score (DPS) of 4-6 on at least two target areas
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E.4 | Principal exclusion criteria |
• who are in an acute major flare condition • who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks prior to study entry • who were treated with topical therapy [e.g. topical steroids, tar, pimecrolimus 1% cream, tacrolimus (Protopic®)] known or suspected to have an effect on AD within 7 days prior to study entry or who have received systemic corticosteroids (i.e., oral, intravenous, intraarticular, rectal) within 4 weeks prior to study entry. Patients on a stable maintenance dose of inhaled corticosteroids may participate • who present with clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation (e.g., generalized erythroderma such as the genetic condition Netherton’s syndrome, other skin conditions such as psoriasis) • History of malignancy of any organ system, treated or untreated whether or not there is evidence of local recurrence or metastases • Systemic immunosuppression • Clinical signs of infection in the treatment area • History of hypersensitivity to pimecrolimus 1% cream or prednicarbate 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 change of the Dermatophot score between baseline and end of study. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |