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 |
Primary objective: To document the safety profile of ASF 1057 cream 0.5% when used for up to 12 months in the treatment of seborrhoeic dermatitis patients.
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E.2.2 | Secondary objectives of the trial |
- To describe number of patient discontinuations and the reasons for discontinuations, – To determine exposure time to ASF 1057 cream 0.5% per patient, – To determine the frequency of treatment courses (i.e., 3 weeks of treatment with ASF 1057 cream 0.5%, will be counted per eligible location of occurrence) of seborrhoeic dermatitis symptoms during long term use of ASF 1057, – To determine the proportion of successful treatment courses (the entire area to be treated has responded to treatment, i.e., OSS ≤ 1 score units) on the face, – To determine the proportion of successful treatment courses on the chest and upper back, – To measure the effect of ASF 1057 on recurring seborrhoeic dermatitis symptoms over time as determined by OSS and Dermatology Life Quality Index (DLQI).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent, 2. Completion of Trial ASF 1057 301 as documented on the End of Trial status page in the case report form (CRF). 3. Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a medically accepted contraceptive method (and agree to use it during the trial) such as: - Systemic contraceptive (oral, implant, injection), - Diaphragm or cervical cap with intravaginal spermicide, - Intrauterine device, or - Condom with intravaginal spermicide. In Denmark and Germany, the patients must agree to continue their contraception during the trial and for 1 month after the end of the trial. 4. Willingness and ability to comply with the trial procedures.
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E.4 | Principal exclusion criteria |
1. Female patients who are pregnant or breast-feeding, 2. Known allergy to any of the constituents of the product being tested, 3. Known immunosuppressive (e.g., AIDS/HIV) or neurological diseases (e.g., Parkinson or MS), 4. Presence of an other serious or progressive disease which, according to the Investigator may interfere with treatment outcome, 5. Active skin disease such as psoriasis, atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome, 6. Intention to use topical medical treatment in the area to be treated within the next 12 months, e.g., anti inflammatory (e.g., corticosteroids, non-steroidal anti inflammatory drugs [NSAIDs]), coal tar preparations, anti-seborrhoeic preparations, antihistamines, antibiotics, or antifungal medications, 7. Intention to use of other topical pharmaceutical products on the area to be treated during treatment period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence and severity of AEs and adverse drug reactions (ADRs). |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |