E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with different dermatological diseases Atopic eczema (MedDRA 6.0, LLT: 10003641) Dishydrotic hand eczema (MedDRA 6.0, LLT: 10013913) Plaque type psoriasis (MedDRA 6.0, LLT: 10050576) Seborrheic eczema (MedDRA 6.0, LLT: 10039795) Acne vulgaris (MedDRA 6.0, LLT: 10000519)
|
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040833 |
|
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 |
Clinical evaluation of the efficacy of IDEA-070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the Investigator Global Assessment score (IGA).
|
|
E.2.2 | Secondary objectives of the trial |
1.Clinical evaluation of the efficacy of IDEA-070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the following scores: a) Patient Global Assessment score (PGA) b) Indication specific scores (SCORAD, DASI, PASI, GAGS)
2.Safety of IDEA-070 evaluated by a) description of AE profile b) changes in laboratory values c) physical examination d) vital signs including body weight and body temperature e) ketoprofen plasma levels
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
One of the following dermal indications (mild to moderate): Atopic eczema in the crook of the arm or hollow of the knee Dishydrotic hand eczema Plaque type psoriasis (hyperkeratoses removed before treatment by urea or salicylic acid) Seborrheic eczema Acne vulgaris Aged 18–80 years Reliable method of contraception for women of childbearing potential
|
|
E.4 | Principal exclusion criteria |
Systemic therapy for skin diseases within 2 weeks prior to start of treatment except if maintained stable during the whole course of the study and approved by the safety officer UV therapy for dermal indications within 4 weeks prior to start of treatment Chronic or acute illness requiring systemic antiinflammatory treatment except if maintained stable during the whole course of the study and approved by the safety officer Skin cancer and precancerous skin lesions, except basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and actinic keratosis if located outside the target area History of peptic ulcers or gastric intolerance with NSAIDs History of asthma bronchiale History of chronic airway infection History of renal insufficiency Thrombocytopathia Immunosuppressants (e.g., corticosteroids) within 2 weeks prior to start of treatment Known sensitisation to NSAIDs Pregnancy or lactation Mental disorders
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the investigator global assessment using the Investigator Global Assessment SCORE (IGA)
|
|
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
|
closure of database in order to have all open questions clarified |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |