E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
dermatitis atópica
(atopic dermatitis) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012438 |
E.1.2 | Term | Dermatitis atopic |
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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 determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; - to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.
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E.2.2 | Secondary objectives of the trial |
- to determine the systemic exposure to and urinary excretion of ImCOOH after topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; - to determine the endogenous exposure to and urinary excretion of ImCOOH.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female aged between 18 and 70 years, extremes included. 2. Skin type I, II, III, or IV. 3. Able to comply with protocol requirements. 4. Informed Consent Form (ICF) signed voluntarily before the first trial-related activity. 5. Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection. 6. Normal weight as defined by a Quetelet Index (Body Mass Index [BMI]: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included. 7. Patients having atopic dermatitis according to the integrated list with criteria for atopic dermatitis. 8. Comparative target areas: minimum 0.1% and maximum 2% of the total body surface area per target area with one site at the left limb and one site at the right limb. Both target areas should be located at the arms (armpits [axillas] are also allowed) or both target areas should be located at the hollows of the knee. 9. Topical Atopic Dermatitis Severity Index (toADSI) score of at least 5 for both target areas and the severity of the 2 sites does not differ by more than 3 points. 10. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
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E.4 | Principal exclusion criteria |
1. Female subject of childbearing potential without use of effective birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period; Note: Estrogen based hormonal contraception may not be reliable when ImCOOH cream is applied, therefore to be eligible for this trial, women of childbearing potential should either: a. use a double barrier method to prevent pregnancy (i.e., using a condom with either diaphragm or cervical cap); b. use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); c. use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom); d. be only non-heterosexually active, practice heterosexual abstinence, or have a vasectomized partner (confirmed sterile). Women with tubal ligation are required to use 1 non-hormonal contraceptive method. Women who are postmenopausal for at least 2 years, and women with total hysterectomy are considered of non-childbearing potential. 2. A positive pregnancy test or breast feeding at screening. 3. A positive HIV-1 or -2 test at trial screening. 4. Hepatitis B infection (confirmed by hepatitis B surface antigen) or hepatitis C infection (confirmed by hepatitis C virus antibody) at trial screening. 5. Having a target area that is hairy in such extent that in the investigator’s opinion it could influence the application. 6. Having a target area that is tattooed. 7. Unable to take venous blood samples for pharmacokinetics (PK) outside the elbow fold (fossa cubitus) area in case both elbow folds are part of the target areas. 8. Patients receiving radiation therapy, systemic therapy with cytostatics or immunosuppressive drugs within 24 weeks before the first application of trial medication. 9. Patients receiving phototherapy or systemic therapy for atopic dermatitis within 4 weeks before the first application of trial medication. 10. Patients receiving antibiotics or topical therapy for atopic dermatitis within 2 weeks before the first application of trial medication. However, once-daily use of 1% hydrocortisone acetate is allowed on all lesions with the exception of the test sites and emollients are allowed to be used liberally but not on the test sites. 11. Patients taking antihistamines within 1 week before the first application of trial medication. 12. Patients with any acute skin infection (superinfection or secondary impetiginisation). 13. Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the patient safety or compliance with trial procedures. 14. Any history or currently active allergy such as but not limited to drug allergy, food allergy or hay fever. 15. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the trial medication administered in this trial. 16. Participation in an investigational drug trial within 30 days prior to the first application of trial medication. 17. Donation of blood or plasma in the 60 days preceding the first application of trial medication. 18. Patients with the following laboratory abnormalities at screening: • serum creatinine > 1.1 x ULN; • hemoglobin ≤ 10.9 g/dL; • platelet count grade ≤ 125 x 109/L; • absolute neutrophil count ≤ 1.3 x 109/L; • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.25 x ULN; • total bilirubin ≥ 1.1 x ULN; • proteinuria or hematuria; • any other moderate or severe laboratory abnormality.
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy, safety, tolerability and pharmacokinetics |
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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 | Yes |
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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
left-right limb comparison |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |