E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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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 compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate atopic dermatitis |
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E.2.2 | Secondary objectives of the trial |
To assess the safety, tolerability and the bioavailability of three doses of topically applied DGLA cream, versus placebo, in patients with mild to moderate atopic dermatitis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Clinically confirmed diagnosis of active atopic dermatitis according to Hanifin and Rajka criteria.
2.Patients with mild to moderate atopic dermatitis at screening; Rajka-Langeland score 3-7.5.
3. Patients with mild to moderate atopic dermatitis covering 2-50% of the body surface area
4.Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
5.Patients in general good health as confirmed by a physical examination and by medical history.
6.Patients who are able and willing to give signed informed consent (ICF).
7.Patient’s body mass index (BMI) is between 18 and 30 kg/m2 inclusive.
8.Female patients of child bearing potential, and female partners of male patients, must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) for the duration of the study; or agree to sexual abstinence for the duration of the study. Note: women of non-child bearing potential are:
- women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation)
- women greater than 60 years of age, or
- women greater than 40 and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH≥40 mlU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
9.Patients who are able and willing to stop treatment for atopic dermatitis for the washout period (except emollients).
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E.4 | Principal exclusion criteria |
1.Females with positive pregnancy test at screening (Visit 1) or start of treatment/baseline (Visit 2) or lactating women.
2.Patients who have received phototherapy (UVA, UVB) within 4 weeks of screening (Visit 1).
3.Patients with Netherton’s Syndrome.
4.Patients with clinically significant impairment of renal or hepatic function.
5.Patients with other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis, viral, bacterial and fungal skin infections).
6.Patients with a history of hypersensitivity to any substance in the IMP.
7.Patients with severe atopic dermatitis; Rajka-Langeland score 8-9.
8.Patients with a history of clinically relevant ECG abnormalities
9.Patients treated with any experimental drug within 30 days prior to start of treatment/baseline visit (Visit 2).
10.Patients who have used any of the medications and therapeutic regimens excluded from the study within 14 days prior to baseline/day 0 visit (Visit 2).
11.Patients with a significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease.
12.Patients with a medical history of chronic infectious disease (HCV, HBV, HIV).
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change in modified Eczema Area and Severity Index (mEASI) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14 and 21 days.
Change in Investigator’s Global Assessment (IGA) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
Change in the patient’s VAS pruritus score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
Change in the Patient Orientated Eczema Measure (POEM) from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
Change in the Dermatology Life Quality Index (DLQI) score from screening visit (visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days. |
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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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 14 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 14 |