| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 | 10003639 |
| E.1.2 | Term | Atopic dermatitis |
|
| 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 explore the clinical efficacy of UR-1505 (0,5%, 1% and 2%) applied once daily during 4 weeks, compared with a vehicle without active ingredients and with an active treatment, in adult patients with mild to moderate atopic dermatitis. |
|
| E.2.2 | Secondary objectives of the trial |
To explore the dose response relationship of three growing concentrations of UR-1505 ointment.
To explore safety and local tolerability of the experimental treatments.
To explore the global evaluation of each formulation.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
·Sex: Male or female
·Age: older than 18 and less than 65 years.
·Phototype: I to IV according to the Fitzpatrick
·Patient volunteer, with mild to moderate atopic dermatitis according to the UK Working Party's Diagnostic Criteria for Atopic Dermatitis:
- Evidence of itchy skin plus 3 or more of the following criteria:
- History of involvement of the skin creases (e.g., fronts of elbows, backs
of knees, fronts of ankles and areas around the neck or eyes)
- History of asthma or hay fever
- History of generally dry skin in the past year
- Onset under two years of age
- Visible flexural dermatitis
· SCORAD value between 8 and 30
· Patient with at least two atopic dermatitis areas on equivalent topographic areas (arms, legs or trunk).
· The sum of the size of each of the 2 areas selected and treated will not exceed 20% of the body.
· For woman with child-bearing potential: use of a known, effective means of contraception (contraceptive pills, intra-uterine contraceptive device, tromp phallop ligation, implants or condom) for at least 12 weeks prior to the study, during the study and one month after the end of the study.
· Subject being psychologically able to understand information and to give his/her consent.
· Subject having given freely and expressly his/her informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
· Subject affiliated to a health social security system.
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|
| E.4 | Principal exclusion criteria |
· Subject with a loss of personal liberty, by administrative or judicial decision.
· Minor or major with a legal guardian.
· Subject in a social or sanitary establishment.
· Subject in an emergency situation.
· Volunteer having been paid more than 4500€ to take part in biomedical researches over the previous 12 months.
· Pregnant or nursing woman or planning to be pregnant during the study.
· Subject likely to be non observant to the study according to the investigator interpretation.
· Patient registered as being in exclusion period in the French Health Minister File of Patients.
· Subject suffering from a serious or progressive disease(s) that the investigator judges may interfere with the study.
· Subject with a congenital or established immunity defect.
· Subject with potentially malign or pre cancerous lesions.
· Subject having a cutaneous pathology on the test zones except the atopic dermatitis.
· Subject clinical sign of infection on the test zones.
· Presence of active infection with Herpes virus (Herpes simplex dermite, labial Herpes, eruption of Kaposi varicelliforme).
· Subject with a lymphadenopathy.
· Subject who want to plan a vaccination during the study and four weeks after the study (potential risk of failure of the vaccination).
· Subject with know allergy or hypersensitivity to a constituent of the products (in particular to salicylic compounds or any of substances used as a vehicle), as well as allergy or hypersensitivity reactions to Tacrolimus ointment 0.1% or macrolides (antibiotics).
· Subject with any other skin disease that makes implementation of the protocol or interpretation of the study results difficult at investigator criteria.
· History of erythrodermic, extensive (more than 20% of the body surface) or pustular atopic dermatitis.
· Subject with necessity of other treatment than emollients (like dermocorticoid) on the lesions of atopic dermatitis not studied.
· Use of any topical atopic dermatitis therapy in selected areas within two weeks of the study entry and during the study.
· Use of any systemic atopic dermatitis therapy (including phototherapy) within 8 weeks prior to the study entry and during the study.
· Subject receiving topical or systemic medical treatment:
-anti-inflammatory, antihistamines drugs, or antibiotics in the week preceding the D0 and during the study,
-immuno-suppressors and/or corticoids in the month preceding the D0 and during the study (stabilized treatment with inhaled corticosteroids for asthma and/ or nasal topical steroids for rhinitis will be allowed),
-Systemic retinoids (ex: Roaccutane®) in the six months preceding the D0 and during the study,
-any other treatment stabilized likely to interfere the results since less than one month before the D0.
· Subject who was exposed to an UV sun lamp or excessive exposure to the sun within the month prior to the study and during the study.
· Subject using dermopharmaceutical or cosmetics products (including keratolytics, salicylic acid, lactic acid, urea) other than emollients on the tested area over the period of the study.
· Subject who has a recent history (within previous 12 months) of drug addiction or alcohol abuse.
· Alcohol consumption during the study.
· Active tobacco smoker (more than 10 cigarettes/day).
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
A) Differences between UR-1505 at three concentrations (0.5%, 1% and 2%) and the active and negative controls in the IGA (Investigator global assessment) score, as assessed by clinical examination by the dermatologist of each treated lesion at day 28, according to the following score:
0 = Clear, no inflammatory signs of AD.
1 = Almost clear, just perceptible erythema and just perceptible papulation/infiltration.
2 = Mild disease, mild erythema and mild papulation/infiltration.
3 = Moderate disease, moderate erythema and moderate papulation/infiltration.
4 = Severe disease, severe erythema and sever papulation/infiltration.
5 = Very severe disesase, severe erythema and severe papulation/infiltration with oozing/crusting.
|
|
| 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 | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| 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 | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| 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
|
| End of the trial = last visit of the last subject undergoing the trial. |
|
| 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 | 3 |
| E.8.9.1 | In the Member State concerned days | |
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