MedDRA version: 19.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: AVX001 ointment
Product Code: AVX001
Pharmaceutical Form: Ointment
Current Sponsor code: AVX001
Other descriptive name: AVX001
Concentration unit: % percent
Concentration type: equal
Con
Sponsors
Avexxin AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures 2. Caucasian male and female Subjects aged 16 years or more with Atopic Dermatitis according to the Hanifin-Rajka criteria and with any degree of severity of disease. 3. Atopic Dermatitis affecting symmetrical anatomic sites with disease severity mild, moderate and severe AD based on measurement of standard SCORAD 4. Target lesions (TL) with active dermatitis shall be more than 3 cm in diameter and present at least two of the signs erythema, infiltration and scaliness, in each test site. Symmetrical Target Area’s (TAs) defined as approximately the size of a palm when distributing ointment equivalent to a full fingertip, shall according to Investigator’s spontaneous clinical judgement be comparable in disease activity. 5. Physical examination of the skin must be without abnormal findings other than AD unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial. Are the trial subjects under 18? yes Number of subjects for this age range: 4 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Any condition in the TAs that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than Atopic Dermatitis, hyper- or hypopigmentation, scars. 2. Any permanent or transient within a 4 weeks period prior to dosing that may interfere with the subjects’ safety or ability to participate in the trial and any condition that according to Investigator’s evaluation may confound or invalidate with clinical assessments and recordings. 3. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, condom with spermicide, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner. Contraception must be maintained from the time of first dosing until 3 months after dosing 4. Topical treatment of the selected target lesions with topical steroids, topical calcineurin inhibitors (e.g. pimecrolimus, tacrolimus), anti-bacterials or antihistamines 2 weeks prior to dosing 5. Systemic long term treatments such as azathioprine are allowed provided the dose of such drug is not changed during the study. If changed the investigator shall decide if the change is small and unlikely to influence the study outcome or, alternatively, of a magnitude, which is likely to be of clinically significant influence to target areas. 6. Phototherapy (e.g. PUVA or UVB) within 4 weeks prior to dosing or during the study treatment phase and extensive sun exposure (e.g. sunbathing, solarium) during the study and 1 week prior to baseline evaluation. 7. Use of emollients on the TLs within 3 days prior to dosing and during the study treatment phase (note: emollients may be used during the study outside the TLs). 8. Known or suspected hypersensitivity to component(s) of the investigational product(s). 9. Subjects known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency, psychological disorder or other conditions) 10. Females who are pregnant or trying to fall pregnant during the study as well as female that are breast feeding 11. Participation in another clinical trial within 4 weeks prior to randomization 12. Subjects previously randomised and dosed in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate local cutaneous tolerability of AVX001 3% Ointment (NG) compared to placebo, when topically applied. The two lesions are selected as sites of clinically comparable active dermatitis in two symmetrical anatomical sites in subjects with a definite diagnosis of Atopic Dermatitis according to the Hanifin-Rajka criteria and with any degree of severity of disease, studied in a fourweek period with a two week follow up.;Secondary Objective: 1. Evaluation of safety profile by recording of adverse events (AEs), clinical laboratory data, and vital signs 2. Investigators overall clinical assessment of changes in AD 3. To evaluate therapeutic efficacy based on clinical assessment and objective measures of skin thickness and skin color 4. To evaluate subject comfort and satisfaction with the ointment 5. To assess pruritus according to subjects evaluation 6. To assess a possible appearance of the study drug in plasma;Primary end point(s): Number of subjects experiencing local skin reaction and any other local adverse event at the treated sites (LSRAE) during treatment and follow-up period.;Timepoint(s) of evaluation of this end point: End of follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of treatment or end of follow up;Secondary end point(s): 1. Assessment of systemic safety based on reported SAE, AE, Laboratory data, vital signs and physical examination 2. Physician’s Global Assessment of Target Lesion (PGATL) grade 0 to grade 5 3. Change in the modified SCORAD (SCORing Atopic Dermatitis) clinical score for assessment of severity of dermatitis, in this case adapted to scoring of target lesions. Changes in thickness of the skin lesion based on 20 MHz ultrasound measurement of skin thickening due to inflammatory oedema. Changes in color due to inflammatory vasodilatation based on colorimetri 4. Subject satisfaction with the ointment (NG) (i.e. Pleasant to use, Spreadability, Greasiness, Stinging/smarting) will be studied using a questionnaire 5. Subject’s Reported atopic dermatitis-related pruritus using a visual analog scale (VAS ) 6. Plasma concentration above Lower Limit of Quantification (LLOQ) of study drug at the last day of treatment | — |
Countries
Denmark
Contacts
Public ContactPeter Damsbo
AVEXXIN AS
Outcome results
None listed