Avexxin (AVX001) 3% Ointment (NG) in Atopic Dermatitis – safety and efficacy study

Phase 1

Conditions: MedDRA version: 19.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-003013-96-DK

Lead Sponsor: Avexxin AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.