Subjects with mild to moderate atopic eczema MedDRA version: 14.0 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Tarenflurbil Spray 4 %
Pharmaceutical Form: Cutaneous spray
INN or Proposed INN: Tarenflurbil
CAS Number: 51543-40-9
Current Sponsor code: Tarenflurbil Spray 4%
Concentration unit: % per
Sponsors
GALENpharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male or female subjects, 18 years or older; • manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3); • two comparable lesional areas of 30 - 40 cm2 with a distance of at least 5 cm (difference in modified local SCORAD not greater than 2), clinical condition of atopic eczema mild to moderate; clinical condition of atopic eczema mild to moderate defined by a modified local SCORAD of at least 4 with ? erythema = 1 ? lichenification = 1 ? dryness = 1 • TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas (related to the higher TEWL value); • the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial; female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) 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, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • written informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • acne, suntan, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas; • dark-skinned persons whose skin color prevents ready assessment of skin reactions; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within 6 weeks before first treatment; • symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial; • participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial; • known allergic reactions to components of the investigational product/s; • treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed); • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; • close affiliation with the investigator (e.g. a close relative) or persons working at the study sites or subject is an employee of sponsor; • subject is institutionalized because of legal or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate efficacy of Tarenflurbil Spray 4 % on lesional skin by clinical assessment of skin condition in subjects with mild to moderate atopic eczema. ;Secondary Objective: The secondary objective is to assess the effect of Tarenflurbil Spray 4 % on barrier impairment by measurement of transepidermal water loss (TEWL) in subjects with mild to moderate atopic eczema.;Primary end point(s): Comparison of active IMP vs. vehicle with respect to the change from baseline in modified local SCORAD on day 29;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of active IMP vs vehicle with respect to the change from baseline in modified local SCORAD on days 8 and 15 Modified local SCORAD on days 1, 8, 15, and 29 Change from baseline in TEWL on days 8, 15, and 29 TEWL on days 1, 8, 15, and 29 ;Timepoint(s) of evaluation of this end point: Days 1, 8, 15, and 29 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information Desk
bioskin GmbH
Outcome results
None listed