AntibioTx has developed a topical product (ATx201) for treatment of infected eczema and infected atopic dermatitis. These infections are predominantly caused by Staphyllococcus aureus and various species of Streptococcus. Treatment of these infections is plagued by inactivity of or resistance towards the main topical antibiotics (fucidic acid, mupirocin and retapamulin). MedDRA version: 20.0 Level: HLT Classification code 10040788 Term: Skin and subcutaneous tissue bacterial infections System O
Conditions
Interventions
Product Name: ATx201
Pharmaceutical Form: Gel
INN or Proposed INN: Niclosamide, anhydrous
CAS Number: 50-65-7
Current Sponsor code: ATx201
Other descriptive name: NICLOSAMIDE
Concentration unit: % per
Sponsors
AntibioTx ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria: - Signed and dated informed consent has been obtained - Age 18 – 70 years - Male or female - Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment - Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion - Male subjects must agree to use adequate contraception for the duration of the trial Additional inclusion criteria for Phase II of the study: - Localized disease where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigator global assessment (IGA) score between 1-4 and is colonized by S. aureus with at least 1,000 cfu/cm2. - Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment (IGA) score between 1-4. 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 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: General exclusion criteria - Clinically relevant abnormalities in the laboratory testing, vital signs, ECG (Phase I only) or physical examination unless considered clinically irrelevant for the scope of the trial by the Investigator - Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication - History of irritation to topical products - Current acute or chronic disease unless considered clinically irrelevant for the scope of the trial by the Investigator - Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study - Positive HIV serology or evidence of active hepatitis - Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference) - History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005) - Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal - Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits) - Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating - Participation in another clinical trial with an investigational drug within 4 weeks before Screening Additional exclusion criteria for Phase I of the study: - Regular use of medications unless considered clinically irrelevant by the Investigator - Use of any dermatological drug therapy on the arms within 14 days before day 1 of this study Additional exclusion criteria for Phase II of the study: - Treatment with antibiotics (systemic or topical) within the past 2 months taken for systemic application, and four weeks use of topical antibiotics prior entering the study, and use of those during the study - Treatment with cyclosporins within the last four weeks, use of methotrexate or mycophenolate mofetil within the last eight weeks, and biologicals within 5 times the biological half life prior to entering the study. - Treatment with topical (dermatological) steroids and calcineurin inhibitors 1 week prior to start of treatment and during the study - Treatment with systemic steroids within the past month and during the study - Use of disinfectant soaps within 1 week before screening and during the study treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the safety and tolerability of new topical formulations of ATx201 in healthy volunteers, and in a population of patients with atopic dermatitis and to assess efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment. Therefore, in Phase I of the study, three formulations of ATx201 including the respective Placebos will be applied to healthy volunteers. One formulation will advance into Phase II, where patients will be treated with the respective formulation or Placebo.;Secondary Objective: Phase I: - To determine the local and systemic exposure of ATx201 - Exploratory Objective: To collect illustrative information on local tolerability of ATx201 To determine the best tolerable formulation to advance into Phase II. Phase II: - To assess the impact of ATx201 on the treated atopic dermatitis lesion - To determine the systemic exposure of ATx201 - Exploratory Objectives: To assess the impact of ATx201 and formulation on pruritus (using a VAS scale) To collect illustrative information on efficacy of ATx201 To assess the EASI score per single lesion;Primary end point(s): Primary efficacy endpoint is the treatment success, defined as a 100-fold reduction in the S. aureus colony count/cm2 of sampled skin lesion after 4 and 7 days treatment ;Timepoint(s) of evaluation of this end point: After 4 and 7 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoint is the relative decrease of S. aureus colonies/cm2 on treated skin after 4 and 7 days treatment of the active groups, relative to their Placebos as well as relative to the non treated area. All safety endpoints (including physical exam, vital signs, ECG (phase I only), safety laboratory) Number and type of (serious) adverse events Local tolerability assessment scores compared to Placebo;Timepoint(s) of evaluation of this end point: Efficacy: After 4 and 7 days of treatment Safety: Screening until End of study | — |
Countries
Austria
Contacts
Public ContactAntibioTx ApS
AntibioTx ApS
Outcome results
None listed