A single center randomised placebo controlled study to test a novel topical formulation containing Niclosamide, an antibiotic.

Phase 1

• Conditions: 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: 20.0Level: HLTClassification code 10040788Term: Skin and subcutaneous tissue bacterial infectionsSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003501-33-AT
• Lead Sponsor: AntibioTx ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-07
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 76

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified