Evaluation of ATx201 as a Topical Antibiotic Agent

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03009734
• Date of registration: 22/12/2016
• Prospective Registration: No
• Primary sponsor: UNION therapeutics
• Public title: Evaluation of ATx201 as a Topical Antibiotic Agent
• Scientific title: A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent
• Date of first enrolment: December 2016
• Target sample size: 73
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03009734
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Austria

Contacts

• Name: Markus Zeitlinger, MD
• Affiliation: General Hospital Vienna

Key inclusion & exclusion 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 (e.g. flexural eczema in a more or less symmetrical distribution on
arms) where two individual lesions each covering an area between 10-200 cm2 and where
each individual lesion has an investigators global assessment score between 1-3.

- Additional localized lesion of area between 10-200 cm2 and where the individual lesion
has an investigators global assessment score between 1-3.

- Total localized disease not exceeding 20 % body surface area

- Colonization of lesions with S.aureus as determined by cultivation

General exclusion criteria

- Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase
I only) or physical examination

- 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 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)

- caffeine (>5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more
cigarettes/week)

- abnormal or special diet (e.g. vegetarian diet)

- 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 day within 4 weeks
before screening

Additional exclusion criteria for Phase I of the study:

- Regular use of medications

- 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 3 months and during
the study

- Treatment with drugs that affect the immune system within the past 3 months and during
the study

- Treatment with topical steroids and calcineurin inhibitors 1 week before and during
the study treatment period

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Infection, Bacterial

Intervention(s)

Drug: ATx201 dermal formulations 2%

Primary Outcome(s)

Safety and tolerability of new topical formulations of ATx201 [Time Frame: 7 days]

Secondary Outcome(s)

Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201. [Time Frame: 4 and 7 days]

Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion [Time Frame: 4 and 7 days]

Safety and tolerability of new topical formulations of ATx201 [Time Frame: 4 and 15 days]

Local dermal tolerability at the sites of application [Time Frame: 7 days]

Secondary ID(s)

DECOLAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors