Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.

Detailed Description

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In this study two consecutive cohorts will be treated:

* Cohort 1: 8 volunteers
* Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each

The study will be conducted in the following three phases:

1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.

1. Treatment of cohort 1 with azithromycin dermal formulation and follow up
2. Assessment of local safety within the 7 days following the first treatment
3. The maximal tolerated dose (MTD) will be determined
2. Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.

1. Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (MTD), with a dose one or more concentrations lower than maximal tolerated dose (MTD) and with placebo
2. Skin biopsies of treated skin areas will be taken for the PK assessment
3. Study completion examination

Conditions

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Lyme Disease

Keywords

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Lyme disease Borreliosis Azithromycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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Application of SHB001

* Cohort 1: Application of SHB001 on the skin of right thigh
* Cohort 2:

1. Application of SHB001 on the skin of right thigh
2. punch biopsies of treated skin areas

Intervention Type DRUG

Other Intervention Names

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0% SHB001 azitrhomycin dermal formulation (placebo) 5% SHB001 azitrhomycin dermal formulation 10% SHB001 azitrhomycin dermal formulation

Eligibility Criteria

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Inclusion Criteria

* Male or female healthy volunteers, age 18 - 70 years

Exclusion Criteria

* A known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics
* A known hypersensitivity against lidocaine
* Treatment by any route with any macrolide antibiotic within the last 2 month

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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University Hospital Zurich

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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Clinical Trials Center, University and University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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IXO-01

Identifier Type: -

Identifier Source: org_study_id