Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

A Single Centre, Randomized, Investigator Blinded, Placebo-controlled Ascending Dose Study to Assess the Local Safety, the Skin and Plasma Concentration of Azithromycin Dermal Formulation During Repeated Applications on the Skin of Healthy Volunteers

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243008

Acronym

IXO-01

Enrollment

Registered

2010-11-17

Start date

2010-04-30

Completion date

2010-11-30

Last updated

2010-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Disease

Keywords

Lyme disease, Borreliosis, Azithromycin

Brief summary

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

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

Interventions

DRUGApplication 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Main inclusion criteria: * Male or female healthy volunteers, age 18 - 70 years Main

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

Design outcomes

Primary

Measure	Time frame	Description
Local safety	April 2010 - November 2010	The primary objective of this study is to assess the local safety of azithromycin dermal formulation when applied to healthy skin in healthy volunteers. This will be done by determination (in cohort 1) and confirmation (in cohort 2) of the maximal tolerated dose (MTD) after dermal application of SHB001 in 4 different dose regimens.

Secondary

Measure	Time frame	Description
Pharmacokinetics of SHB001	April 2010 - November 2010	* To assess the pharmacokinetics of azithromycin dermal formulation in the plasma in healthy volunteers after daily administration for three consecutive days in cohort 1 and cohort 2. * To assess the pharmacokinetics of azithromycin dermal formulation in the skin in healthy volunteers after daily administration for 1 - 3 consecutive days in cohort 2 only. * To demonstrate that the Minimal Inhibitory Concentration (MIC) of B.b. (=0.03μg/ml) in the skin is reached at least for 2 consecutive assessments (biopsies) in cohort 2. * To assess general safety in cohort 1 and 2.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026