ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation (IXO-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01243008
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 19, 2010
Sponsor:
Collaborators:
Ixodes GmbH
Appletree AG
Information provided by:
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Lyme Disease Drug: Application of SHB001 Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease


Intervention Details:
  • Drug: 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
    Other Names:
    • 0% SHB001 azitrhomycin dermal formulation (placebo)
    • 5% SHB001 azitrhomycin dermal formulation
    • 10% SHB001 azitrhomycin dermal formulation


Primary Outcome Measures :
  1. Local safety [ Time Frame: 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 Outcome Measures :
  1. Pharmacokinetics of SHB001 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243008


Locations
Switzerland
Clinical Trials Center, University and University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Ixodes GmbH
Appletree AG
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Responsible Party: Thomas Kündig, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT01243008     History of Changes
Other Study ID Numbers: IXO-01
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by University of Zurich:
Lyme disease
Borreliosis
Azithromycin

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections