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Borrelia Species in Cutaneous Lyme Borreliosis

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by University Hospital, Strasbourg, France
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: December 17, 2007
Last updated: June 8, 2016
Last verified: June 2016
The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.

Condition Intervention
Lyme Borreliosis Other: Cutaneous biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples With DNA
Cutaneous biopsy specimen

Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cutaneous biopsy
    Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans

Inclusion criteria:

  • Informed adult patient who signed written consent with one the following conditions:
  • erythema migrans
  • borrelial lymphocytoma
  • acrodermatitis chronica atrophicans

Exclusion criteria:

  • pregnancy or lactation
  • allergy to local anesthesia
  • patient who refuses biopsy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00576082

Contact: Dan LIPSKER, MD

Service de Dermatologie, Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Dan LIPSKER, MD   
Contact: Benoît JAULHAC, MD   
Principal Investigator: Dan LIPSKER, MD         
Sub-Investigator: Benoît JAULHAC, MD         
Sub-Investigator: Bernard CRIBIER, MD         
Sub-Investigator: Carine KIEFFER, MD         
Sub-Investigator: Eric FROUIN, MD         
Sub-Investigator: Pauline LEMORDANT, MD         
Sub-Investigator: Cécile PERRIGOUARD, MD         
Sub-Investigator: Jean-Nicolas SCRIVENER, MD         
Sub-Investigator: Virginie LUTZ, MD         
Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Yves HANSMANN, MD   
Sub-Investigator: Yves HANSMANN, MD         
Sub-Investigator: Guillaume CAMUSET, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Société de Dermatologie Française
Principal Investigator: Dan LISPKER, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00576082     History of Changes
Other Study ID Numbers: 3977
Study First Received: December 17, 2007
Last Updated: June 8, 2016

Keywords provided by University Hospital, Strasbourg, France:
Lyme borreliosis
Erythema migrans
Borrelial lymphocytoma
Acrodermatitis chronica atrophicans
Borrelia burgdorferi
Borrelia afzelii
Borrelia garinii

Additional relevant MeSH terms:
Borrelia Infections
Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Tick-Borne Diseases processed this record on September 19, 2017