BAP5191 study

Study participants wanted for testing the safety and tolerability of a liquid preparation on the skin of healthy individuals.

Aim of the study

It is being investigated whether the application of the preparation "BAP5191" to the skin of healthy individuals is safe and well tolerated. The aim is to develop a cure for cutaneous leishmaniasis that is safe, affordable and easy to use.

Cutaneous leishmaniasis is a neglected, tropical skin disease that affects around 600,000 to 1 million people worldwide every year. It occurs mainly in Africa, Asia, Latin America, the Middle East and the Mediterranean region. So far, the disease has received little attention in research, although it is widespread and can last for a long time.

Prerequisite for participation

  • Age: 18-65 years
  • Normal weight
  • In good health
  • Not pregnant, not breastfeeding

Two preliminary examinations, including blood tests, will be carried out to check whether you meet the requirements for participation in the study.

Procedure

38 appointments at the Outpatient Study Center of the University Hospital Basel (ASZ):

  • 2 preliminary examinations of 2 hours each
  • 32 daily visits on consecutive days (2 of them with overnight stay in the ASZ, all other visits last approx. 2h)
  • 4 follow-up visits of 1h each (once a week, for 4 consecutive weeks)
  • BAP5191 and a placebo are applied to the back for 28 days (including weekends and public holidays). The application takes place in the ASZ.

Duration: approx. 3 months

Allowance for expenses

Up to CHF 3130. Travel expenses on presentation of proof.

Benefit

You will not derive any medical benefit from participating in the study. However, your participation may help future patients with cutaneous leishmaniasis.

Study management

Prof. Dr. med. Alexander Navarini Chief Physician Dermatology University Hospital Basel

contact

If you are interested or have any questions, please send an e-mail with your name and telephone number to BAP5191@usb.ch with the subject "BAP5191-101". You will then be contacted by e-mail or telephone.

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