The clinical study LF-01-01 is the result of another collaboration of Blueclinical with a Portuguese start-up: Labfit - Health Products Research and Development, Lda (Labfit). Labfit is a spin-off of University of Beira Interior and has developed a medical device for symptom relief of chronic non-hypertrophic vulvar dermatosis.
Currently there is a set of chronic diseases of the vulva with no known cause and whose treatment is unsatisfactory. Treatment of these conditions is often done using drugs that decrease the immune response, like corticosteroids. LabiaStick is a natural base product containing natural beeswax, Helichrysum italicum essential oil and a few (stabilizing) substances, and has been developed to allow a smooth and comfortable application to the vulva, similar to the use of Lipstick.
Blueclinical has been supporting Labfit in this project since 2013, being involved in several phases of the process, from supporting the request for funding to designing and implementing the clinical trial. In particular, Blueclinical has provided support for the following activities: regulatory advice, medical writing, statistics, project management, data management, selection and opening of test centers, conducting the study and monitoring.
The LF-01-01 is a clinical study with intervention of a medical device, currently implemented in 3 national test centers: Hospital Center of Cova da Beira E.P.E; Hospital Center of São João E.P.E; Apomédica - Serviços médica Lda, and is expected to open three more national centers soon.
For more information about the LF-01-01 please visit: