Healthy Clinical Trial
Official title:
A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers
This clinical investigation is a single centre, double blinded, case control study in healthy
adult females. This study will be conducted in private rooms at Gentofte Hospital
(Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).
The investigation centre will enroll 39 subjects including a 20% drop out within a four (4)
months period. The subject will not be enrolled before approval of investigation protocol by
the local ethics committee.
The subjects need to meet the inclusion and exclusion criteria to be included in this
clinical investigation. Each volunteer enrolled in the investigation can only participate
once in a procedure. The testing period for each subject will be minimum 72 hours.
The principal investigator's qualifications will be verified through his/her CV. The
principal investigator is required to be a medical doctor with at least one year's experience
in using similar medical adhesives (e.g. by being experienced in using electrodes where
medical adhesives are included) and at least one year's experience with clinical research. In
addition, the investigator must be trained in GCP before the study is initiated.
If any subject withdraws from the study, they will not be replaced as drop-out rate is
included in the sample size.
Subjects must show up for two sessions, in the first session six adhesives will be placed
below the subjects bra. The adhesives will be removed after minimum 72 hours at the second
visit. While wearing the adhesives the subjects must keep the investigational area dry. 24,
48 and 72 hours after placement of the adhesives, the subject is asked to completed a
questionnaire.
The eCRF must be completed for each subject that has signed the Informed consent form (ICF)
and enrolled into this clinical investigation.
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