Clinical trial NCT04125797: Study on Adhesion Properties of Three Different Adhesives
Official title: A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Female Healthy Volunteers.
* Age 18 - 40 years old.
* Willing to attend two scheduled visits
* Able to assess itch and adherence at 24h, 48h and 72h.
* Provide written informed consent.

Exclusion Criteria:

* Non-intact skin barrier (e.g. eczema, rash, cut, scar tissue, wound, etc.).
* History of inflammatory skin diseases (e.g. atopic dermatitis or psoriasis).
* History of contact allergy
* Swimming or engaging in sport activities causing sweat during study peri-od. v. Use of medication (e.g. corticosteroids) which could affect skin reactions.

Primary outcomes:
measure: Skin adhesion rating
timeFrame: Minimum 72 hours after application
Secondary outcomes:
measure: Itch
timeFrame: 24, 48 and 72 hours after adsive application
measure: Ease of removal
timeFrame: Minimum 72 hours after application
measure: Pain during removal of adhesive
timeFrame: Minimum 72 hours after application
measure: Rate of skin reaction
timeFrame: Minimum 72 hours after application
measure: Adhesive residue
timeFrame: Minimum 72 hours after application
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References: