Healthy
Conditions
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.
Interventions
OTHERApplication of adhesive
Adhesive will be placed on the subjects skin on the trunk. Placement of the adhesive will be randomized.
Sponsors
Ambu A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The one arm tested three adhesives in parallel in random positions on the trunk. Investigator and participants were however blinded to the randomization placement.
Intervention model description
Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk. The position of the three adhesives on each side are randomly allocated.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Adhesion Success After 72 Hours | After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor | Did the adhesive stay attached to the skin for 72 hours (Yes/No). For the adhesive to be considered attached (yes) more than 75% adherence should be achieved. Rate of adhesion on a 5-point scale (no lift off the skin to detached and completely off the skin) 0 = ≥90% adhered (essentially no lift off the skin). 1. = ≥75% to \<90% adhered (only some edges lift off the skin). 2. = ≥50% to \<75% adhered (less than half lifts off the skin). 3. = \>0% to \< 50% adhered (more than half lifts off the skin without falling off). 4. = 0% adhered (detached and is completely off the skin). A worst-case scenario was used, i.e. the least favourable, score of the two scores (there are two scores as there are two adhesives of each type on every subject) for each type of adhesive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours | 24, 48 and 72 hours after adhesive application | Subject evaluation of itchiness caused by the adhesives at 24, 48, 72 hours measured on visual analogue scale (VAS) (0-10) 0 = 'No itch', 10 = Worst imaginable itch. Adhesives when only including the worst score on each adhesive for each subject |
| Rate of Ease of Removal of Adhesive After 72 Hours | After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor | Ease of removal on 5-point scale (very difficult to very easy) ; 1: Very difficult; 2: Difficult; 3: Acceptable; 4: Easy; 5: Very easy. |
| Rate of Pain During Removal of Adhesive After 72 Hours | After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor | Subject evaluation of pain during removal of the adhesives measured on visual analogue scale (0-10). 0= no pain, 10 = Worst possible pain |
| Rate of Skin Reaction After Wearing Adhesive for 72 Hours | After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor | Skin reaction rated on a scale from 0-7 (no evidence of irritation to strong reaction spreading beyond the application site). 0: No evidence of irritation 1. Minimal erythema that is barely perceptible 2. Definite erythema that is readily visible and minimal edema or minimal papular response 3. Erythema and papules 4. Definite edema 5. Erythema, edema and papules 6. Vesicular eruption 7. Strong reaction spreading beyond the application site |
| Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive | After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor | The number of participants with any adhesive residue left on skin after removal of adhesive (yes/no) after 72 hours. |
Countries
Denmark
Participant flow
Pre-assignment details
This clinical investigation was a single centre, double blinded, case control study in healthy adult females. The investigation centre enrolled 39 subjects within one month. The three (3) types adhesive were randomly placed on subject's trunk. Each study participant will test two patches of each of three different experimental adhesives. Six patches in total. One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 24.16 Years STANDARD_DEVIATION 2.9 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
None listed