HealthyNCT04125797
Study on Adhesion Properties of Three Different Adhesives
A study testing Application of adhesive in people with Healthy, run by Ambu A/S at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Application of adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Oct 2019to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Application of adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of adhesiveOther
Adhesive will be placed on the subjects skin on the trunk. Placement of the adhesive will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | 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. Receives: Other: Application of adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Adhesion Success After 72 Hours
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).
- = ≥75% to <90% adhered (only some edges lift off the skin).
- = ≥50% to <75% adhered (less than half lifts off the skin).
- = >0% to < 50% adhered (more than half lifts off the skin without falling off).
- = 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.
Measured: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Secondary outcomes (5)
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
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
Measured: 24, 48 and 72 hours after adhesive application
Rate of Ease of Removal of Adhesive After 72 Hours
Ease of removal on 5-point scale (very difficult to very easy) ; 1: Very difficult; 2: Difficult; 3: Acceptable; 4: Easy; 5: Very easy.
Measured: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Rate of Pain During Removal of Adhesive After 72 Hours
Subject evaluation of pain during removal of the adhesives measured on visual analogue scale (0-10). 0= no pain, 10 = Worst possible pain
Measured: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Rate of Skin Reaction After Wearing Adhesive for 72 Hours
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
- Minimal erythema that is barely perceptible
- Definite erythema that is readily visible and minimal edema or minimal papular response
- Erythema and papules
- Definite edema
- Erythema, edema and papules
- Vesicular eruption
- Strong reaction spreading beyond the application site
Measured: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
The number of participants with any adhesive residue left on skin after removal of adhesive (yes/no) after 72 hours.
Measured: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start7 Oct 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125797
- Sponsor's protocol ID
- CIS-015
- Status last verified
- May 2026
- First submitted
- 11 Oct 2019
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers
- ClinicalTrials.gov ID
- NCT04125797
- Acronym / sponsor ID
- CIS-015
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Other: Application of adhesiveEach 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of adhesiveAdhesive will be placed on the subjects skin on the trunk. Placement of the adhesive will be randomized. | Other | All study participants |
Primary outcome
Number of Participants Who Achieved Adhesion Success After 72 Hours
Time frame: 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.
5 secondary outcomes
Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
Time frame: 24, 48 and 72 hours after adhesive application
Rate of Ease of Removal of Adhesive After 72 Hours
Time frame: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Rate of Pain During Removal of Adhesive After 72 Hours
Time frame: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Rate of Skin Reaction After Wearing Adhesive for 72 Hours
Time frame: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
Time frame: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of adhesive in people with Healthy, run by Ambu A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved Adhesion Success After 72 Hours (time frame: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.