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Completed

NCT Number: NCT04125797

Study on Adhesion Properties of Three Different Adhesives

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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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application of adhesive

Other

Adhesive will be placed on the subjects skin on the trunk. Placement of the adhesive will be randomized.

Primary outcomes

  1. 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).

    • = ≥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.

Secondary outcomes

  1. Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours

    Time frame: 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

  2. 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

    Ease of removal on 5-point scale (very difficult to very easy) ; 1: Very difficult; 2: Difficult; 3: Acceptable; 4: Easy; 5: Very easy.

  3. 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

    Subject evaluation of pain during removal of the adhesives measured on visual analogue scale (0-10). 0= no pain, 10 = Worst possible pain

  4. 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

    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

  5. 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

    The number of participants with any adhesive residue left on skin after removal of adhesive (yes/no) after 72 hours.

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Registry information

Official study title

A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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