Study on Adhesion Properties of Three Different Adhesives

NCT04125797 | Completed

• 1 other identifier: CIS-015
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Skin adhesion rating

  Rate of adhesion on a 5-point scale (no lift off the skin to deattached and completely off the skin)

  Minimum 72 hours after application

Secondary Outcomes (5)

• Itch

  24, 48 and 72 hours after adsive application

• Ease of removal

  Minimum 72 hours after application

• Pain during removal of adhesive

  Minimum 72 hours after application

• Rate of skin reaction

  Minimum 72 hours after application

• Adhesive residue

  Minimum 72 hours after application

Study Arms (3)

Adhesive 1

ACTIVE COMPARATOR

This arm investigates one type of silicone adhesive (3M2475P) on adult female skin.

Other: Application of adhesive

Adhesive 2

ACTIVE COMPARATOR

This arm investigates one type of silicone adhesive (RX1449P) on adult female skin.

Other: Application of adhesive

Adhesive 3

ACTIVE COMPARATOR

This arm investigates one type of silicone adhesive (PS-1243) on adult female skin.

Other: Application of adhesive

Interventions

Application of adhesive OTHER

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

Adhesive 1; Adhesive 2; Adhesive 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ambu A/S: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 14, 2019
• Study Start: October 7, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)