Study on Adhesion Properties of Three Different Adhesives

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125797
• Other study ID #: CIS-015
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Ambu A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Other:
• Application of adhesive
Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Ambu A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Itch	Subject evaluation of itch during removal measured on visual analogue scale (0-10)	24, 48 and 72 hours after adsive application
Secondary	Ease of removal	Ease of removal on 5-point scale (very difficult to very easy)	Minimum 72 hours after application
Secondary	Pain during removal of adhesive	Subject evaluation of pain during removal measured on visual analogue scale (0-10)	Minimum 72 hours after application
Secondary	Rate of skin reaction	Skin reaction rated on a scale from 0-7 (no evidence of irritation to strong reaction spreading beyond the application site)	Minimum 72 hours after application
Secondary	Adhesive residue	Adhesioe residue left on skin after removal of adhesive (yes/no)	Minimum 72 hours after application