Healthy Volunteer StudyNCT07034014
An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices
A study testing Dressing in people with Healthy Volunteer Study, run by Molnlycke Health Care AB at 1 site in Germany.
Trial summary
This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are capable and willing to comply with protocol visits, assessments, and instructions.
- Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).
- Minimal hairiness at the back (location of the application sites).
- Signed written informed consent.
Who cannot join
- Known allergy/hypersensitivity to the dressing or its components.
- Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.
- Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid the use of leave on cosmetics such as creams/lotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.
- Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.
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- Participants whose back is not large enough to accommodate all 12 application sites
- Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
- Active skin disease at the application sites .
- Any topical medication at the application sites within the last 24 hours prior to the start of the test and/or throughout the entire course of the investigation.
- Pain relief medication on assessment visits . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as protocol deviation.
- Pregnancy or lactation.
- Drug addicts, alcoholics.
- AIDS, HIV-positive or infectious hepatitis.
- Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).
- Participation in another investigative drug or device study currently or within the last 30 days.
- Current participation in a cosmetic study.
- Employees of the investigation sites directly involved in this clinical investigation.
- Employees of the sponsor's company.
- Employees of a competitor company. The participant should not work for any company which produces dressings.
- The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
SGS proderm GmbH
Schenefeld, Free and Hanseatic City of Hamburg, 22869
Uta Solecke, Dr., +49 40 839 358 160, USolecke@proderm.de
About this study
Official title: A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices
This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
- Conditions
- Healthy Volunteer Study
- Being tested
- Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DressingDevice
The dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back.
| Study group | Role | What they receive |
|---|---|---|
| 12 dressings applied to designated sites on healthy volunteer participants | Other | The investigation will evaluate the dressing and the application regimen. Receives: Device: Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate stay-on-ability of the test specimens compared to the test specimen reference
The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14.
Unit of Measure: Percentage (%)
Measured: From enrollment to end of follow-up at day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start5 Jun 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Uta Solecke, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034014
- Sponsor's protocol ID
- PENGUIN study
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices
- ClinicalTrials.gov ID
- NCT07034014
- Acronym / sponsor ID
- PENGUIN study
- Conditions
- Healthy Volunteer Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
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 will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12 dressings applied to designated sites on healthy volunteer participants | Other | Device: DressingThe investigation will evaluate the dressing and the application regimen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are capable and willing to comply with protocol visits, assessments, and instructions.
- Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).
- Minimal hairiness at the back (location of the application sites).
- Signed written informed consent.
Key exclusion criteria (22 listed)
- Known allergy/hypersensitivity to the dressing or its components.
- Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.
- Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid the use of leave on cosmetics such as creams/lotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.
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 |
|---|---|---|
| DressingThe dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back. | Device | 12 dressings applied to designated sites on healthy volunteer participants |
Primary outcome
Evaluate stay-on-ability of the test specimens compared to the test specimen reference
Time frame: From enrollment to end of follow-up at day 14.
The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14. Unit of Measure: Percentage (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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.
Dr. Uta Solecke principal investigator
SGS Proderm GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing in people with Healthy Volunteer Study, run by Molnlycke Health Care AB at 1 site in Germany.
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 4 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Welinder (+46 (0)31- 722 31 96, kristina.welinder@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate stay-on-ability of the test specimens compared to the test specimen reference (time frame: From enrollment to end of follow-up at day 14.). 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 24 Jun 2025.