HealthySPECIMENNCT07117747
Non-invasive Sampling Method for Skin Test: Optimization of Sample Collection and Extraction
A study testing Healthy volunteers in people with Healthy, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
When absorbent hygiene products-such as panty liners, sanitary pads, incontinence products, or wound care items-are used over extended periods, they can sometimes have negative effects on the skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Healthy volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2025to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: men/women
- Age: >18 years
- Subjects with full legal competence
- Subjects who have provided a signed informed consent and willing to come to the scheduled visit at the test site
Who cannot join
- Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
- Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
- Subjects with known sensitivity or allergy to adhesives and nylon
- Have immunodeficiency, taking any anti-inflammatory medication or having any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator
- Subjects with hairy forearms
- Subjects with active skin diseases on the forearms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Skin Sampling: Optimization of Sample Collection and Extraction. Enhancing Cytokine Recovery by the Modification of Extraction Solvents and the Use of Alternative Sampling Methods
When absorbent hygiene products-such as panty liners, sanitary pads, incontinence products, or wound care items-are used over extended periods, they can sometimes have negative effects on the skin. The aim of the current study is to investigate the best way to measure the amount of cytokines on the skin through a non-invasive method.
Cytokines are small proteins that act as signaling molecules in the immune system and regulate inflammation and the body's response to infections. Because inflammatory markers often appear in very low concentrations in skin surface samples, it is essential to optimize both collection and extraction methods to overcome this limitation.
The researchers want to evaluate different sampling and extraction techniques to measure the skin's inflammatory response. The effectiveness assessment involves determining how well these methods can detect and analyze inflammatory markers. This includes ensuring the sampling methods are non-invasive yet sensitive enough to detect subtle changes in skin inflammation. Furthermore, the extraction methods must efficiently isolate relevant biomarkers to provide reliable data on the skin's response to the products.
Read the detailed description
The aim of this project was to refine a non-invasive skin sampling technique, enhancing cytokine recovery by optimizing both the sample collection method (tape stripping or swabbing) and the cytokine extraction solvent (including buffer type, detergent, and detergent concentration). The analytes of interest were the following five cytokines: IL-1α, IL-1RA, IL-6, IL-8, and TNF-α, which are signaling molecules in the immune system and important inflammatory biomarkers. ELISA was used for quantitative analysis.
Tape stripping and swabbing are two non-invasive skin sampling methods. For tape stripping, sample collection and extraction have been performed using D-Squame tape and an extraction buffer reported in relevant publications. Expanding the list of detectable cytokines allows for more accurate evaluations of skin condition.
- Conditions
- Healthy
- Being tested
- Healthy volunteers
- Keywords
- Absorbing hygiene product, Skin sampling, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy volunteersOther
All subject belong to the same arm and ther is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Single arm study Receives: Other: Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine detection
the detection of cytokines obtained by the different extraction solvents and sampling methods. ELISA complemented with the Micro BCA Protein Assay were used to quantify the cytokine recovery (in pg/ug total soluble protein).
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Mar 2025
- Primary completion29 Apr 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Samples are taken from the forearms of healthy individuals at two visits and the amount of cytokines that can be retrieved from the samples re extracted using various methods in order to optimize the protocol.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warangkana Lohcharoenkal, PhD, Principal investigator, Essity Hygiene and Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117747
- Sponsor's protocol ID
- C3351
- Acronym
- SPECIMEN
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Skin Sampling: Optimization of Sample Collection and Extraction. Enhancing Cytokine Recovery by the Modification of Extraction Solvents and the Use of Alternative Sampling Methods
- ClinicalTrials.gov ID
- NCT07117747
- Acronym / sponsor ID
- SPECIMEN / C3351
- Conditions
- Healthy
- Keywords
- Absorbing hygiene product, Skin sampling, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 12 Aug 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.
When absorbent hygiene products-such as panty liners, sanitary pads, incontinence products, or wound care items-are used over extended periods, they can sometimes have negative effects on the skin. The aim of the current study is to investigate the best way to measure the amount of cytokines on the skin through a non-invasive method.
Cytokines are small proteins that act as signaling molecules in the immune system and regulate inflammation and the body's response to infections. Because inflammatory markers often appear in very low concentrations in skin surface samples, it is essential to optimize both collection and extraction methods to overcome this limitation.
The researchers want to evaluate different sampling and extraction techniques to measure the skin's inflammatory response. The effectiveness assessment involves determining how well these methods can detect and analyze inflammatory markers. This includes ensuring the sampling methods are non-invasive yet sensitive enough to detect subtle changes in skin inflammation. Furthermore, the extraction methods must efficiently isolate relevant biomarkers to provide reliable data on the skin's response to the products.
Detailed description
The aim of this project was to refine a non-invasive skin sampling technique, enhancing cytokine recovery by optimizing both the sample collection method (tape stripping or swabbing) and the cytokine extraction solvent (including buffer type, detergent, and detergent concentration). The analytes of interest were the following five cytokines: IL-1α, IL-1RA, IL-6, IL-8, and TNF-α, which are signaling molecules in the immune system and important inflammatory biomarkers. ELISA was used for quantitative analysis.
Tape stripping and swabbing are two non-invasive skin sampling methods. For tape stripping, sample collection and extraction have been performed using D-Squame tape and an extraction buffer reported in relevant publications. Expanding the list of detectable cytokines allows for more accurate evaluations of skin condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Samples are taken from the forearms of healthy individuals at two visits and the amount of cytokines that can be retrieved from the samples re extracted using various methods in order to optimize the protocol.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Healthy volunteersSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sex: men/women
- Age: >18 years
- Subjects with full legal competence
- Subjects who have provided a signed informed consent and willing to come to the scheduled visit at the test site
Key exclusion criteria (6 listed)
- Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
- Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
- Subjects with known sensitivity or allergy to adhesives and nylon
- Have immunodeficiency, taking any anti-inflammatory medication or having any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator
- Subjects with hairy forearms
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 |
|---|---|---|
| Healthy volunteersAll subject belong to the same arm and ther is no intervention | Other | Healthy volunteers |
Primary outcome
Cytokine detection
Time frame: 1-2 months
the detection of cytokines obtained by the different extraction solvents and sampling methods. ELISA complemented with the Micro BCA Protein Assay were used to quantify the cytokine recovery (in pg/ug total soluble protein).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- 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.
Warangkana Lohcharoenkal, PhD principal investigator
Essity Hygiene and Health AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy volunteers in people with Healthy, run by Essity Hygiene and Health AB at 1 site in Sweden.
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 6 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 12 Aug 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cytokine detection (time frame: 1-2 months). 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 12 Aug 2025.