Healthy SkinNCT03625167
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
A study testing Treatment with petrolatum in people with Healthy Skin, run by Prof. Dr. Jan Kottner at 1 site in Germany.
Trial summary
The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- Treatment with petrolatum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 85 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)
- Female,
- 65 to 85 years,
- Caucasian,
- Phototype I to III according to the Fitzpatrick classification,
- Body Mass Index between 20 and 28 kg/m2,
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- Non-smoker of at least one year,
- Absence of skin diseases or scars in the skin area of interest,
- Absence of tattoos in the skin area of interest,
- Able to give written informed consent,
- Willing and able to fulfill the study requirements
Who cannot join
- Known or suspected defect of healing,
- Diabetes mellitus
- Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,
- Acute or chronic wounds in the skin area of interest,
- Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas,
- Medical history of skin cancer,
Show all 15Show fewer
- History or establishment of diabetes or pre-diabetes,
- Any hyper-sensibility to one of the compounds of the investigational product,
- Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 3 and Visit 5), one NSAID to treat headache within four days is allowed
- Any physical treatment (like laser or surgery) on the arms within the last 6 months,
- Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments,
- Allergy to band-aid or to metals (such as nickel),
- UV sessions or strong sun exposure of the arms during the study period,
- Subject who cannot be contacted easily in case of necessity,
- Current participation in any other clinical study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charite University Berlin
Berlin, 10117
About this study
Official title: An Exploratory Randomized Controlled Study to Evaluate the Effect of a Basic Skin Care Product on the Structural Strength of the Dermo-epidermal Junction
The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.
Read the detailed description
The process of aging involves numerous structural and functional changes also affecting the skin. The skin fulfills a variety of protective and regulatory functions. Compared to other organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic factors these external factors may accelerate skin aging. Due to its ageing-related loss of functional capacity the skin becomes susceptible to develop adverse skin conditions and dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care depended, and severely ill individuals are at high risk for developing severe skin injuries and wounds (e.g. decubitus, skin tears) with high social and economic impact. Empirical evidence indicates that the reduced adhesion of the dermal-epidermal junction is a major pathophysiological predictor for these types of injuries.
The suction blister model is an artificial and controlled technique for dermal-epidermal separation along the dermo-epidermal junction (DEJ). Empirical evidence suggests that the time of the dermal-epidermal separation (blistering time) is a measure of the dermo-epidermal adhesion. It has been proposed that the blistering time might be a clinically relevant parameter reflecting the mechanical integrity/stability of the dermo-epidermal junction.
Clinical practice guidelines recommend the use of topical skin care products to reduce the risk for pressure ulcer and skin tear development. However, the underlying working mechanisms of most basic skin care products are poorly understood. It is known that topically applied skin care products exhibit physical and chemical effects on and in the uppermost skin layers (e.g. the stratum corneum). Despite a few well known active ingredients (e.g. retinoids, vitamin C) exhibiting effects in the dermis, a particular skin protective effect of the vast majority of daily basic skin care applications on these deeper skin layers is unknown. The primary objective of this study is to test, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.
- Conditions
- Healthy Skin
- Being tested
- Treatment with petrolatum
- Keywords
- skin ageing, suction blister, dermo-epidermal junction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with petrolatumOther
Petrolatum is applied twice daily to the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with petrolatum | Experimental | In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks. Receives: Other: Treatment with petrolatum |
| Control | No intervention | The control forearm will remain untreated throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blistering Time (Full Blister)
Duration from the start of suction pressure to the development of a full blister (measured in minutes)
Measured: Day 28±2, Day 56±2
Blistering Time (First Vesicles)
Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)
Measured: Day 28±2, Day 56±2
Secondary outcomes (3)
Epidermal Thickness
Optical coherence tomography (OCT) will be used to quantitatively measure changes of the epidermal thickness on the volar forearm
Measured: Baseline, Day 28±2, Day 56±2
Epidermal Hydratation: Stratum Corneum Hydration
Stratum corneum hydration (SCH) was measured with Corneometer® CM 825 (Courage \& Khazaka electronic GmbH, Cologne, Germany) and expressed in arbitrary units (AU) (range 0-120 AU) on the volar forearm. Lower values represent reduced skin hydration in the upper skin layer.
Measured: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
Epidermal Hydratation: Epidermal Moisture
Epidermal Moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Measured: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start31 Jul 2018
- Primary completion11 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SkinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jan Kottner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Jan Kottner, Charite University, Berlin, Germany
- Investigators
- Jan Kottner, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625167
- Sponsor's protocol ID
- CRC-SP-A31
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2018
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Genedy-Kalyoncu M, Richter C, Surber C, Blume-Peytavi U, Kottner J. The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial. Int Wound J. 2022 Feb;19(2):426-435. doi: 10.1111/iwj.13643. Epub 2021 Jun 13.
PubMed 34121334
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Controlled Study to Evaluate the Effect of a Basic Skin Care Product on the Structural Strength of the Dermo-epidermal Junction
- ClinicalTrials.gov ID
- NCT03625167
- Acronym / sponsor ID
- CRC-SP-A31
- Conditions
- Healthy Skin
- Keywords
- skin ageing, suction blister, dermo-epidermal junction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Prof. Dr. Jan KottnerUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.
Detailed description
The process of aging involves numerous structural and functional changes also affecting the skin. The skin fulfills a variety of protective and regulatory functions. Compared to other organs, the skin is constantly exposed to harmful environmental influences. Besides intrinsic factors these external factors may accelerate skin aging. Due to its ageing-related loss of functional capacity the skin becomes susceptible to develop adverse skin conditions and dermatological diseases (e.g. skin dryness, fungal infections). Especially old aged, care depended, and severely ill individuals are at high risk for developing severe skin injuries and wounds (e.g. decubitus, skin tears) with high social and economic impact. Empirical evidence indicates that the reduced adhesion of the dermal-epidermal junction is a major pathophysiological predictor for these types of injuries.
The suction blister model is an artificial and controlled technique for dermal-epidermal separation along the dermo-epidermal junction (DEJ). Empirical evidence suggests that the time of the dermal-epidermal separation (blistering time) is a measure of the dermo-epidermal adhesion. It has been proposed that the blistering time might be a clinically relevant parameter reflecting the mechanical integrity/stability of the dermo-epidermal junction.
Clinical practice guidelines recommend the use of topical skin care products to reduce the risk for pressure ulcer and skin tear development. However, the underlying working mechanisms of most basic skin care products are poorly understood. It is known that topically applied skin care products exhibit physical and chemical effects on and in the uppermost skin layers (e.g. the stratum corneum). Despite a few well known active ingredients (e.g. retinoids, vitamin C) exhibiting effects in the dermis, a particular skin protective effect of the vast majority of daily basic skin care applications on these deeper skin layers is unknown. The primary objective of this study is to test, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with petrolatum | Experimental | Other: Treatment with petrolatumIn each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks. |
| Control | No intervention | –The control forearm will remain untreated throughout the study. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)
- Female,
- 65 to 85 years,
- Caucasian,
- Phototype I to III according to the Fitzpatrick classification,
Key exclusion criteria (15 listed)
- Known or suspected defect of healing,
- Diabetes mellitus
- Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,
- Acute or chronic wounds in the skin area of interest,
- Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas,
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 |
|---|---|---|
| Treatment with petrolatumPetrolatum is applied twice daily to the intervention arm. | Other | Treatment with petrolatum |
Primary outcome
Blistering Time (Full Blister)
Time frame: Day 28±2, Day 56±2
Duration from the start of suction pressure to the development of a full blister (measured in minutes)
Blistering Time (First Vesicles)
Time frame: Day 28±2, Day 56±2
Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)
3 secondary outcomes
Epidermal Thickness
Time frame: Baseline, Day 28±2, Day 56±2
Epidermal Hydratation: Stratum Corneum Hydration
Time frame: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
Epidermal Hydratation: Epidermal Moisture
Time frame: Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34121334El Genedy-Kalyoncu M, Richter C, Surber C, Blume-Peytavi U, Kottner J. The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial. Int Wound J. 2022 Feb;19(2):426-435. doi: 10.1111/iwj.13643. Epub 2021 Jun 13.
- 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.
Jan Kottner, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with petrolatum in people with Healthy Skin, run by Prof. Dr. Jan Kottner 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 11 inclusion and 15 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 19 Feb 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?
Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blistering Time (Full Blister) (time frame: Day 28±2, Day 56±2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625167, which also lists 1 linked publication.
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 19 Feb 2025.