HealthyNCT04687839
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
A study testing Induction of suction blister, Transepidermal water loss (TEWL) and Macrophotography in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Germany.
Trial summary
The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Induction of suction blister, Transepidermal water loss (TEWL) and Macrophotography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2020to 17 Aug 2020
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject with a phototype I, II or III according to the Fitzpatrick scale
- Subject aged between 18 and 45 years included at selection visit
- Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results
Who cannot join
- History of keloids and hypertrophic scars
- Subject with removal of axillary lymph nodes
- Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
- Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
- Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
- Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
- Subject with congenital methemoglobinemia or porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.
The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.
- Conditions
- Healthy
- Being tested
- Induction of suction blister, Transepidermal water loss (TEWL), Macrophotography, Wound healing medical device
- Keywords
- Heaklthy adult subject, Wound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of suction blisterProcedure or surgery
For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.
Transepidermal water loss (TEWL)Other
- At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
- For subsequent visits, before product application
MacrophotographyOther
- At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
- For subsequent visits, before product application
Wound healing medical deviceDevice
Twice daily application on superficial wounds
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult subjects | Experimental | It's a randomized intra-individual comparative study with two injured study areas (treated and untreated) for each subject.
The randomization will determine the application side on which the tested product will be applied (RIGHT or LEFT forearm).
Twice daily application on the treated area. Receives: Procedure: Induction of suction blister; Other: Transepidermal water loss (TEWL); Other: Macrophotography; Device: Wound healing medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the tested product on the wound healing at D6
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
Measured: Day6
Secondary outcomes (3)
Effect of the tested product on the cutaneous barrier restoration
By measuring the TEWL (Trans Epidermal Water Loss) on treated area compared to an untreated area
Measured: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Effect of the tested product on healing
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
Measured: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Tolerance of the tested product
By measuring the occurence of adverse event
Measured: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start13 Jul 2020
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, Dr., Principal investigator, Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687839
- Sponsor's protocol ID
- RL3010A2019001
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 2020
- Last updated
- 19 Mar 2021
- 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT04687839
- Acronym / sponsor ID
- RL3010A2019001
- Conditions
- Healthy
- Keywords
- Heaklthy adult subject, Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 29 Dec 2020 (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.
The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult subjects | Experimental | Procedure: Induction of suction blister, Other: Transepidermal water loss (TEWL), Other: Macrophotography, Device: Wound healing medical deviceIt's a randomized intra-individual comparative study with two injured study areas (treated and untreated) for each subject. The randomization will determine the application side on which the tested product will be applied (RIGHT or LEFT forearm). Twice daily application on the treated area. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject with a phototype I, II or III according to the Fitzpatrick scale
- Subject aged between 18 and 45 years included at selection visit
- Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results
Key exclusion criteria (7 listed)
- History of keloids and hypertrophic scars
- Subject with removal of axillary lymph nodes
- Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
- Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
- Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
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 |
|---|---|---|
| Induction of suction blisterFor each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model. | Procedure or surgery | Healthy adult subjects |
| Transepidermal water loss (TEWL)* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application | Other | Healthy adult subjects |
| Macrophotography* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application | Other | Healthy adult subjects |
| Wound healing medical deviceTwice daily application on superficial wounds | Device | Healthy adult subjects |
Primary outcome
Effect of the tested product on the wound healing at D6
Time frame: Day6
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
3 secondary outcomes
Effect of the tested product on the cutaneous barrier restoration
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Effect of the tested product on healing
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Tolerance of the tested product
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
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 19 Mar 2021.
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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.
Kirstin Deuble-Bente, Dr. principal investigator
Kiebitzweg 2, 22869 Schenefeld/Hamburg, 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 Induction of suction blister, Transepidermal water loss (TEWL) and Macrophotography in people with Healthy, run by Pierre Fabre Dermo Cosmetique 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 3 inclusion and 7 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 Mar 2021. 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?
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?
Effect of the tested product on the wound healing at D6 (time frame: Day6). 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 19 Mar 2021.