Intact SkinNCT04192123
Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability
A study testing HM242 in people with Intact Skin, run by B. Braun Ltd. Centre of Excellence Infection Control at 1 site in Germany.
Trial summary
It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intact Skin
- What is being tested?
- HM242
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 2020to 19 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy male or female subjects aged ≥ 18 years and ≤ 65 years.
- Healthy skin on the upper arms
- Skin type visually assessed from pale white to light brown
- Females with childbearing potential must have a negative urine pregnancy test at baseline and must agree to use a highly effective method of contraception for the duration of the clinical investigation.
- Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial prior to any trial-related activity and that all information has been understood
Who cannot join
- Breastfeeding or pregnant women
- Extremely tanned skin that may interfere with the tolerability assessment based on Investigator judgment
- Subjects with known or suspected allergies or skin hypersensitivity (e.g. acute dermatitis)
- Subjects with known or suspected allergies or hypersensitivity to any of the components of the Investigational Medical Devices
- Any illness or circumstance that could affect the trial purpose in the opinion of the investigator (e.g. intensive UV exposure)
- Dermatologic diseases or skin conditions (e.g. tattoos, multiple birth marks in the test area) that might interfere with the evaluation of test site reaction
Show all 9Show fewer
- Within 3 weeks prior to Day 1 and during the entire trial: Any systemic or topical medication or therapy likely to interfere with the trial purposes: e.g. immune-modulating or immunosuppressive therapy (e.g. corticosteroids, cytotoxics, cyclosporine or radiotherapy).
- Within 7 days prior to Day 1 and during the entire trial: any topical dermatological agents applied on the upper arms (drugs or medical device), except usual skin care preparations and skin cleansing preparations like anionic tensides, cleansing soaps ointments, oils, enzymes, etc. (not allowed on test areas during the trial)
- During the entire trial: exposure to sunlight that could lead to sunburns or photo sensibilization reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Monocentric, Open-Label Test of the HM242 Wound and Irrigation Solution and Gel on Healthy Skin to Evaluate Safety and Local Tolerability
It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound.
The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin.
This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.
Read the detailed description
The objective of this study is to assess the local tolerability and safety of HM242-Solution and HM242-Gel after their application under occlusion on intact skin.
- Conditions
- Intact Skin
- Being tested
- HM242
- Keywords
- Physical rinsing, Cleansing solution, Wound bed preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM242Device
HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All patients will receive an occlusive patch per test treatment as follows:
* Treatment 1: HM242-Solution
* Treatment 2: HM242-Gel
* Treatment 3: HM242-Solution and HM242-Gel
* Treatment 4: Irritant control (sodium lauryl sulfate (SLS))
* Treatment 5: Negative control Receives: Device: HM242 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of related Adverse Events from Study Start until the End of Study (EoS)
to assess safety of HM242-Solution and HM242-Gel in healthy subjects which will be assessed in terms of related adverse events occurrence during the study (as reported by subjects and/or observed by the investigator)
Measured: Day 1 to Day 10
Secondary outcomes (1)
Post treatment assessment (via patch test scoring system provided by International Contact Dermatitis Research Group) by the Investigator. Scoring system: "-" no reaction; "Ir" irritative reaction (vesicles, blister, necrosis)
to assess local tolerability of HM242-Solution and HM242-Gel in healthy subjects which will be assessed by the investigator using the patch test
Measured: Day 3, Day 4, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start25 May 2020
- Primary completion19 Jun 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intact 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Welf Prager, Dr. med, Principal investigator, Dermatologische Praxis Prager & Partner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192123
- Sponsor's protocol ID
- OPM-G-H-1902
- Status last verified
- Jul 2020
- First submitted
- 6 Dec 2019
- Last updated
- 17 Jul 2020
- 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Monocentric, Open-Label Test of the HM242 Wound and Irrigation Solution and Gel on Healthy Skin to Evaluate Safety and Local Tolerability
- ClinicalTrials.gov ID
- NCT04192123
- Acronym / sponsor ID
- OPM-G-H-1902
- Conditions
- Intact Skin
- Keywords
- Physical rinsing, Cleansing solution, Wound bed preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- 25 May 2020 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 10 Dec 2019 (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.
It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound.
The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin.
This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.
Detailed description
The objective of this study is to assess the local tolerability and safety of HM242-Solution and HM242-Gel after their application under occlusion on intact skin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: HM242All patients will receive an occlusive patch per test treatment as follows: * Treatment 1: HM242-Solution * Treatment 2: HM242-Gel * Treatment 3: HM242-Solution and HM242-Gel * Treatment 4: Irritant control (sodium lauryl sulfate (SLS)) * Treatment 5: Negative control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally healthy male or female subjects aged ≥ 18 years and ≤ 65 years.
- Healthy skin on the upper arms
- Skin type visually assessed from pale white to light brown
- Females with childbearing potential must have a negative urine pregnancy test at baseline and must agree to use a highly effective method of contraception for the duration of the clinical investigation.
- Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial prior to any trial-related activity and that all information has been understood
Key exclusion criteria (9 listed)
- Breastfeeding or pregnant women
- Extremely tanned skin that may interfere with the tolerability assessment based on Investigator judgment
- Subjects with known or suspected allergies or skin hypersensitivity (e.g. acute dermatitis)
- Subjects with known or suspected allergies or hypersensitivity to any of the components of the Investigational Medical Devices
- Any illness or circumstance that could affect the trial purpose in the opinion of the investigator (e.g. intensive UV exposure)
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 |
|---|---|---|
| HM242HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm. | Device | Experimental |
Primary outcome
Occurrence of related Adverse Events from Study Start until the End of Study (EoS)
Time frame: Day 1 to Day 10
to assess safety of HM242-Solution and HM242-Gel in healthy subjects which will be assessed in terms of related adverse events occurrence during the study (as reported by subjects and/or observed by the investigator)
1 secondary outcome
Post treatment assessment (via patch test scoring system provided by International Contact Dermatitis Research Group) by the Investigator. Scoring system: "-" no reaction; "Ir" irritative reaction (vesicles, blister, necrosis)
Time frame: Day 3, Day 4, Day 5
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 17 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Intact Skin
Not yet recruiting
Effect of FPP on Cutaneous Barrier Integrity
Skin Barrier Dysfunction, Healthy Volunteers
Not yet recruiting
Dermatological Effects and Quality of Life in Oncology Patients
Breast Cancer, Ovarian Cancer
Not yet recruiting
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Microbial Contamination, Environmental Contamination
Recruiting
Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis
Atopic Dermatitis
Not yet recruiting
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
Breast Cancer, Early-Stage Breast Carcinoma
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.
Welf Prager, Dr. med principal investigator
Dermatologische Praxis Prager & Partner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HM242 in people with Intact Skin, run by B. Braun Ltd. Centre of Excellence Infection Control 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 5 inclusion and 9 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 17 Jul 2020. 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?
Occurrence of related Adverse Events from Study Start until the End of Study (EoS) (time frame: Day 1 to Day 10). 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 17 Jul 2020.