Post Dermatological Surgery ScarsNCT01910896
Effectiveness and Safety Study of Overnight Intensive Patch in Scars
A study testing Overnight Intensive Patch in people with Post Dermatological Surgery Scars, run by Merz Pharmaceuticals GmbH at 9 sites in Germany.
Trial summary
To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post dermatological surgery scars and its safety over 12 to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Dermatological Surgery Scars
- What is being tested?
- Overnight Intensive Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 9 sitesGermany
- Study dates
- Oct 2013to Jul 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has two or more newly formed post dermatological surgery scars of 1-10 (inclusive) cm each, with comparable length, located on a comparable skin area (upon the discretion of the investigator, considering e.g. the skin thickness or body tension). Scars located at the upper back of the body will not be investigated due to a higher risk of wound dehiscence.
- The dermatological surgery takes place within the last 3 weeks prior to baseline visit and the baseline visit is on the day of post-surgery control with optional suture removal, the wound must be closed by then.
Who cannot join
- Subject with known history of keloids or hypertrophic scars.
- Subject with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/ deep chemical peeling, dermabrasion treatments or laser therapy in the skin area intended to be treated for less than 8 weeks prior to screening/ baseline visit.
- Subject with any planned topical application containing active ingredients (e.g. self-tanning agents, however, hydration lotion is allowed provided the scars are left free) in the skin area intended to be treated.
- Subject anticipated spending excessive time in the sun (e.g. outdoor workers) or in the sun tanning bed during the investigation.
- Subject with any infection or wound in the area intended to be treated.
- Subject with known hypersensitivity to any ingredient of OIP (e.g. acrylic adhesive, extractum cepae or allantoin).
Show all 9Show fewer
- Subject who is taking, or anticipated to take during the investigation, systemic corticosteroids or topical corticosteroids applied on the investigation skin area.
- Subject with eczema requiring treatment in the skin area intended to be treated.
- Subject with any ongoing severe or uncontrolled systemic disease (cardiac, respiratory, hepatic, renal or gastrointestinal), malignant tumor (except for basalioma), or known HIV infection.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Merz Investigational Site # 0490341
Augsburg, 86179
Merz Investigational Site # 0490312
Berlin, 10117
Merz Investigational Site # 049307
Hamburg, 20354
Merz Investigational Site #0490345
Hamburg, 22609
Merz Investigational Site # 0490101
Mahlow, 15831
Merz Investigational Site #0490340
Mainz, 55131
Merz Investigational Site # 049112
München, 80337
Merz Investigational Site # 049331
Münster, 48157
Merz Investigational Site # 0490321
Schweinfurt, 97421
About this study
Official title: A Prospective, Intra-individual Randomized, Observer-blind, Controlled Investigation to Investigate the Effectiveness and Safety of Overnight Intensive Patch (OIP) Over 12 to 24 Weeks in Post Dermatological Surgery Scars
To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post dermatological surgery scars and its safety over 12 to 24 weeks.
- Conditions
- Post Dermatological Surgery Scars
- Being tested
- Overnight Intensive Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight Intensive PatchDevice
Eligible subjects will have their two scars randomized for OIP application/no treatment. OIP for overnight application (at least 6 hours) for 12 to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Overnight Intensive Patch | Experimental | Overnight intensive patch (OIP), on polyolefin foam basis containing acrylate, extractum cepae and allantoin is a class I, CE (Conformité Européenne) marked medical device. Subjects will have their two scars randomized for Overnight Intensive Patch application versus no treatment. Receives: Device: Overnight Intensive Patch |
| No treatment | No intervention | Subjects serve as their own control. Eligible subjects have two comparable scars in same body regions, one scar will be treated with Overnight Intensive Patch, the second scar will not be treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from screening/baseline in the total score of observer evaluated POSAS [Patient and Observer Scar Assessment Scale] to week 12
The POSA scale consists of two scales which need to be filled out by the observer and the subject, respectively. The scale will be rated for both scars of the same subject by observer and the subject independently in all planned visits.
Observer Scar Assessment: The observer assesses the following items on a scale from 1 (normal skin) to 10 (worst imaginable skin): Vascularization, Pigmentation, Thickness, Relief, Pliability.
Patient Scar Assessment: The subject answers the following questions on a scale from 1 (no, no complaints) to 10 (yes, worst imaginable): Is the scar painful?, Is the scar itching?; The subject answers the following questions on a scale from 1 (no, as normal skin) to 10 (yes, very different): Is the color of the scar different?, Is the scar more stiff?, Is the thickness of the scar different?, Is the scar irregular?
Measured: Baseline to week 12
Secondary outcomes (2)
Absolute change from screening/baseline in the total score of patient evaluated POSAS to week 12
Measured: Baseline to week 12
Absolute change from screening/baseline in the total score of observer evaluated POSAS to week 24
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dermatological Surgery ScarsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910896
- Sponsor's protocol ID
- MRZ90011_0028_3
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Intra-individual Randomized, Observer-blind, Controlled Investigation to Investigate the Effectiveness and Safety of Overnight Intensive Patch (OIP) Over 12 to 24 Weeks in Post Dermatological Surgery Scars
- ClinicalTrials.gov ID
- NCT01910896
- Acronym / sponsor ID
- MRZ90011_0028_3
- Conditions
- Post Dermatological Surgery Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- 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.
To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post dermatological surgery scars and its safety over 12 to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overnight Intensive Patch | Experimental | Device: Overnight Intensive PatchOvernight intensive patch (OIP), on polyolefin foam basis containing acrylate, extractum cepae and allantoin is a class I, CE (Conformité Européenne) marked medical device. Subjects will have their two scars randomized for Overnight Intensive Patch application versus no treatment. |
| No treatment | No intervention | –Subjects serve as their own control. Eligible subjects have two comparable scars in same body regions, one scar will be treated with Overnight Intensive Patch, the second scar will not be treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has two or more newly formed post dermatological surgery scars of 1-10 (inclusive) cm each, with comparable length, located on a comparable skin area (upon the discretion of the investigator, considering e.g. the skin thickness or body tension). Scars located at the upper back of the body will not be investigated due to a higher risk of wound dehiscence.
- The dermatological surgery takes place within the last 3 weeks prior to baseline visit and the baseline visit is on the day of post-surgery control with optional suture removal, the wound must be closed by then.
Key exclusion criteria (9 listed)
- Subject with known history of keloids or hypertrophic scars.
- Subject with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/ deep chemical peeling, dermabrasion treatments or laser therapy in the skin area intended to be treated for less than 8 weeks prior to screening/ baseline visit.
- Subject with any planned topical application containing active ingredients (e.g. self-tanning agents, however, hydration lotion is allowed provided the scars are left free) in the skin area intended to be treated.
- Subject anticipated spending excessive time in the sun (e.g. outdoor workers) or in the sun tanning bed during the investigation.
- Subject with any infection or wound in the area intended to be treated.
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 |
|---|---|---|
| Overnight Intensive PatchEligible subjects will have their two scars randomized for OIP application/no treatment. OIP for overnight application (at least 6 hours) for 12 to 24 weeks. | Device | Overnight Intensive Patch |
Primary outcome
Absolute change from screening/baseline in the total score of observer evaluated POSAS [Patient and Observer Scar Assessment Scale] to week 12
Time frame: Baseline to week 12
The POSA scale consists of two scales which need to be filled out by the observer and the subject, respectively. The scale will be rated for both scars of the same subject by observer and the subject independently in all planned visits. Observer Scar Assessment: The observer assesses the following items on a scale from 1 (normal skin) to 10 (worst imaginable skin): Vascularization, Pigmentation, Thickness, Relief, Pliability. Patient Scar Assessment: The subject answers the following questions on a scale from 1 (no, no complaints) to 10 (yes, worst imaginable): Is the scar painful?, Is the scar itching?; The subject answers the following questions on a scale from 1 (no, as normal skin) to 10 (yes, very different): Is the color of the scar different?, Is the scar more stiff?, Is the thickness of the scar different?, Is the scar irregular?
2 secondary outcomes
Absolute change from screening/baseline in the total score of patient evaluated POSAS to week 12
Time frame: Baseline to week 12
Absolute change from screening/baseline in the total score of observer evaluated POSAS to week 24
Time frame: Baseline to week 24
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 9 Sep 2015.
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.
Merz Medical Expert study director
Merz Pharmaceuticals GmbH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight Intensive Patch in people with Post Dermatological Surgery Scars, run by Merz Pharmaceuticals GmbH at 9 sites 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 2 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Absolute change from screening/baseline in the total score of observer evaluated POSAS [Patient and Observer Scar Assessment Scale] to week 12 (time frame: Baseline to week 12). 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 9 Sep 2015.