WoundsPhase 2NCT01227759
Tyrosur® Gel-Investigation on Wound Healing Efficacy
A Phase 2 study testing Drug containing the active ingredient in people with Wounds and Wound Healing, run by Engelhard Arzneimittel GmbH & Co.KG.
Trial summary
This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wounds, Wound Healing
- What is being tested?
- Drug containing the active ingredient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 2010
- Phase
- Phase 2
- 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
- Men and women aged 18 years or older with healthy skin in the test area
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant for the outcome of the clinical trial;
- Written informed consent obtained.
Who cannot join
- acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
- dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- subjects with diabetes, psoriasis or lichen ruber planus;
- history of wound-healing complications, or keloid and hypertrophic scarring;
- evidence of drug or alcohol abuse;
- pregnancy or nursing;
Show all 10Show fewer
- symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
- known allergic reactions to components of the investigational product/s;
- treatment with systemic or locally acting medications which might counter or influence the trial aim within two weeks before the baseline visit (e.g. antihistamines or glucocorticosteroids);
- contraindications according to summary of product characteristics;
About this study
Official title: A Phase IIa, Single-center, Randomized, Observer-blind Trial With Intraindividual Comparison of Treated Versus Untreated to Assess the Wound Healing Efficacy of Topical Tyrosur® Gel
This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
Read the detailed description
This is a single-center, randomized, observer-blind phase IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
In the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. These wounds will then be treated with the investigational products. The wound healing will be clinically assessed and photographs will be taken for documentation.
- Conditions
- Wounds, Wound Healing
- Being tested
- Drug containing the active ingredient, Placebo
- 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.
Drug containing the active ingredientDrug
Also called Tyrosur® Gel
The topical application is performed once daily during a 12-day treatment.
PlaceboDrug
Also called Vehicle to Tyrosur® Gel
Placebo containing no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Not described Receives: Drug: Drug containing the active ingredient |
| Untreated | No intervention | Not described |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
Measured: 12 days
Secondary outcomes (1)
Clinical assessment of the wound healing efficacy of the vehicle compared to untreated using a score for wound healing rates; Photo documentation of the wound healing efficacy
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Walter Wigger-Alberti, MD, Principal investigator, Managing director bioskin, Hamburg Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227759
- Sponsor's protocol ID
- EA-10-1-042
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Single-center, Randomized, Observer-blind Trial With Intraindividual Comparison of Treated Versus Untreated to Assess the Wound Healing Efficacy of Topical Tyrosur® Gel
- ClinicalTrials.gov ID
- NCT01227759
- Acronym / sponsor ID
- EA-10-1-042
- Conditions
- Wounds, Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Oct 2010 (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.
This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
Detailed description
This is a single-center, randomized, observer-blind phase IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.
In the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. These wounds will then be treated with the investigational products. The wound healing will be clinically assessed and photographs will be taken for documentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Drug containing the active ingredient |
| Untreated | No intervention | – |
| Vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 18 years or older with healthy skin in the test area
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant for the outcome of the clinical trial;
- Written informed consent obtained.
Key exclusion criteria (10 listed)
- acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
- dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- subjects with diabetes, psoriasis or lichen ruber planus;
- history of wound-healing complications, or keloid and hypertrophic scarring;
- evidence of drug or alcohol abuse;
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 |
|---|---|---|
| Drug containing the active ingredientAlso: Tyrosur® GelThe topical application is performed once daily during a 12-day treatment. | Drug | Verum |
| PlaceboAlso: Vehicle to Tyrosur® GelPlacebo containing no active ingredient | Drug | Vehicle |
Primary outcome
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
Time frame: 12 days
1 secondary outcome
Clinical assessment of the wound healing efficacy of the vehicle compared to untreated using a score for wound healing rates; Photo documentation of the wound healing efficacy
Time frame: 12 days
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 26 Oct 2010.
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
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.
Walter Wigger-Alberti, MD principal investigator
Managing director bioskin, Hamburg Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug containing the active ingredient in people with Wounds and Wound Healing, run by Engelhard Arzneimittel GmbH & Co.KG.
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 10 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 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates (time frame: 12 days). 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 26 Oct 2010.