Port-Wine StainNCT02214706
Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus
A study testing Sirolimus, Erbium yag laser and Pulsed Dye Laser in people with Port-Wine Stain, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to improve the therapeutic outcome of laser therapy for port wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser and topical sirolimus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Sirolimus, Erbium yag laser and Pulsed Dye Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent;
- Subject is ≥ 18 years of age at time of screening;
- Subject has an extra-facial homogenous Port Wine Stain (PWS);
- The PWS is large enough in size to fit one of the templates
- Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment area);
- The PWS has a minimal erythema grading score of 3 (on a 4 point scale) in the opinion of the investigator;
- Screening blood safety values are within normal parameters or regarded as not clinically significant in the opinion of the investigator.
Who cannot join
- PWS with a nodular/hypertrophic component in the treatment area;
- PWS on cosmetically unacceptable locations in the opinion of the investigator;
- For women: pregnant or breast feeding during the treatment period;
- Women of child-bearing potential, unless they are using adequate contraceptive measures
- Subject is known to have immune deficiency, or is immune compromised
- Known allergy to sirolimus or other constituents of the study medication;
- Incapacitated subjects;
- Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).
The purpose of this study is to improve the therapeutic outcome of laser therapy for port wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser and topical sirolimus.
Read the detailed description
In the first treatment period all patients will receive a total of five treatments with two week intervals. Every patient will receive the following four treatments (utilizing a template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment followed by topical sirolimus application without Er:Yag laser ablation of the stratum corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months follow-up period, during the second treatment period, patients will receive an additional five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the most successful of the four treatment modalities as evaluated after the first treatment period.
- Conditions
- Port-Wine Stain
- Being tested
- Sirolimus, Erbium yag laser, Pulsed Dye Laser
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune
sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.
Erbium yag laserOther
Er:Yag laser ablation of the stratum corneum
Pulsed Dye LaserDevice
| Study group | Role | What they receive |
|---|---|---|
| sirolimus topical 40microgram/cm2 | Experimental | sirolimus topical 40microgram/cm2 Receives: Drug: Sirolimus |
| Pulsed Dye Laser + Erbium yag + sirolimus | Experimental | Pulsed Dye Laser + Erbium yag laser + topical sirolimus Receives: Drug: Sirolimus; Other: Erbium yag laser; Device: Pulsed Dye Laser |
| Pulsed Dye Laser + topical sirolimus | Experimental | Pulsed Dye Laser + topical sirolimus Receives: Drug: Sirolimus; Device: Pulsed Dye Laser |
| Pulsed Dye Laser | Experimental | Pulsed Dye Laser Receives: Device: Pulsed Dye Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage clearance assessed colorimetrically
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionDec 2016
Why it stopped: Lack of efficacy / adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Port-Wine StainStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.B.A. van Doorn, Erasmus Medical Center
- Investigators
- Martijn van Doorn, MD, Phd, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214706
- Sponsor's protocol ID
- EMC14022_POLAR
- Status last verified
- Feb 2017
- First submitted
- 11 Aug 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Greveling K, Prens EP, van Doorn MB. Treatment of port wine stains using Pulsed Dye Laser, Erbium YAG Laser, and topical rapamycin (sirolimus)-A randomized controlled trial. Lasers Surg Med. 2017 Jan;49(1):104-109. doi: 10.1002/lsm.22548. Epub 2016 Jun 20.
PubMed 27320685
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).
- ClinicalTrials.gov ID
- NCT02214706
- Acronym / sponsor ID
- EMC14022_POLAR
- Conditions
- Port-Wine Stain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy / adverse events
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Aug 2014 (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.
The purpose of this study is to improve the therapeutic outcome of laser therapy for port wine stains by using a combination treatment of the pulsed dye laser (PDL), erbium yag laser and topical sirolimus.
Detailed description
In the first treatment period all patients will receive a total of five treatments with two week intervals. Every patient will receive the following four treatments (utilizing a template with separate squares of 1cm2): 1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum compared with 2) PDL treatment followed by topical sirolimus application without Er:Yag laser ablation of the stratum corneum, 3) PDL treatment only and 4) sirolimus application only. After the six months follow-up period, during the second treatment period, patients will receive an additional five treatments of the adjacent cosmetic unit of the treated part of the PWS, employing the most successful of the four treatment modalities as evaluated after the first treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sirolimus topical 40microgram/cm2 | Experimental | Drug: Sirolimussirolimus topical 40microgram/cm2 |
| Pulsed Dye Laser + Erbium yag + sirolimus | Experimental | Drug: Sirolimus, Other: Erbium yag laser, Device: Pulsed Dye LaserPulsed Dye Laser + Erbium yag laser + topical sirolimus |
| Pulsed Dye Laser + topical sirolimus | Experimental | Drug: Sirolimus, Device: Pulsed Dye LaserPulsed Dye Laser + topical sirolimus |
| Pulsed Dye Laser | Experimental | Device: Pulsed Dye LaserPulsed Dye Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has provided informed consent;
- Subject is ≥ 18 years of age at time of screening;
- Subject has an extra-facial homogenous Port Wine Stain (PWS);
- The PWS is large enough in size to fit one of the templates
- Subject has not received any laser treatment of the PWS in the last 3 months (in the treatment area);
Key exclusion criteria (8 listed)
- PWS with a nodular/hypertrophic component in the treatment area;
- PWS on cosmetically unacceptable locations in the opinion of the investigator;
- For women: pregnant or breast feeding during the treatment period;
- Women of child-bearing potential, unless they are using adequate contraceptive measures
- Subject is known to have immune deficiency, or is immune compromised
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 |
|---|---|---|
| SirolimusAlso: Rapamunesirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days. | Drug | Pulsed Dye Laser + Erbium yag + sirolimus, Pulsed Dye Laser + topical sirolimus, sirolimus topical 40microgram/cm2 |
| Erbium yag laserEr:Yag laser ablation of the stratum corneum | Other | Pulsed Dye Laser + Erbium yag + sirolimus |
| Pulsed Dye Laser | Device | Pulsed Dye Laser, Pulsed Dye Laser + Erbium yag + sirolimus, Pulsed Dye Laser + topical sirolimus |
Primary outcome
Percentage clearance assessed colorimetrically
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Lack of efficacy / adverse events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Derived from this study: PubMed 27320685Greveling K, Prens EP, van Doorn MB. Treatment of port wine stains using Pulsed Dye Laser, Erbium YAG Laser, and topical rapamycin (sirolimus)-A randomized controlled trial. Lasers Surg Med. 2017 Jan;49(1):104-109. doi: 10.1002/lsm.22548. Epub 2016 Jun 20.
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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.
Martijn van Doorn, MD, Phd principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus, Erbium yag laser and Pulsed Dye Laser in people with Port-Wine Stain, run by Erasmus Medical Center at 1 site in Netherlands.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Feb 2017. 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 Netherlands. 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 was stopped early (reason given: Lack of efficacy / adverse events). Results are not available in the source record.
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?
Percentage clearance assessed colorimetrically (time frame: 10 weeks). 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 NCT02214706, 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 8 Feb 2017.