NCT02214706

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

August 11, 2014

Last Update Submit

February 7, 2017

Conditions

Port-Wine Stain

Outcome Measures

Primary Outcomes (1)

  • Percentage clearance assessed colorimetrically

    10 weeks

Study Arms (4)

sirolimus topical 40microgram/cm2

EXPERIMENTAL

sirolimus topical 40microgram/cm2

Drug: Sirolimus

Pulsed Dye Laser + Erbium yag + sirolimus

EXPERIMENTAL

Pulsed Dye Laser + Erbium yag laser + topical sirolimus

Drug: SirolimusOther: Erbium yag laserDevice: Pulsed Dye Laser

Pulsed Dye Laser + topical sirolimus

EXPERIMENTAL

Pulsed Dye Laser + topical sirolimus

Drug: SirolimusDevice: Pulsed Dye Laser

Pulsed Dye Laser

EXPERIMENTAL

Pulsed Dye Laser

Device: Pulsed Dye Laser

Interventions

SirolimusDRUG

sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.

Also known as: Rapamune
Pulsed Dye Laser + Erbium yag + sirolimusPulsed Dye Laser + topical sirolimussirolimus topical 40microgram/cm2
Erbium yag laserOTHER

Er:Yag laser ablation of the stratum corneum

Pulsed Dye Laser + Erbium yag + sirolimus
Pulsed Dye LaserDEVICE
Pulsed Dye LaserPulsed Dye Laser + Erbium yag + sirolimusPulsed Dye Laser + topical sirolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015CA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 27320685DERIVED

MeSH Terms

Conditions

Port-Wine Stain

Interventions

SirolimusLasers, Solid-StateLasers, Dye

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Martijn van Doorn, MD, Phd

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 12, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

NL(1)