Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus

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.

Study Overview

• Status: Terminated
• Conditions: Port-Wine Stain
• Intervention / Treatment: Drug: Sirolimus; Other: Erbium yag laser; Device: Pulsed Dye Laser

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015CA
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sirolimus topical 40microgram/cm2	Drug: Sirolimus; sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.; Other Names: Rapamune
Experimental: Pulsed Dye Laser + Erbium yag + sirolimus; Pulsed Dye Laser + Erbium yag laser + topical sirolimus	Drug: Sirolimus; sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.; Other Names: Rapamune; Other: Erbium yag laser; Er:Yag laser ablation of the stratum corneum; Device: Pulsed Dye Laser
Experimental: Pulsed Dye Laser + topical sirolimus	Drug: Sirolimus; sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.; Other Names: Rapamune; Device: Pulsed Dye Laser
Experimental: Pulsed Dye Laser	Device: Pulsed Dye Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage clearance assessed colorimetrically	10 weeks

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Martijn van Doorn, MD, PhD, Erasmus MC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Hemangioma; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: EMC14022_POLAR