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

Primary Purpose

Port-Wine Stain

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Sirolimus

Erbium yag laser

Pulsed Dye Laser

About this trial

This is an interventional treatment trial for Port-Wine Stain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

sirolimus topical 40microgram/cm2

Pulsed Dye Laser + Erbium yag + sirolimus

Pulsed Dye Laser + topical sirolimus

Pulsed Dye Laser

Arm Description

sirolimus topical 40microgram/cm2

Pulsed Dye Laser + Erbium yag laser + topical sirolimus

Pulsed Dye Laser + topical sirolimus

Pulsed Dye Laser

Outcomes

Primary Outcome Measures

Percentage clearance assessed colorimetrically

Secondary Outcome Measures

Full Information

NCT ID

NCT02214706

First Posted

August 11, 2014

Last Updated

February 7, 2017

Sponsor

Erasmus Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02214706

Brief Title

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

Official Title

Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus in an Open Label Pilot Study (POLAR).

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy / adverse events

Study Start Date

July 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erasmus Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Port-Wine Stain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sirolimus topical 40microgram/cm2

Arm Type

Experimental

Arm Description

sirolimus topical 40microgram/cm2

Arm Title

Pulsed Dye Laser + Erbium yag + sirolimus

Arm Type

Experimental

Arm Description

Pulsed Dye Laser + Erbium yag laser + topical sirolimus

Arm Title

Pulsed Dye Laser + topical sirolimus

Arm Type

Experimental

Arm Description

Pulsed Dye Laser + topical sirolimus

Arm Title

Pulsed Dye Laser

Arm Type

Experimental

Arm Description

Pulsed Dye Laser

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

Rapamune

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Erbium yag laser

Intervention Description

Er:Yag laser ablation of the stratum corneum

Intervention Type

Device

Intervention Name(s)

Pulsed Dye Laser

Primary Outcome Measure Information:

Title

Percentage clearance assessed colorimetrically

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martijn van Doorn, MD, Phd

Organizational Affiliation

Erasmus Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erasmus MC

City

Rotterdam

State/Province

Zuid-Holland

ZIP/Postal Code

3015CA

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

27320685

Citation

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.

Results Reference

derived

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

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