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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Port-Wine Stain

Intervention / Treatment
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* Drug: Sirolimus
* Other: Erbium yag laser
* Device: Pulsed Dye Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage clearance assessed colorimetrically |  | 10 weeks |