An interventional study of Sirolimus and Erbium yag laser in Port-Wine Stain, sponsored by Erasmus Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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.
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.
83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.
This study's enrollment of 17 is below the median of 33 across 56 interventional studies indexed under Hemangioma, Capillary.
Browse Hemangioma, Capillary studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Exclusion Criteria:
sirolimus topical 40microgram/cm2
Drug: Sirolimus
Pulsed Dye Laser + Erbium yag laser + topical sirolimus
Drug: Sirolimus · Other: Erbium yag laser · Device: Pulsed Dye Laser
Pulsed Dye Laser + topical sirolimus
Drug: Sirolimus · Device: Pulsed Dye Laser
Pulsed Dye Laser
Device: Pulsed Dye Laser
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
Er:Yag laser ablation of the stratum corneum
Percentage clearance assessed colorimetrically
Time frame: 10 weeks
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center