Status:
TERMINATED
Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus
Lead Sponsor:
Erasmus Medical Center
Conditions:
Port-Wine Stain
Eligibility:
All Genders
18+ years
Phase:
NA
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 sirol...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02214706
Start Date
July 1 2014
End Date
December 1 2016
Last Update
February 8 2017
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015CA