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Trial record 22 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

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

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ClinicalTrials.gov Identifier: NCT02214706
Recruitment Status : Terminated (Lack of efficacy / adverse events)
First Posted : August 12, 2014
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
M.B.A. van Doorn, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Port-Wine Stain Drug: Sirolimus Other: Erbium yag laser Device: Pulsed Dye Laser Not Applicable

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  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: sirolimus topical 40microgram/cm2
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 Name: 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 Name: Rapamune

Other: Erbium yag laser
Er:Yag laser ablation of the stratum corneum

Device: Pulsed Dye Laser
Experimental: Pulsed Dye Laser + topical sirolimus
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 Name: Rapamune

Device: Pulsed Dye Laser
Experimental: Pulsed Dye Laser
Pulsed Dye Laser
Device: Pulsed Dye Laser



Primary Outcome Measures :
  1. Percentage clearance assessed colorimetrically [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214706


Locations
Netherlands
Erasmus MC
Rotterdam, Zuid-Holland, Netherlands, 3015CA
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Martijn van Doorn, MD, Phd Erasmus MC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.B.A. van Doorn, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02214706     History of Changes
Other Study ID Numbers: EMC14022_POLAR
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Port-Wine Stain
Vascular Malformations
Hemangioma, Capillary
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs