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

NCT ID: NCT02214706

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Port-Wine Stain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sirolimus topical 40microgram/cm2

sirolimus topical 40microgram/cm2

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

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

Pulsed Dye Laser + Erbium yag + sirolimus

Pulsed Dye Laser + Erbium yag laser + topical sirolimus

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

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

Erbium yag laser

Intervention Type: OTHER

Er:Yag laser ablation of the stratum corneum

Pulsed Dye Laser

Intervention Type: DEVICE

Pulsed Dye Laser + topical sirolimus

Pulsed Dye Laser + topical sirolimus

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

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

Pulsed Dye Laser

Intervention Type: DEVICE

Pulsed Dye Laser

Pulsed Dye Laser

Group Type: EXPERIMENTAL

Pulsed Dye Laser

Intervention Type: DEVICE

Interventions

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.

Intervention Type: DRUG

Erbium yag laser

Er:Yag laser ablation of the stratum corneum

Intervention Type: OTHER

Pulsed Dye Laser

Intervention Type: DEVICE

Other Intervention Names

Rapamune

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

M.B.A. van Doorn

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martijn van Doorn, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 27320685 (View on PubMed)

Other Identifiers

EMC14022_POLAR

Identifier Type: -

Identifier Source: org_study_id