N/A
Completed N=22
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Port-Wine Stain
Source: ClinicalTrials.gov NCT01775722 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Percent Change in Blanching of Port Wine Stain — 6; 5 percentage
Summary
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Blanching of Port Wine Stain |
6; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Port Wine Stain suitable for comparison testing
- Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
- Apparent good health as documented by medical history
- Ability to understand and carry out subject instructions
Exclusion Criteria
- History of photodermatoses or skin cancer
- Any therapy within the previous two months to the proposed port wine stain treatment sites
- Current participation in any other investigational drug or device evaluation
- Concurrent use of known photosensitizing drugs
- Inability to understand and carry out instructions
Data sourced from ClinicalTrials.gov (NCT01775722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.