N/A
Completed N=27
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Port Wine Stain
Source: ClinicalTrials.gov NCT00585247 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in a* and E at 8 Weeks — 1.27; 0.43; 4.08; 2.59 units on a scale
Summary
Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in a* and E at 8 Weeks |
1.27; 0.43; 4.08; 2.59 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Port Wine Stain birthmark
- Male and female subjects of any age who are in good health.
- Fitzpatrick skin type I-VI
Exclusion Criteria
- Pregnant or lactating
- History of cutaneous photosensitivity
- History of hypersensitivity to imiquimod 5% cream or any of its components
- History of photodermatoses
Data sourced from ClinicalTrials.gov (NCT00585247). 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.