Port Wine Stain
Conditions
Keywords
birthmarks
Brief 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.
Detailed description
Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.
Interventions
DRUGImiquimod
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
OTHERPlacebo
Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Sponsors
Beckman Laser Institute University of California Irvine
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in a* and E at 8 Weeks | 8 weeks baseline | Change in a\* and ΔE is a way to quantify PWS treatment outcome: a\* is the erythema of the vascular lesions and varies from +60 for green to -60 for red with a value of +9.28 for Normal Skin. Higher a\* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L\*a\*b\*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imiquimod Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment imiquimod 5% cream for 8 weeks. | 14 |
| Placebo Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks. | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Imiquimod | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment United States | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Change From Baseline in a* and E at 8 Weeks
Change in a\* and ΔE is a way to quantify PWS treatment outcome: a\* is the erythema of the vascular lesions and varies from +60 for green to -60 for red with a value of +9.28 for Normal Skin. Higher a\* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L\*a\*b\*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.
Time frame: 8 weeks baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imiquimod | Change From Baseline in a* and E at 8 Weeks | a* | 1.27 units on a scale | Standard Deviation 1.76 |
| Imiquimod | Change From Baseline in a* and E at 8 Weeks | ΔE | 4.08 units on a scale | Standard Deviation 3.39 |
| Placebo | Change From Baseline in a* and E at 8 Weeks | a* | 0.43 units on a scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline in a* and E at 8 Weeks | ΔE | 2.59 units on a scale | Standard Deviation 1.54 |