Abstract | BACKGROUND AND OBJECTIVE: STUDY DESIGN/MATERIALS AND METHODS: This pilot study involved a retrospective review of 20 subjects, all Asian, with PWS. Subject ages ranged between 3 and 56 years. Upon enrollment, three test sites were prospectively identified on each subject for treatment assignments to the following regimens: (A) PDL+Imiquimod; (B) PDL alone; and (C) Imiquimod alone. PDL test sites received a single treatment with a 585 nm wavelength; 1.5 milliseconds pulse duration; spot size 7 mm using a light dosage of 10 J/cm2 with cryogen spray cooling. For the PDL+Imiquimod and Imiquimod alone test sites, subjects were instructed to apply Imiquimod topically to the sites once daily for 1 month after PDL exposure. Subjects were followed-up at 1, 3, 6, and 12 months after PDL exposure to evaluate each of the three test sites. The primary efficacy measurement was the quantitative assessment of blanching responses as measured by a DermoSpectrometer to calculate the hemoglobin-index of each site at 1, 3, 6, and 12 months after PDL exposure. Subjects were also closely monitored for any adverse effects. RESULTS: Based on paired sample test analysis, there were clinically, and statistically significant, differences in blanching responses over time favoring PWS receiving PDL+Imiquimod as compared to either PDL or Imiquimod alone (P<0.05). At 12 months, it should be noted that there was some evidence of redarkening of PWS test sites treated by PDL+Imiquimod and PDL alone, presumably due to revascularization of blood vessels. However, based on comparison of the hemoglobin-indices determined at 1 and 12 months after PDL exposure, there was less revascularization of PWS test sites treated with PDL+Imiquimod as compared to PDL alone (P<0.05). Transient hyperpigmentation was noted in 10% (n = 2) and 40% (n = 8) of subjects on the PDL+Imiquimod and PDL alone test sites, respectively. On all sites, hyperpigmentation resolved spontaneously without medical intervention within 6 months. Permanent hypopigmentation or scarring was not observed on any test site. CONCLUSION: Based on the results of this pilot study, PDL+Imiquimod resulted in superior blanching responses over time as compared to PDL alone for treatment of test sites on PWS lesions. Although the PDL+Imiquimod approach is intriguing, clinical validation in large PWS patient samples is required.
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Authors | Cheng-Jen Chang, Yen-Chang Hsiao, Martin C Mihm Jr, J Stuart Nelson |
Journal | Lasers in surgery and medicine
(Lasers Surg Med)
Vol. 40
Issue 9
Pg. 605-10
(Nov 2008)
ISSN: 1096-9101 [Electronic] United States |
PMID | 18951427
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | (c) 2008 Wiley-Liss, Inc. |
Chemical References |
- Aminoquinolines
- Interferon Inducers
- Imiquimod
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Topics |
- Administration, Cutaneous
- Adolescent
- Adult
- Aminoquinolines
(administration & dosage)
- Child
- Child, Preschool
- Cohort Studies
- Combined Modality Therapy
- Female
- Humans
- Imiquimod
- Interferon Inducers
(administration & dosage)
- Laser Therapy
- Lasers, Dye
(therapeutic use)
- Male
- Middle Aged
- Pilot Projects
- Port-Wine Stain
(drug therapy, pathology, surgery)
- Retrospective Studies
- Treatment Outcome
- Young Adult
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