A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT

Exclusion Criteria

• •1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
• •2. Subject has plaque/nodular changes and severe hypertrophy within the target PWB area.
• •3. Subject has Sturge-Weber syndrome.
• •4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.
• •5. The subject has evidence of scarring within the target PWB area and/or the subject has a history of hypertrophic scarring or keloidal scarring.
• •6. Subject is immunosuppressed related to medication use and/or disease.
• •7. The subject has clinical abnormalities, as determined by the Investigator, which makes them unsuitable for receiving study treatment in the Investigator's opinion at Screening.
• •8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.
• •9. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity).
• •10. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study.
• •11. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation.
• •12. The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis.
• •13. The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.