Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Exclusion Criteria

• •Patients presenting with any of the following will not be included in the study:
• •Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• •Patients unlikely to comply with the protocol, e.g., mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g., drug or alcohol abuse).
• •Female patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.
• •Pregnancy
• •Patients undergoing testosterone or any other systemic hormonal treatment.
• •Patients using hormonal contraceptives solely for the control of acne.
• •Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
• •Patients with porphyria.
• •Patients with cutaneous photosensitivity.
• •Participation in other clinical studies either concurrently or within the last 30 days, before T1.
• •Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T1. Medicated cleansers may be used during the washout period and stopped before the treatment.
• •Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T1.
• •Patients with a washout period for oral isotretinoin of less than 6 months, before T1.
• •Patients with a beard or other facial hair that might interfere with study assessments.
• •Patients with melanoma or dysplastic nevi in the treatment area.
• •Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
• •Exposure to PDT within 12 weeks before T1.