Status:
COMPLETED
Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)
Lead Sponsor:
Photocure
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9-35 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlus...
Detailed Description
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Invest...
Eligibility Criteria
Inclusion
- Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).
- Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T1. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.
- Fitzpatrick skin type I through VI.
- Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.
- Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.
- Patients with no more than 2 nodular lesions on the face.
- Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00933543
Start Date
August 1 2009
End Date
March 1 2010
Last Update
December 11 2013
Active Locations (11)
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1
Children's Specialists of San Diego / Rady Children's Hospital San Diego
San Diego, California, United States, 92123
2
DeNova Research
Chicago, Illinois, United States, 60611
3
Dermatology Institute of DuPage Medical Group
Naperville, Illinois, United States, 60563
4
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432