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View Clinical Trial (Medical Research Study)
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Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT) - NCT00933543-92123 (Clinical Trial 300944)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy300944.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92123 |
| Conditions: |
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Acne Vulgaris |
| Purpose: |
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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.
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| Study summary: |
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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 Investigator's Global Assessment (IGA) scale will be included. Each patient will be
classified according to age in the two age groups 9 to 12 years and 13 to 35 years and
randomized to either Visonac or vehicle cream within each age group. All patients will
receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be
done after each treatment and at 12 weeks after the first treatment. Safety evaluations will
be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment
visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment
and at one week after last treatment visit. |
| Criteria: |
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Inclusion Criteria:
- 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 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. |
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| Study is available at: |
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Children's Specialists of San Diego / Rady Children's Hospital San Diego
San Diego, CA 92123
United States
Primary Contact:
Pascale Susi
Email: psusi@rchsd.org
Phone: 858-576-1700
Secondary Contact:
Saeeda Rana, MSc
Email: sr@photocure.no
Phone: +4722061646 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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