Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
NCT ID: NCT00594425
Last Updated: 2013-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2007-02-28
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PDT using MAL concentration A
Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
2
PDT using MAL concentration B
Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
3
PDT using Placebo cream
Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
Interventions
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Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
Eligibility Criteria
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Inclusion Criteria
2. Patients with skin type I to IV (Fitzpatrick).
3. Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
4. Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
5. Patients with no more than 2 nodular lesions on the face.
6. Patients who are surgically sterile, 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 Day 0. 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.
7. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
8. Patients must sign the approved informed consent form prior to any study procedures.
9. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.
Exclusion Criteria
2. Participation in other clinical studies either concurrently or within the last 30 days.
3. Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
5. Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
6. Patients with a washout period for topical treatments for their acne of less than 14 days. Medicated cleansers may be used during the washout period and stopped before the treatment.
7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
8. Patients with a washout period for oral isotretinoin of less than 6 months.
9. Patients with a beard or other facial hair that might interfere with study assessments.
15 Years
40 Years
ALL
No
Sponsors
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Photocure
INDUSTRY
Responsible Party
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Principal Investigators
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David Pariser, MD
Role: PRINCIPAL_INVESTIGATOR
AAD
Locations
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Therapeutics Clinical Research
San Diego, California, United States
Solano Clinical Research
Vallejo, California, United States
DuPage Medical Group
Naperville, Illinois, United States
Michigan Center for Research Corp
Clinton Twp, Michigan, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Associates of Rochester
Rochester, New York, United States
Central Sooner Research
Norman, Oklahoma, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Dermatology Treatment & Research
Dallas, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Other Identifiers
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PC TA202B/06
Identifier Type: -
Identifier Source: org_study_id