Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.

Key facts

Study ID

NCT00594425

Run by

Photocure

People needed

150

Starts

2007-02-01

Expected to finish

2008-09-01

Last updated by the study team

2013-08-08

Who can join

Age: 15 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
• Patients with skin type I to IV (Fitzpatrick).
• 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.
• Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
• Patients with no more than 2 nodular lesions on the face.
• 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.
• Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
• Patients must sign the approved informed consent form prior to any study procedures.
• Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

You may not qualify if…

• Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
• Participation in other clinical studies either concurrently or within the last 30 days.
• 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.
• Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
• Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
• 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.
• Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
• Patients with a washout period for oral isotretinoin of less than 6 months.
• Patients with a beard or other facial hair that might interfere with study assessments.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.