Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
1 other identifier
interventional
150
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2007
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
August 8, 2013
CompletedAugust 8, 2013
August 1, 2013
1.4 years
January 3, 2008
March 14, 2013
August 7, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
12 weeks
Secondary Outcomes (31)
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
3 weeks after last treatment
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
6 weeks after last treatment
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
6 weeks after last treatment
Percent Reduction in Total Lesion Counts From Baseline
6 weeks after last treatment
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
6 weeks after last treatment
- +26 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALPDT using MAL concentration A
2
EXPERIMENTALPDT using MAL concentration B
3
PLACEBO COMPARATORPDT using Placebo cream
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Photocurelead
Study Sites (14)
Therapeutics Clinical Research
San Diego, California, 92123, United States
Solano Clinical Research
Vallejo, California, 94589, United States
DuPage Medical Group
Naperville, Illinois, 60563, United States
Michigan Center for Research Corp
Clinton Twp, Michigan, 48038, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Dermatology Associates of Rochester
Rochester, New York, 14623, United States
Central Sooner Research
Norman, Oklahoma, 73069, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology Treatment & Research
Dallas, Texas, 75230, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501-1604, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Pariser MD
- Organization
- Virginia Clinical Research, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
David Pariser, MD
AAD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 15, 2008
Study Start
February 1, 2007
Primary Completion
July 1, 2008
Study Completion
September 1, 2008
Last Updated
August 8, 2013
Results First Posted
August 8, 2013
Record last verified: 2013-08