- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00594425
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
August 7, 2013 updated by: Photocure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2.
One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively.
The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Therapeutics Clinical Research
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Vallejo, California, United States, 94589
- Solano Clinical Research
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-
Illinois
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Naperville, Illinois, United States, 60563
- DuPage Medical Group
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-
Michigan
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Clinton Twp, Michigan, United States, 48038
- Michigan Center for Research Corp
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-
New Mexico
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Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
-
-
New York
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Rochester, New York, United States, 14623
- Dermatology Associates of Rochester
-
-
Oklahoma
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Norman, Oklahoma, United States, 73069
- Central Sooner Research
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-
Oregon
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Portland, Oregon, United States, 97210
- Oregon Dermatology and Research Center
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-
Texas
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Dallas, Texas, United States, 75230
- Dermatology Treatment & Research
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Houston, Texas, United States, 77056
- Suzanne Bruce and Associates, PA
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San Antonio, Texas, United States, 78229
- The Dermatology Clinical Research Center of San Antonio
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-
Utah
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Salt Lake City, Utah, United States, 84124
- Dermatology Research Center, Inc.
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Virginia
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Lynchburg, Virginia, United States, 24501-1604
- The Education & Research Foundation, Inc.
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Norfolk, Virginia, United States, 23507
- Virginia Clinical Research, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
PDT using MAL concentration A
|
Cream application followed by illumination with red light
|
Experimental: 2
PDT using MAL concentration B
|
Cream application followed by illumination with red light
|
Placebo Comparator: 3
PDT using Placebo cream
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Cream application followed by illumination with red light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Time Frame: 12 weeks after last treatment
|
12 weeks after last treatment
|
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Time Frame: 12 weeks after last treatment
|
12 weeks after last treatment
|
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame: 3 weeks after last treatment
|
3 weeks after last treatment
|
|
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame: 6 weeks after last treatment
|
6 weeks after last treatment
|
|
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Time Frame: 6 weeks after last treatment
|
6 weeks after last treatment
|
|
Percent Reduction in Total Lesion Counts From Baseline
Time Frame: 6 weeks after last treatment
|
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
Time Frame: 6 weeks after last treatment
|
6 weeks after last treatment
|
|
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Time Frame: 12 weeks after last treatment
|
12 weeks after last treatment
|
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time Frame: immediately after illumination-first treatment
|
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
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immediately after illumination-first treatment
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Time Frame: immediately after second treatment
|
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
|
immediately after second treatment
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time Frame: immediately after third treatment
|
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
|
immediately after third treatment
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Time Frame: immediately after illumination-fourth treatment treatment
|
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
|
immediately after illumination-fourth treatment treatment
|
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time Frame: immediately after first treatment
|
immediately after first treatment
|
|
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time Frame: 2 days after first treatment
|
2 days after first treatment
|
|
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Time Frame: immediately after second treatment
|
immediately after second treatment
|
|
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Time Frame: immediately after third treatment
|
immediately after third treatment
|
|
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Time Frame: immediately after fourth treatment
|
immediately after fourth treatment
|
|
Proportion of Patients With Severe Erythema After First Treatment
Time Frame: immediately after first treatment
|
immediately after first treatment
|
|
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Time Frame: 2 days after first treatment
|
2 days after first treatment
|
|
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Time Frame: 7 days after first treatment
|
7 days after first treatment
|
|
Proportion of Patients With Severe Erythema After Second Treatment
Time Frame: immediately after second treatment
|
immediately after second treatment
|
|
Proportion of Patients With Severe Erythema After Third Treatment
Time Frame: immediately after third treatment
|
immediately after third treatment
|
|
Proportion of Patients With Severe Erythema After Fourth Treatment
Time Frame: immediately after fourth treatment
|
immediately after fourth treatment
|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time Frame: 2 days after treatment
|
2 days after treatment
|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time Frame: 2 weeks after first treatment
|
2 weeks after first treatment
|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame: 2 weeks after last treatment
|
2 weeks after last treatment
|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame: 6 weeks after last treatment
|
6 weeks after last treatment
|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame: 12 weeks after last treatment
|
12 weeks after last treatment
|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time Frame: 2 days after first treatment
|
2 days after first treatment
|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame: 2 weeks after last treatment
|
2 weeks after last treatment
|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time Frame: 2 weeks after first treatment
|
2 weeks after first treatment
|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame: 6 weeks after last treatment
|
6 weeks after last treatment
|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame: 12 weeks after last treatment
|
12 weeks after last treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Pariser, MD, AAD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
August 8, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC TA202B/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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