Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
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ClinicalTrials.gov Identifier: NCT00594425 |
Recruitment Status :
Completed
First Posted : January 15, 2008
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: Methyl aminolevulinate (MAL) PDT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
PDT using MAL concentration A
|
Drug: Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light |
Experimental: 2
PDT using MAL concentration B
|
Drug: Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light |
Placebo Comparator: 3
PDT using Placebo cream
|
Drug: Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light |
- 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 ]
- Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts [ Time Frame: 12 weeks after last treatment ]
- Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 12 weeks ]
- Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 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 ]
- Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
- Percent Reduction in Total Lesion Counts From Baseline [ Time Frame: 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 ]
- The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment [ Time Frame: 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
- 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
- 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
- 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
- Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: immediately after first treatment ]
- Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: 2 days after first treatment ]
- Proportion of Patients With Mild and Moderate Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
- Proportion of Patients With Mild and Moderate Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
- Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
- Proportion of Patients With Severe Erythema After First Treatment [ Time Frame: immediately after first treatment ]
- Proportion of Patients With Severe Erythema 2 Days After First Treatment [ Time Frame: 2 days after first treatment ]
- Proportion of Patients With Severe Erythema 7 Days After First Treatment [ Time Frame: 7 days after first treatment ]
- Proportion of Patients With Severe Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
- Proportion of Patients With Severe Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
- Proportion of Patients With Severe Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
- Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 days after treatment ]
- Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
- Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
- Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
- Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]
- Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 days after first treatment ]
- Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
- Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
- Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
- Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594425
United States, California | |
Therapeutics Clinical Research | |
San Diego, California, United States, 92123 | |
Solano Clinical Research | |
Vallejo, California, United States, 94589 | |
United States, Illinois | |
DuPage Medical Group | |
Naperville, Illinois, United States, 60563 | |
United States, Michigan | |
Michigan Center for Research Corp | |
Clinton Twp, Michigan, United States, 48038 | |
United States, New Mexico | |
Academic Dermatology Associates | |
Albuquerque, New Mexico, United States, 87106 | |
United States, New York | |
Dermatology Associates of Rochester | |
Rochester, New York, United States, 14623 | |
United States, Oklahoma | |
Central Sooner Research | |
Norman, Oklahoma, United States, 73069 | |
United States, Oregon | |
Oregon Dermatology and Research Center | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
Dermatology Treatment & Research | |
Dallas, Texas, United States, 75230 | |
Suzanne Bruce and Associates, PA | |
Houston, Texas, United States, 77056 | |
The Dermatology Clinical Research Center of San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Dermatology Research Center, Inc. | |
Salt Lake City, Utah, United States, 84124 | |
United States, Virginia | |
The Education & Research Foundation, Inc. | |
Lynchburg, Virginia, United States, 24501-1604 | |
Virginia Clinical Research, Inc. | |
Norfolk, Virginia, United States, 23507 |
Principal Investigator: | David Pariser, MD | AAD |
Responsible Party: | Photocure |
ClinicalTrials.gov Identifier: | NCT00594425 |
Other Study ID Numbers: |
PC TA202B/06 |
First Posted: | January 15, 2008 Key Record Dates |
Results First Posted: | August 8, 2013 |
Last Update Posted: | August 8, 2013 |
Last Verified: | August 2013 |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |
Aminolevulinic Acid Methyl 5-aminolevulinate Photosensitizing Agents Dermatologic Agents |