Clinical trial NCT00594425: Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
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:

1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
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.

Primary outcomes:
measure: Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
timeFrame: 12 weeks after last treatment
measure: Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
timeFrame: 12 weeks after last treatment
measure: Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
timeFrame: 3 weeks after last treatment
measure: Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
timeFrame: 6 weeks after last treatment
measure: Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
timeFrame: 6 weeks after last treatment
measure: Percent Reduction in Total Lesion Counts From Baseline
timeFrame: 6 weeks after last treatment
measure: Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
timeFrame: 6 weeks after last treatment
measure: The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
timeFrame: 12 weeks after last treatment
measure: Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
timeFrame: immediately after illumination-first treatment
measure: Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
timeFrame: immediately after second treatment
measure: Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
timeFrame: immediately after third treatment
measure: Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
timeFrame: immediately after illumination-fourth treatment treatment
measure: Proportion of Patients With Mild and Moderate Erythema After First Treatment
timeFrame: immediately after first treatment
measure: Proportion of Patients With Mild and Moderate Erythema After First Treatment
timeFrame: 2 days after first treatment
measure: Proportion of Patients With Mild and Moderate Erythema After Second Treatment
timeFrame: immediately after second treatment
measure: Proportion of Patients With Mild and Moderate Erythema After Third Treatment
timeFrame: immediately after third treatment
measure: Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
timeFrame: immediately after fourth treatment
measure: Proportion of Patients With Severe Erythema After First Treatment
timeFrame: immediately after first treatment
measure: Proportion of Patients With Severe Erythema 2 Days After First Treatment
timeFrame: 2 days after first treatment
measure: Proportion of Patients With Severe Erythema 7 Days After First Treatment
timeFrame: 7 days after first treatment
measure: Proportion of Patients With Severe Erythema After Second Treatment
timeFrame: immediately after second treatment
measure: Proportion of Patients With Severe Erythema After Third Treatment
timeFrame: immediately after third treatment
measure: Proportion of Patients With Severe Erythema After Fourth Treatment
timeFrame: immediately after fourth treatment
measure: Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
timeFrame: 2 days after treatment
measure: Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
timeFrame: 2 weeks after first treatment
measure: Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
timeFrame: 2 weeks after last treatment
measure: Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
timeFrame: 6 weeks after last treatment
measure: Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
timeFrame: 12 weeks after last treatment
measure: Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
timeFrame: 2 days after first treatment
measure: Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
timeFrame: 2 weeks after last treatment
measure: Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
timeFrame: 2 weeks after first treatment
measure: Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
timeFrame: 6 weeks after last treatment
measure: Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
timeFrame: 12 weeks after last treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: Clinton Twp
country: United States
facility: Michigan Center for Research Corp
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Dallas
country: United States
facility: Dermatology Treatment & Research
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: The Dermatology Clinical Research Center of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: AAD
name: David Pariser, MD
role: PRINCIPAL_INVESTIGATOR
References: