Phase 2
N=150
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00594425 ↗Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Aug 2013
Primary outcome: Primary: Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment — 16; 14.58; 11.54 Percentage of participants — p=0.5288
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methyl aminolevulinate (MAL) PDT (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Photocure
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment |
17.5; 21.2; 16.7 | 0.7889 |
| PRIMARY Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts |
-10.72; -9.27; -8.08 | 0.3236 |
| PRIMARY Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline |
-10.95; -11.8; -10.62 | 0.9151 |
| SECONDARY Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline |
-52.0; -69.5; -52.0 | — |
| SECONDARY Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline |
-52.0; -69.5; -52.0 | — |
| SECONDARY Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline |
-38.5; -48.0; -38.0 | — |
| SECONDARY Percent Reduction in Total Lesion Counts From Baseline |
-40; -54; -37 | — |
| SECONDARY Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment |
17.5; 21.2; 16.7 | 0.7889 |
| SECONDARY The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment |
10.0; 18.2; 11.9 | — |
| SECONDARY Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. |
1.10; 2.50; 0.0 | — |
| SECONDARY Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain |
2.0; 3.0; 0.0 | — |
| SECONDARY Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. |
1.10; 2.50; 0.0 | — |
| SECONDARY Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. |
1.10; 2.50; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Erythema After First Treatment |
44.9; 44.7; 17.6 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Erythema After First Treatment |
44.9; 44.7; 17.6 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Erythema After Second Treatment |
67.4; 65.8; 18.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Erythema After Third Treatment |
67.4; 71.1; 16.7 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment |
45.9; 63.1; 15.2 | — |
| SECONDARY Proportion of Patients With Severe Erythema After First Treatment |
0.0; 2.1; 0.0 | — |
| SECONDARY Proportion of Patients With Severe Erythema 2 Days After First Treatment |
2.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Severe Erythema 7 Days After First Treatment |
2.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Severe Erythema After Second Treatment |
0.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Severe Erythema After Third Treatment |
0.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Severe Erythema After Fourth Treatment |
0.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment |
2.0; 10.8; 5.9 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment |
2.0; 10.8; 5.9 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment |
4.4; 5.3; 6.7 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment |
4.4; 5.3; 6.7 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment |
4.4; 5.3; 6.7 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment |
2.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment |
2.2; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment |
2.0; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment |
2.2; 0.0; 0.0 | — |
| SECONDARY Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment |
2.2; 0.0; 0.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00594425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.