Acne Vulgaris
Conditions
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.
Interventions
Cream application followed by illumination with red light
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| The Proportion of Patients Rated as Clear or Almost Clear at 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. | 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 | immediately after second 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 | immediately after first treatment | — |
| Proportion of Patients With Mild and Moderate Erythema After Second Treatment | immediately after second treatment | — |
| Proportion of Patients With Mild and Moderate Erythema After Third Treatment | immediately after third treatment | — |
| Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment | immediately after fourth treatment | — |
| Proportion of Patients With Severe Erythema After First Treatment | immediately after first treatment | — |
| Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | 3 weeks after last treatment | — |
| Proportion of Patients With Severe Erythema 7 Days After First Treatment | 7 days after first treatment | — |
| Proportion of Patients With Severe Erythema After Second Treatment | immediately after second treatment | — |
| Proportion of Patients With Severe Erythema After Third Treatment | immediately after third treatment | — |
| Proportion of Patients With Severe Erythema After Fourth Treatment | immediately after fourth treatment | — |
| Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 2 days after treatment | — |
| Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 2 weeks after last treatment | — |
| Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 2 days after first treatment | — |
| Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 2 weeks after last treatment | — |
| Proportion of Patients With Severe Erythema 2 Days After First Treatment | 2 days after first 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 | — |
Countries
United States
Participant flow
Recruitment details
First patient entered: February 07, 2007 Last patient last visit (12 week follow-up: July 07, 2008 Last patient last visit (24 week follow-up: September 22, 2008 15 medical derm clinics
Pre-assignment details
Washout periods for prior acne treatment: 14 days for any topical treatment (except medicated cleansers), 1 month for oral antibiotics; 6 months for oral isotretinoin. Patients using birth control pills must have used the same product and dose for at least 6 months and had to agree to stay with the same product and dose for an additional 6 months.
Participants by arm
| Arm | Count |
|---|---|
| 40 mg/g MAL PDT | 50 |
| 80 mg/g MAL PDT | 48 |
| Vehicle PDT | 52 |
| Total | 150 |
Baseline characteristics
| Characteristic | 40 mg/g MAL PDT | 80 mg/g MAL PDT | Vehicle PDT | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 17 Participants | 11 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 31 Participants | 41 Participants | 111 Participants |
| Age Continuous | 21.6 years STANDARD_DEVIATION 5.24 | 20.2 years STANDARD_DEVIATION 4.81 | 22.0 years STANDARD_DEVIATION 5 | 21.3 years STANDARD_DEVIATION 5.05 |
| Fitzpatrick Skin type Fitzpatrick skin type score I | 4 participants | 4 participants | 1 participants | 9 participants |
| Fitzpatrick Skin type Fitzpatrick skin type score II | 11 participants | 11 participants | 15 participants | 37 participants |
| Fitzpatrick Skin type Fitzpatrick skin type score III | 21 participants | 24 participants | 23 participants | 68 participants |
| Fitzpatrick Skin type Fitzpatrick skin type score IV | 14 participants | 9 participants | 13 participants | 36 participants |
| Inflammatory lesion count | 34.2 lesions | 32.1 lesions | 31.2 lesions | 32.5 lesions |
| Investigator's Global Assessment (IGA) Score IGA SCORE 3 (MODERATE ACNE) | 35 participants | 41 participants | 44 participants | 120 participants |
| Investigator's Global Assessment (IGA) Score IGA SCORE 4 (SEVERE ACNE) | 15 participants | 7 participants | 8 participants | 30 participants |
| Non inflammatory lesion count | 39.1 lesions | 35.9 lesions | 35.2 lesions | 36.7 lesions |
| Region of Enrollment United States | 50 participants | 48 participants | 52 participants | 150 participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 36 Participants | 91 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 16 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 50 / 50 | 46 / 48 | 38 / 52 |
| serious Total, serious adverse events | 2 / 50 | 0 / 48 | 0 / 52 |
Outcome results
Primary
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Time frame: 12 weeks after last treatment
Population: ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 40 mg/g MAL PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts | -10.72 lesions |
| 80 mg/g MAL PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts | -9.27 lesions |
| Vehicle PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts | -8.08 lesions |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.323695% CI: [-7.91, 2.63]ANCOVA
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.665795% CI: [-6.64, 4.26]ANCOVA
Primary
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 12 weeks
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 40 mg/g MAL PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -10.95 lesions |
| 80 mg/g MAL PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -11.8 lesions |
| Vehicle PDT | Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -10.62 lesions |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.915195% CI: [-6.53, 5.86]ANCOVA
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.723395% CI: [-7.81, 5.45]ANCOVA
Primary
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
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 16 Percentage of participants |
| 80 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 14.58 Percentage of participants |
| Vehicle PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 11.54 Percentage of participants |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.528895% CI: [-7.97, 19.04]Cochran-Mantel-Haenszel
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.753995% CI: [-8.79, 16.69]Cochran-Mantel-Haenszel
Primary
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
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 17.5 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 21.2 percentage of participants |
| Vehicle PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 16.7 percentage of participants |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.788995% CI: [-11.16, 17.33]Cochran-Mantel-Haenszel
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.88895% CI: [-10.15, 21.11]Cochran-Mantel-Haenszel
Secondary
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time frame: immediately after second treatment
Population: Safety
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 40 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain | 2.0 cm |
| 80 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain | 3.0 cm |
| Vehicle PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain | 0.0 cm |
Secondary
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time frame: immediately after illumination-first treatment
Population: Safety
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 2.05 cm |
| 80 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 2.25 cm |
| Vehicle PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 0.00 cm |
Secondary
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time frame: immediately after illumination-fourth treatment treatment
Population: Safety
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 1.10 cm |
| 80 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 2.50 cm |
| Vehicle PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 0.0 cm |
Secondary
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time frame: immediately after third treatment
Population: Safety
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 1.5 cm |
| 80 mg/g MAL PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 2.0 cm |
| Vehicle PDT | Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. | 0.0 cm |
Secondary
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 3 weeks after last treatment
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -44.5 Percentage change |
| 80 mg/g MAL PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -56.0 Percentage change |
| Vehicle PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -40.5 Percentage change |
Secondary
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -52.0 Percentage change |
| 80 mg/g MAL PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -69.5 Percentage change |
| Vehicle PDT | Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline | -52.0 Percentage change |
Secondary
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline | -38.5 Percentage change |
| 80 mg/g MAL PDT | Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline | -48.0 Percentage change |
| Vehicle PDT | Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline | -38.0 Percentage change |
Secondary
Percent Reduction in Total Lesion Counts From Baseline
Time frame: 6 weeks after last treatment
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 40 mg/g MAL PDT | Percent Reduction in Total Lesion Counts From Baseline | -40 Percentage change |
| 80 mg/g MAL PDT | Percent Reduction in Total Lesion Counts From Baseline | -54 Percentage change |
| Vehicle PDT | Percent Reduction in Total Lesion Counts From Baseline | -37 Percentage change |
Secondary
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time frame: 2 days after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 44.9 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 44.7 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 17.6 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time frame: immediately after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 75.1 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 61.7 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Erythema After First Treatment | 17.6 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Time frame: immediately after fourth treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment | 45.9 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment | 63.1 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment | 15.2 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Time frame: immediately after second treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Second Treatment | 67.4 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Second Treatment | 65.8 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Erythema After Second Treatment | 18.0 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Time frame: immediately after third treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Third Treatment | 67.4 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Erythema After Third Treatment | 71.1 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Erythema After Third Treatment | 16.7 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time frame: 2 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 2.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 10.8 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 5.9 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time frame: 2 days after treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 6.3 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 4.3 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment | 5.9 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 12 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 4.4 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 5.3 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 6.7 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 6 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 6.8 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 8.1 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 9.3 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time frame: 2 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 8.6 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 21.1 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment | 4.4 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time frame: 2 days after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 2.1 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time frame: 2 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 2.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 6 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 2.3 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 2.7 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 2 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 4.4 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 2.2 percentage of participants |
Secondary
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time frame: 12 weeks after last treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 2.2 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Time frame: 2 days after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema 2 Days After First Treatment | 2.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema 2 Days After First Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema 2 Days After First Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Time frame: 7 days after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema 7 Days After First Treatment | 2.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema 7 Days After First Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema 7 Days After First Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema After First Treatment
Time frame: immediately after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema After First Treatment | 0.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema After First Treatment | 2.1 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema After First Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema After Fourth Treatment
Time frame: immediately after fourth treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Fourth Treatment | 0.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Fourth Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema After Fourth Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema After Second Treatment
Time frame: immediately after second treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Second Treatment | 0.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Second Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema After Second Treatment | 0.0 percentage of participants |
Secondary
Proportion of Patients With Severe Erythema After Third Treatment
Time frame: immediately after third treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Third Treatment | 0.0 percentage of participants |
| 80 mg/g MAL PDT | Proportion of Patients With Severe Erythema After Third Treatment | 0.0 percentage of participants |
| Vehicle PDT | Proportion of Patients With Severe Erythema After Third Treatment | 0.0 percentage of participants |
Secondary
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
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 10.5 Precentage of participants |
| 80 mg/g MAL PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 18.8 Precentage of participants |
| Vehicle PDT | Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment | 12.2 Precentage of participants |
Secondary
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Time frame: 12 weeks after last treatment
Population: PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 40 mg/g MAL PDT | The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment | 10.0 percentage of participants |
| 80 mg/g MAL PDT | The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment | 18.2 percentage of participants |
| Vehicle PDT | The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment | 11.9 percentage of participants |