Trial Outcomes & Findings for Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne (NCT NCT00594425)
NCT ID: NCT00594425
Last Updated: 2013-08-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
12 weeks after last treatment
Results posted on
2013-08-08
Participant Flow
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
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.
Participant milestones
| Measure |
40 mg/g MAL PDT
|
80 mg/g MAL PDT
|
Vehicle PDT
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
52
|
|
Overall Study
COMPLETED
|
43
|
34
|
42
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Baseline characteristics by cohort
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
21.6 years
STANDARD_DEVIATION 5.24 • n=5 Participants
|
20.2 years
STANDARD_DEVIATION 4.81 • n=7 Participants
|
22.0 years
STANDARD_DEVIATION 5.00 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 5.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
52 participants
n=5 Participants
|
150 participants
n=4 Participants
|
|
Inflammatory lesion count
|
34.2 lesions
n=5 Participants
|
32.1 lesions
n=7 Participants
|
31.2 lesions
n=5 Participants
|
32.5 lesions
n=4 Participants
|
|
Non inflammatory lesion count
|
39.1 lesions
n=5 Participants
|
35.9 lesions
n=7 Participants
|
35.2 lesions
n=5 Participants
|
36.7 lesions
n=4 Participants
|
|
Investigator's Global Assessment (IGA) Score
IGA SCORE 3 (MODERATE ACNE)
|
35 participants
n=5 Participants
|
41 participants
n=7 Participants
|
44 participants
n=5 Participants
|
120 participants
n=4 Participants
|
|
Investigator's Global Assessment (IGA) Score
IGA SCORE 4 (SEVERE ACNE)
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Fitzpatrick Skin type
Fitzpatrick skin type score I
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Fitzpatrick Skin type
Fitzpatrick skin type score II
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Fitzpatrick Skin type
Fitzpatrick skin type score III
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
23 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Fitzpatrick Skin type
Fitzpatrick skin type score IV
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last treatmentPopulation: ITT population
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
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
Interval 8.34 to 28.51
|
14.58 Percentage of participants
Interval 7.25 to 27.17
|
11.54 Percentage of participants
Interval 5.4 to 22.97
|
PRIMARY outcome
Timeframe: 12 weeks after last treatmentPopulation: ITT population
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
|
-10.72 lesions
Interval -14.45 to -6.99
|
-9.27 lesions
Interval -13.25 to -5.3
|
-8.08 lesions
Interval -11.8 to -4.6
|
PRIMARY outcome
Timeframe: 12 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=42 Participants
|
80 mg/g MAL PDT
n=40 Participants
|
Vehicle PDT
n=33 Participants
|
|---|---|---|---|
|
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
Interval 6.72 to 27.84
|
21.2 percentage of participants
Interval 8.75 to 31.95
|
16.7 percentage of participants
Interval 10.68 to 37.75
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=42 Participants
|
80 mg/g MAL PDT
n=40 Participants
|
Vehicle PDT
n=33 Participants
|
|---|---|---|---|
|
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
|
-10.95 lesions
Interval -15.18 to -6.72
|
-11.8 lesions
Interval -16.65 to -6.95
|
-10.62 lesions
Interval -15.12 to -6.12
|
SECONDARY outcome
Timeframe: 3 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=40 Participants
|
80 mg/g MAL PDT
n=33 Participants
|
Vehicle PDT
n=42 Participants
|
|---|---|---|---|
|
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
|
-44.5 Percentage change
Full Range 39,32 • Interval -89.0 to 42.0
|
-56.0 Percentage change
Full Range 44-34 • Interval -95.0 to 44.0
|
-40.5 Percentage change
Full Range 34-41 • Interval -100.0 to 71.0
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=40 Participants
|
80 mg/g MAL PDT
n=33 Participants
|
Vehicle PDT
n=42 Participants
|
|---|---|---|---|
|
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
|
-52.0 Percentage change
Interval -92.0 to 88.0
|
-69.5 Percentage change
Interval -95.0 to 45.0
|
-52.0 Percentage change
Interval -96.0 to 71.0
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=40 Participants
|
80 mg/g MAL PDT
n=33 Participants
|
Vehicle PDT
n=42 Participants
|
|---|---|---|---|
|
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
|
-38.5 Percentage change
Interval -89.0 to 160.0
|
-48.0 Percentage change
Interval -95.0 to 104.0
|
-38.0 Percentage change
Interval -100.0 to 225.0
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=38 Participants
|
80 mg/g MAL PDT
n=32 Participants
|
Vehicle PDT
n=41 Participants
|
|---|---|---|---|
|
Percent Reduction in Total Lesion Counts From Baseline
|
-40 Percentage change
Interval -88.0 to 66.0
|
-54 Percentage change
Interval -87.0 to 68.0
|
-37 Percentage change
Interval -94.0 to 100.0
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=42 Participants
|
80 mg/g MAL PDT
n=40 Participants
|
Vehicle PDT
n=33 Participants
|
|---|---|---|---|
|
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
|
18.8 Precentage of participants
|
12.2 Precentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last treatmentPopulation: 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).
Outcome measures
| Measure |
40 mg/g MAL PDT
n=40 Participants
|
80 mg/g MAL PDT
n=33 Participants
|
Vehicle PDT
n=42 Participants
|
|---|---|---|---|
|
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
|
10.0 percentage of participants
|
18.2 percentage of participants
|
11.9 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after illumination-first treatmentPopulation: Safety
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
|
2.05 cm
Interval 0.0 to 10.0
|
2.25 cm
Interval 0.0 to 9.0
|
0.00 cm
Interval 0.0 to 3.5
|
SECONDARY outcome
Timeframe: immediately after second treatmentPopulation: Safety
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=41 Participants
|
Vehicle PDT
n=50 Participants
|
|---|---|---|---|
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
|
2.0 cm
Interval 0.0 to 7.5
|
3.0 cm
Interval 0.0 to 8.0
|
0.0 cm
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: immediately after third treatmentPopulation: Safety
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=48 Participants
|
|---|---|---|---|
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
|
1.5 cm
Interval 0.0 to 8.0
|
2.0 cm
Interval 0.0 to 6.0
|
0.0 cm
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: immediately after illumination-fourth treatment treatmentPopulation: Safety
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Outcome measures
| Measure |
40 mg/g MAL PDT
n=45 Participants
|
80 mg/g MAL PDT
n=37 Participants
|
Vehicle PDT
n=46 Participants
|
|---|---|---|---|
|
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
|
1.10 cm
Interval 0.0 to 6.4
|
2.50 cm
Interval 0.0 to 7.0
|
0.0 cm
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: immediately after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Erythema After First Treatment
|
75.1 percentage of participants
|
61.7 percentage of participants
|
17.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 days after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Erythema After First Treatment
|
44.9 percentage of participants
|
44.7 percentage of participants
|
17.6 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after second treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
|
67.4 percentage of participants
|
65.8 percentage of participants
|
18.0 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after third treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
|
67.4 percentage of participants
|
71.1 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after fourth treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=54 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
|
45.9 percentage of participants
|
63.1 percentage of participants
|
15.2 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=48 Participants
|
Vehicle PDT
n=52 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema After First Treatment
|
0.0 percentage of participants
|
2.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 days after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=49 Participants
|
80 mg/g MAL PDT
n=47 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema 2 Days After First Treatment
|
2.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 7 days after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=50 Participants
|
80 mg/g MAL PDT
n=46 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema 7 Days After First Treatment
|
2.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after second treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=41 Participants
|
Vehicle PDT
n=50 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema After Second Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after third treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=48 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema After Third Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: immediately after fourth treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=45 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=46 Participants
|
|---|---|---|---|
|
Proportion of Patients With Severe Erythema After Fourth Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 days after treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=48 Participants
|
80 mg/g MAL PDT
n=47 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
|
6.3 percentage of participants
|
4.3 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=49 Participants
|
80 mg/g MAL PDT
n=46 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
|
2.0 percentage of participants
|
10.8 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=45 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
|
8.6 percentage of participants
|
21.1 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=44 Participants
|
80 mg/g MAL PDT
n=37 Participants
|
Vehicle PDT
n=43 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
|
6.8 percentage of participants
|
8.1 percentage of participants
|
9.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=45 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=45 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
|
4.4 percentage of participants
|
5.3 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: 2 days after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=48 Participants
|
80 mg/g MAL PDT
n=47 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
|
2.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=46 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=45 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
|
4.4 percentage of participants
|
0.0 percentage of participants
|
2.2 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after first treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=49 Participants
|
80 mg/g MAL PDT
n=46 Participants
|
Vehicle PDT
n=51 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
|
2.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=44 Participants
|
80 mg/g MAL PDT
n=37 Participants
|
Vehicle PDT
n=43 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
|
2.3 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after last treatmentPopulation: Safety
Outcome measures
| Measure |
40 mg/g MAL PDT
n=45 Participants
|
80 mg/g MAL PDT
n=38 Participants
|
Vehicle PDT
n=45 Participants
|
|---|---|---|---|
|
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
|
2.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
40 mg/g MAL PDT
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
80 mg/g MAL PDT
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Vehicle PDT
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40 mg/g MAL PDT
n=50 participants at risk
|
80 mg/g MAL PDT
n=48 participants at risk
|
Vehicle PDT
n=52 participants at risk
|
|---|---|---|---|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
2.0%
1/50
|
0.00%
0/48
|
0.00%
0/52
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
2.0%
1/50
|
0.00%
0/48
|
0.00%
0/52
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
2.0%
1/50
|
0.00%
0/48
|
0.00%
0/52
|
Other adverse events
| Measure |
40 mg/g MAL PDT
n=50 participants at risk
|
80 mg/g MAL PDT
n=48 participants at risk
|
Vehicle PDT
n=52 participants at risk
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE DISCOLOURATION
|
6.0%
3/50
|
14.6%
7/48
|
5.8%
3/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE DRYNESS
|
2.0%
1/50
|
6.2%
3/48
|
0.00%
0/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE ERYTHEMA
|
80.0%
40/50
|
72.9%
35/48
|
32.7%
17/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE EXFOLIATION
|
6.0%
3/50
|
6.2%
3/48
|
0.00%
0/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE IRRITATION
|
62.0%
31/50
|
54.2%
26/48
|
7.7%
4/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE PAIN
|
64.0%
32/50
|
64.6%
31/48
|
9.6%
5/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE PARAESTHESIA
|
6.0%
3/50
|
18.8%
9/48
|
7.7%
4/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE PRURITUS
|
26.0%
13/50
|
20.8%
10/48
|
9.6%
5/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE SCAB
|
6.0%
3/50
|
6.2%
3/48
|
0.00%
0/52
|
|
Skin and subcutaneous tissue disorders
APPLICATION SITE WARMTH
|
4.0%
2/50
|
0.00%
0/48
|
7.7%
4/52
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/50
|
2.1%
1/48
|
7.7%
4/52
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.0%
3/50
|
2.1%
1/48
|
1.9%
1/52
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/50
|
6.2%
3/48
|
1.9%
1/52
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/50
|
8.3%
4/48
|
7.7%
4/52
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
18.0%
9/50
|
6.2%
3/48
|
17.3%
9/52
|
|
Nervous system disorders
Headache
|
4.0%
2/50
|
4.2%
2/48
|
0.00%
0/52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data from the study are free for publication. However if publication of the results may endanger adequate patent protection for new principles,compounds,or formulations,Photocure has the right to decide when the results are free to be published. Before this agreed time, no data from the trial will be published, presented, or communicated, except to regulatory authorities and ethics committees. Both the investigators and Photocure will be given 30 days to review and comment.
- Publication restrictions are in place
Restriction type: OTHER