Trial Outcomes & Findings for Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT (NCT NCT02878382)
NCT ID: NCT02878382
Last Updated: 2020-08-04
Results Overview
To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp. The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention. Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side.
COMPLETED
NA
20 participants
Change from baseline, 90 days, 180 days and 12 months after the PDT
2020-08-04
Participant Flow
All twenty patients completed the 12 -month study. Patients were male, Fitzpatrick skin types I-III and mean age 73.8 years (range 54-89).
Unit of analysis: half scalp
Participant milestones
| Measure |
Calcipotriol Assisted MAL-PDT
Calcipotriol + MAL-PDT half scalp
|
Conventional MAL-PDT
MAL-PDT alone half scalp
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
20 20
|
20 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.
Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=99 Participants
|
|
number of AKs at baseline
CAL-PDT side
|
290 number of lesions
n=99 Participants
|
|
number of AKs at baseline
Conventional PDT
|
284 number of lesions
n=99 Participants
|
|
number of AKs at baseline
CAL-PDT side grade I
|
223 number of lesions
n=99 Participants
|
|
number of AKs at baseline
CAL-PDT side grade II
|
67 number of lesions
n=99 Participants
|
|
number of AKs at baseline
Conventional PDT grade I
|
222 number of lesions
n=99 Participants
|
|
number of AKs at baseline
Conventional PDT grade II
|
62 number of lesions
n=99 Participants
|
PRIMARY outcome
Timeframe: Change from baseline, 90 days, 180 days and 12 months after the PDTTo compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp. The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention. Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side.
Outcome measures
| Measure |
Calcipotriol Assisted MAL-PDT
n=20 Participants
Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
Conventional MAL-PDT
n=20 Participants
intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
|---|---|---|
|
Changes From Baseline in Actinic Keratosis - Lesion Base Count.
3 months outcome
|
1.15 lesions
Standard Deviation 0.99
|
2.65 lesions
Standard Deviation 1.35
|
|
Changes From Baseline in Actinic Keratosis - Lesion Base Count.
6 months outcome
|
1.15 lesions
Standard Deviation 0.93
|
2.60 lesions
Standard Deviation 1.14
|
|
Changes From Baseline in Actinic Keratosis - Lesion Base Count.
12 months outcome
|
1.35 lesions
Standard Deviation 1.04
|
3.20 lesions
Standard Deviation 1.44
|
PRIMARY outcome
Timeframe: Change from baseline, 90 days, 6 months and 12 months after PDTAK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention. At baseline: 290 on the CAL-PDT side and 284 on the conventional side.
Outcome measures
| Measure |
Calcipotriol Assisted MAL-PDT
n=20 Participants
Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
Conventional MAL-PDT
n=20 Participants
intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
|---|---|---|
|
Percentage of Actinic Keratosis (AK) Lesions Cleared
3 months outcome
|
92.1 percentage of lesions cleared
|
82 percentage of lesions cleared
|
|
Percentage of Actinic Keratosis (AK) Lesions Cleared
6 months outcome
|
92.1 percentage of lesions cleared
|
81.7 percentage of lesions cleared
|
|
Percentage of Actinic Keratosis (AK) Lesions Cleared
12 months outcome
|
90.7 percentage of lesions cleared
|
77.5 percentage of lesions cleared
|
SECONDARY outcome
Timeframe: immediately after interventionMeasurement of pain during LED illumination and comparison between the sides with a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain. At baseline, before the illumination, there is an absence of pain, which means Score 0 (zero) for all participants before the procedure. Pain is reffered during and after the illumination and measured with the VAS scale, reported by each patient.
Outcome measures
| Measure |
Calcipotriol Assisted MAL-PDT
n=20 Participants
Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
Conventional MAL-PDT
n=20 Participants
intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
|---|---|---|
|
Pain Scores Immediately Post Illumination
|
5.4 units on a scale
Standard Deviation 1.4
|
4.0 units on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes after illuminationMeasurement of PPIX fluorescence on both sides of the scalp before and immediately after LED illumination PpIX fluorescence was measured in three different spot areas on the scalp before and immediately after PDT on each side. The measurements were taken noninvasively in the areas where PpIX fluorescence was more intense, with a handheld fluorescence photometer (USB 2000+ spectroscopy device; Ocean Optics, Dunedin, FL, U.S.A.). The photometer illuminates a circular skin area with a diameter of 1 cm with blue light (400-420 nm), matching the Soret band of PpIX at 405-420 nm. By measuring excitation wavelengths at 600- 700 nm, the corresponding red PpIX fluorescence intensity at 633 nm is detected. Measurements were taken in arbitrary units. The mean PpIX fluorescence value for each side was calculated before and after the treatment.
Outcome measures
| Measure |
Calcipotriol Assisted MAL-PDT
n=20 Participants
Calcipotriol 15 days before - once a day intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
Conventional MAL-PDT
n=20 Participants
intervention: MAL-PDT plus curettage Illumination LED 635 nm 37J/cm2
|
|---|---|---|
|
Change From Baseline in Fluorescence Intensity of PPIX
|
3422.85 arbitrary units
Standard Deviation 1775.19
|
2688.35 arbitrary units
Standard Deviation 1746.12
|
Adverse Events
Calcipotriol Assisted MAL-PDT
Conventional MAL-PDT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcipotriol Assisted MAL-PDT
n=20 participants at risk
Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT
Calcipotriol assisted MAL-PDT: Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
|
Conventional MAL-PDT
n=20 participants at risk
Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs.
Conventional MAL-PDT: Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
local skin reactions
|
75.0%
15/20 • Number of events 22 • side effects collected over 10 days
During light exposure patients were asked to evaluate the intensity of pain using a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain. Local skin reactions (erythema, edema, pustules, crusts, erosions and ulcerations) were recorded as well as any systemic adverse events during treatment and after follow-up visits. Clinical assessments of the local skin reactions were performed on a pre-defined scale as: 0 = no reaction, + mild, ++ moderate, +++ severe
|
60.0%
12/20 • Number of events 20 • side effects collected over 10 days
During light exposure patients were asked to evaluate the intensity of pain using a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain. Local skin reactions (erythema, edema, pustules, crusts, erosions and ulcerations) were recorded as well as any systemic adverse events during treatment and after follow-up visits. Clinical assessments of the local skin reactions were performed on a pre-defined scale as: 0 = no reaction, + mild, ++ moderate, +++ severe
|
Additional Information
Dr Luis Torezan Associate Professor Dermatology
University of Sao Paulo Medical School Brazil
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place