Trial Outcomes & Findings for Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion (NCT NCT00926952)

NCT ID: NCT00926952

Last Updated: 2011-09-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2011-09-09

Participant Flow

Recruitment period lasted from July 30, 2009 to July 14, 2010. Type of location was a medical research clinic.

Participant milestones

Measure	MAL-PDT 90 Min Incubation, no Occlusion Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

Baseline characteristics by cohort

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age Continuous	65.25 years STANDARD_DEVIATION 10.73 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants
Mean Number of Actinic Keratosis lesions on face	9.85 Lesions STANDARD_DEVIATION 7.88 • n=5 Participants
Mean Griffiths Photonumeric Scale for Photodamage Score	5.40 Units on a scale. STANDARD_DEVIATION 1.60 • n=5 Participants
Descriptive Scale -Mean Fine Wrinkling	5.40 Units on a scale STANDARD_DEVIATION 1.76 • n=5 Participants
Descriptive Scale - Mean Coarse Wrinkling	5.00 Units on a scale STANDARD_DEVIATION 2.20 • n=5 Participants
Descriptive Scale - Mean Sallowness	3.60 Units on a scale STANDARD_DEVIATION 2.37 • n=5 Participants
Descriptive Scale - Mean Mottled Hyperpigmentation	4.45 Units on a scale STANDARD_DEVIATION 2.14 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Number of Facial Actinic Keratoses at Week 12	2.70 Lesions Standard Deviation 2.32

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline.

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12	3 Participants

SECONDARY outcome

Timeframe: 0, 12 weeks

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12 Day 0 - Total lesions at baseline	197 Lesions
Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12 Week 12 - Lesions with complete clinical response	143 Lesions

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12	4.85 Units on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.

Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Fine Wrinkling Score at Week 12	4.30 Units on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.

Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Coarse Wrinkling Score at Week 12	4.55 Units on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).

Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Sallowness Score at Week 12	3.10 Units on a scale Standard Deviation 2.34

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.

Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Mean Mottled Hyperpigmentation at Week 12	4.40 Units on a scale Standard Deviation 1.64

SECONDARY outcome

Timeframe: 12, 24 weeks

Population: The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.

To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24

Outcome measures

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 Participants Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Number of Adverse Events Week 12	11 Adverse events
Number of Adverse Events Week 24	0 Adverse events

Adverse Events

MAL-PDT 90 Min Incubation, no Occlusion

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 participants at risk Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1

Other adverse events

Measure	MAL-PDT 90 Min Incubation, no Occlusion n=20 participants at risk Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
Skin and subcutaneous tissue disorders Burning sensation on forehead	5.0% 1/20 • Number of events 1
Eye disorders Vitreous detachment left eye	5.0% 1/20 • Number of events 1
Infections and infestations Common Cold	15.0% 3/20 • Number of events 3
General disorders Erythema application site	95.0% 19/20 • Number of events 19
General disorders Crusting application site	5.0% 1/20 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma face	5.0% 1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sore Throat	5.0% 1/20 • Number of events 1

Additional Information

Annie Levesque

Innovaderm Research Inc.

Phone: 514-521-4285

Email: alevesque@innovaderm.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place