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| Name | Class |
|---|---|
| Galderma Canada | OTHER |
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Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.
A total of 20 patients with at least 5 non-hypertrophic actinic keratoses (AK) of the face were included in this open-label study. All AKs were mapped on a transparent template before the first PDT treatment. At Day 0, all patients received methylaminolevulinate (MAL) applied on the entire face (except the nose and peri-ocular area of 1-2 cm) without any skin preparation. One to two 2 g MAL tubes was used for the entire face. MAL was applied without occlusion. After a total of 90 +/- 5 minutes the skin was rinsed and exposed to 37 J/cm² of red light from an Aktilite™ device. Patients were seen at Week 4; if all facial AKs did not show a complete response to treatment, the MAL-PDT procedure was repeated at Week 4. Patients were seen again at Week 12 and 24.
The primary endpoint was at Week 12. Patients came back at Week 24 for a final safety evaluation and to verify the recurrence of AK.
Efficacy is evaluated by assessing the mean number of facial AK at Week 12 as compared to Day 0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAL-PDT 90 min incubation, no occlusion | Experimental | Patients had 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and waited 90 minutes prior to photodynamic therapy (PDT) using red light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylaminolevulinate (Metvix, Metvixia) | Drug | 2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Facial Actinic Keratoses at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12 | 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. | 12 weeks |
| Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD, FRCPC | Innovaderm Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1550366 | Background | Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51. |
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Recruitment period lasted from July 30, 2009 to July 14, 2010. Type of location was a medical research clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Facial Actinic Keratoses at Week 12 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Lesions | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation on forehead | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Levesque | Innovaderm Research Inc. | 514-521-4285 | 222 | alevesque@innovaderm.ca |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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|
| Photodynamic Therapy (Aktilite) | Device | Device set to 37 J/cm². Red light wavelength is approximately 630 nm. |
|
|
| 0, 12 weeks |
| Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12 | 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. | 12 weeks |
| Mean Fine Wrinkling Score at Week 12 | 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 | 12 weeks |
| Mean Coarse Wrinkling Score at Week 12 | 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 | 12 weeks |
| Mean Sallowness Score at Week 12 | 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 | 12 weeks |
| Mean Mottled Hyperpigmentation at Week 12 | 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 | 12 weeks |
| Number of Adverse Events | 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 | 12, 24 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Number of Actinic Keratosis lesions on face | Mean | Standard Deviation | Lesions |
|
| Mean Griffiths Photonumeric Scale for Photodamage Score | 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. | Mean | Standard Deviation | Units on a scale. |
|
| Descriptive Scale -Mean Fine Wrinkling | 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.
| Mean | Standard Deviation | Units on a scale |
|
| Descriptive Scale - Mean Coarse Wrinkling | 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.
| Mean | Standard Deviation | Units on a scale |
|
| Descriptive Scale - Mean Sallowness | This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).
| Mean | Standard Deviation | Units on a scale |
|
| Descriptive Scale - Mean Mottled Hyperpigmentation | 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.
| Mean | Standard Deviation | Units on a scale |
|
|
| Secondary | Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12 | 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. | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Number | Participants | 12 weeks |
|
|
|
| Secondary | Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12 | Posted | Number | Lesions | 0, 12 weeks |
|
|
|
| Secondary | Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12 | 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. | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Fine Wrinkling Score at Week 12 | 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 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Coarse Wrinkling Score at Week 12 | 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 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Sallowness Score at Week 12 | 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 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Mottled Hyperpigmentation at Week 12 | 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 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Number of Adverse Events | 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 | The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed. | Posted | Number | Adverse events | 12, 24 weeks |
|
|
|
| 1 |
| 20 |
| 20 |
| 20 |
| Vitreous detachment left eye | Eye disorders | Non-systematic Assessment |
|
| Common Cold | Infections and infestations | Non-systematic Assessment |
|
| Erythema application site | General disorders | Non-systematic Assessment |
|
| Crusting application site | General disorders | Non-systematic Assessment |
|
| Squamous cell carcinoma face | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |