Back to resultsShort Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Methylaminolevulinate (Metvix, Metvixia)
Photodynamic Therapy (Aktilite)
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic keratoses, actinic keratosis, methylamonolevulinate, photodynamic therapy, without occlusion, short incubation
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older.
- Patient with at least 5 actinic keratoses of the face at Day 0.
- Patient was willing to use an adequate contraceptive method or was surgically sterile, post menopausal, abstinent or with a same sex partner. Adequate means of contraception included oral contraceptives, IUD in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0.
- Patient capable of giving informed consent.
Exclusion Criteria:
- Patient with allergy to methylaminolevulinate or any component of the vehicle which includes peanut and almond oil.
- Patient with clinically significant sensitivity to visible light, porphyria or porphyrin sensitivity.
- Patient used any topical treatment for actinic keratoses (including imiquimod and 5-fluouracil), on the face within 4 weeks preceding Day 0.
- Patient had cryotherapy or surgery on the face within 4 weeks preceding Day 0.
- Patient with any malignant skin lesion (such as basal cell carcinoma, invasive squamous cell carcinoma or Bowen's disease) on the face at Day 0.
- Patient used photodynamic therapy, with any topical or systemic photosensitizer within 8 weeks preceding Day 0.
- Patient was exposed to excessive ultraviolet radiation (UVB phototherapy, sun tanning salons) within the 4 weeks preceding Day 0.
- Patient used any investigational drug within 4 weeks preceding Day 0.
- Patient with problems of alcoholism or drug abuse in the past year.
- Patient with any unstable or serious uncontrolled medical condition.
- Current pregnancy or lactation.
- Patient with any serious dermatological disorder, including malignancies that would either put the patient at risk or interfere with efficacy or safety evaluations.
- Patient with Fitzpatrick phototype IV, V or VI (inadequate penetration of red light in dark skinned subjects.
- Patients with extensive facial hair (e.g., beard) that would either impair red light exposure or interfere with lesion evaluation.
Sites / Locations
- Innovaderm Research Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MAL-PDT 90 min incubation, no occlusion
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean Number of Facial Actinic Keratoses at Week 12
Secondary Outcome Measures
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.
Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12
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.
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
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
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
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
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
Full Information
NCT ID
NCT00926952
First Posted
June 23, 2009
Last Updated
September 1, 2011
Sponsor
Innovaderm Research Inc.
Collaborators
Galderma Canada
1. Study Identification
Unique Protocol Identification Number
NCT00926952
Brief Title
Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
Official Title
Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.
Collaborators
Galderma Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic keratoses, actinic keratosis, methylamonolevulinate, photodynamic therapy, without occlusion, short incubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAL-PDT 90 min incubation, no occlusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylaminolevulinate (Metvix, Metvixia)
Other Intervention Name(s)
Metvix, Metvixia
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Photodynamic Therapy (Aktilite)
Other Intervention Name(s)
Aktilite
Intervention Description
Device set to 37 J/cm². Red light wavelength is approximately 630 nm.
Primary Outcome Measure Information:
Title
Mean Number of Facial Actinic Keratoses at Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12
Description
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.
Time Frame
12 weeks
Title
Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12
Time Frame
0, 12 weeks
Title
Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12
Description
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.
Time Frame
12 weeks
Title
Mean Fine Wrinkling Score at Week 12
Description
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
Time Frame
12 weeks
Title
Mean Coarse Wrinkling Score at Week 12
Description
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
Time Frame
12 weeks
Title
Mean Sallowness Score at Week 12
Description
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
Time Frame
12 weeks
Title
Mean Mottled Hyperpigmentation at Week 12
Description
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
Time Frame
12 weeks
Title
Number of Adverse Events
Description
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
Time Frame
12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older.
Patient with at least 5 actinic keratoses of the face at Day 0.
Patient was willing to use an adequate contraceptive method or was surgically sterile, post menopausal, abstinent or with a same sex partner. Adequate means of contraception included oral contraceptives, IUD in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0.
Patient capable of giving informed consent.
Exclusion Criteria:
Patient with allergy to methylaminolevulinate or any component of the vehicle which includes peanut and almond oil.
Patient with clinically significant sensitivity to visible light, porphyria or porphyrin sensitivity.
Patient used any topical treatment for actinic keratoses (including imiquimod and 5-fluouracil), on the face within 4 weeks preceding Day 0.
Patient had cryotherapy or surgery on the face within 4 weeks preceding Day 0.
Patient with any malignant skin lesion (such as basal cell carcinoma, invasive squamous cell carcinoma or Bowen's disease) on the face at Day 0.
Patient used photodynamic therapy, with any topical or systemic photosensitizer within 8 weeks preceding Day 0.
Patient was exposed to excessive ultraviolet radiation (UVB phototherapy, sun tanning salons) within the 4 weeks preceding Day 0.
Patient used any investigational drug within 4 weeks preceding Day 0.
Patient with problems of alcoholism or drug abuse in the past year.
Patient with any unstable or serious uncontrolled medical condition.
Current pregnancy or lactation.
Patient with any serious dermatological disorder, including malignancies that would either put the patient at risk or interfere with efficacy or safety evaluations.
Patient with Fitzpatrick phototype IV, V or VI (inadequate penetration of red light in dark skinned subjects.
Patients with extensive facial hair (e.g., beard) that would either impair red light exposure or interfere with lesion evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD, FRCPC
Organizational Affiliation
Innovaderm Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
1550366
Citation
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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Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
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