Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

This study has been completed.
Sponsor:
Collaborator:
Galderma Canada
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT00926952
First received: June 23, 2009
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Methylaminolevulinate (Metvix, Metvixia)
Device: Photodynamic Therapy (Aktilite)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.

Resource links provided by NLM:


Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:
  • Mean Number of Facial Actinic Keratoses at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: No ]
  • Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 20
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAL-PDT 90 min incubation, no occlusion
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.
Drug: Methylaminolevulinate (Metvix, Metvixia)
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.
Other Name: Metvix, Metvixia
Device: Photodynamic Therapy (Aktilite)
Device set to 37 J/cm². Red light wavelength is approximately 630 nm.
Other Name: Aktilite

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926952

Locations
Canada, Quebec
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Innovaderm Research Inc.
Galderma Canada
Investigators
Principal Investigator: Robert Bissonnette, MD, FRCPC Innovaderm Research
  More Information

Publications:
Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00926952     History of Changes
Other Study ID Numbers: Inno-6010
Study First Received: June 23, 2009
Results First Received: January 21, 2011
Last Updated: September 1, 2011
Health Authority: Canada: Health Canada

Keywords provided by Innovaderm Research Inc.:
Actinic keratoses
actinic keratosis
methylamonolevulinate
photodynamic therapy
without occlusion
short incubation

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014