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Actinic KeratosisPhase 3NCT00926952

Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

A Phase 3 study testing Methylaminolevulinate (Metvix, Metvixia) and Photodynamic Therapy (Aktilite) in people with Actinic Keratosis, run by Innovaderm Research Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratosis
What is being tested?
Methylaminolevulinate (Metvix, Metvixia) and Photodynamic Therapy (Aktilite)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Jul 2009to Jan 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Innovaderm Research Inc

    Montreal, Quebec, H2K 4L5

Other trials in Canada

About this study

Official title: Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.

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.

Read the 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.

Being tested
Methylaminolevulinate (Metvix, Metvixia), Photodynamic Therapy (Aktilite)
Keywords
Actinic keratoses, actinic keratosis, methylamonolevulinate, photodynamic therapy, without occlusion, short incubation
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylaminolevulinate (Metvix, Metvixia)Drug

    Also called 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.

  • Photodynamic Therapy (Aktilite)Device

    Also called Aktilite

    Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Study groups in NCT00926952
Study groupRoleWhat they receive
MAL-PDT 90 min incubation, no occlusionExperimentalPatients 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.
Receives: Drug: Methylaminolevulinate (Metvix, Metvixia); Device: Photodynamic Therapy (Aktilite)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Number of Facial Actinic Keratoses at Week 12

    Measured: 12 weeks

Secondary outcomes (8)

  1. 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.

    Measured: 12 weeks

  2. Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12

    Measured: 0, 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

  6. 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

    Measured: 12 weeks

  7. 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

    Measured: 12 weeks

  8. 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

    Measured: 12, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00926952
Sponsor's protocol ID
Inno-6010
Status last verified
Sep 2011
First submitted
23 Jun 2009
Last updated
9 Sep 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 1550366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylaminolevulinate (Metvix, Metvixia) and Photodynamic Therapy (Aktilite) in people with Actinic Keratosis, run by Innovaderm Research Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Facial Actinic Keratoses at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.

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