Actinic KeratosisPhase 3NCT00306800
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
A Phase 3 study testing Photodynamic therapy with methyl aminolevulinate cream in people with Actinic Keratosis, run by Galderma R&D at 7 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin) on the face and / or scalp 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?
- Photodynamic therapy with methyl aminolevulinate cream
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2007to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
- Males or females above 18 years of age.
- Written informed consent
Who cannot join
- Patients with porphyria.
- Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
- Known allergy to MAL, a similar PDT compound or excipients of the cream.
- Patients with history of hypersensitivity to nut products or other known protein antigens.
- Participation in other clinical studies either currently or within the last 30 days.
- Patients receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
Show all 10Show fewer
- Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months.
- Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
- Any conditions that may be associated with a risk of poor protocol compliance.
- Patients currently receiving regular ultraviolet radiation therap
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dermresearch Inc
Austin, Texas, 78759
The Cleveland Clinic
Cleveland, Ohio, 44195
Texas Dermatology Research Institute
Dallas, Texas, 75230
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Laser and Skin Surgery Center
New York, New York, 10016
Dermatology Associates of Rochester
Rochester, New York, 14623
Spencer Dermatology and Skin Surgery
St. Petersburg, Florida, 33716-1115
About this study
Official title: A Multicenter, Double Blind, Vehicle-Controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 Mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp
The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin) on the face and / or scalp
Read the detailed description
Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple.
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.
Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) have been used for the activation of PAP, which absorbs light in the range of 400-700 nm. The present study uses the Aktilite CL 128 lamp. Aktilite 128 is based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study is similar to two other studies performed, on which the U.S. approval of Metvixia® cream is based except for the light source used. This study is one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia® cream.
Previous studies have shown that the risks attributed to Metvixia® PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.
- Conditions
- Actinic Keratosis
- Being tested
- Photodynamic therapy with methyl aminolevulinate cream
- Keywords
- Methyl aminolevulinate, Photodynamic therapy, Aktilite CL128 LED light source, Multiple Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy with methyl aminolevulinate creamProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Primary outcome: To compare the patient complete response rate of MAL PDT to that of vehicle PDT 3 months after the last treatment in patients with multiple actinic keratoses on the face and/or scalp
Secondary outcomes (1)
Secondary: The secondary outcomes: To compare local Adverse Events (treatment site Adverse Events (AEs) between MAL PDT and vehicle PDT; To compare the lesion complete response rate between MAL PDT and vehicle PDT 3 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Pariser, MD, Principal investigator, Virginia Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306800
- Sponsor's protocol ID
- PC T404/05
- Status last verified
- Sep 2010
- First submitted
- 22 Mar 2006
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003 Feb;48(2):227-32. doi: 10.1067/mjd.2003.49.
PubMed 12582393Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.
PubMed 12775317
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Vehicle-Controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 Mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp
- ClinicalTrials.gov ID
- NCT00306800
- Acronym / sponsor ID
- PC T404/05
- Conditions
- Actinic Keratosis
- Keywords
- Methyl aminolevulinate, Photodynamic therapy, Aktilite CL128 LED light source, Multiple Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 24 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin) on the face and / or scalp
Detailed description
Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple.
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.
Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) have been used for the activation of PAP, which absorbs light in the range of 400-700 nm. The present study uses the Aktilite CL 128 lamp. Aktilite 128 is based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study is similar to two other studies performed, on which the U.S. approval of Metvixia® cream is based except for the light source used. This study is one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia® cream.
Previous studies have shown that the risks attributed to Metvixia® PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
- Males or females above 18 years of age.
- Written informed consent
Key exclusion criteria (10 listed)
- Patients with porphyria.
- Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
- Known allergy to MAL, a similar PDT compound or excipients of the cream.
- Patients with history of hypersensitivity to nut products or other known protein antigens.
- Participation in other clinical studies either currently or within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapy with methyl aminolevulinate cream | Procedure or surgery | – |
Primary outcome
Primary: Primary outcome: To compare the patient complete response rate of MAL PDT to that of vehicle PDT 3 months after the last treatment in patients with multiple actinic keratoses on the face and/or scalp
1 secondary outcome
Secondary: The secondary outcomes: To compare local Adverse Events (treatment site Adverse Events (AEs) between MAL PDT and vehicle PDT; To compare the lesion complete response rate between MAL PDT and vehicle PDT 3 months after last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 12582393Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003 Feb;48(2):227-32. doi: 10.1067/mjd.2003.49.
- Background: PubMed 12775317Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pariser, MD principal investigator
Virginia Clinical Research
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photodynamic therapy with methyl aminolevulinate cream in people with Actinic Keratosis, run by Galderma R&D at 7 sites in United States.
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 3 inclusion and 10 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary: Primary outcome: To compare the patient complete response rate of MAL PDT to that of vehicle PDT 3 months after the last treatment in patients with multiple actinic keratoses on the face and/or scalp. 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 NCT00306800, which also lists 2 linked publications.
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 18 Feb 2021.