Actinic KeratosesPhase 2NCT00865878
ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients
A Phase 2 study testing Aminolevulinic Acid in people with Actinic Keratoses and Skin Neoplasms, run by DUSA Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of the scalp or both forearms in solid organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses, Skin Neoplasms
- What is being tested?
- Aminolevulinic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2009to Sep 2011
- Phase
- Phase 2
- 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
- Subject is male or non-pregnant female organ transplant (kidney, liver, pancreas, lungs, heart or combinations thereof) recipient outpatient 18 years of age or older. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent.
- Subject has at least 3 actinic keratosis lesions in a continuous 25 cm2 Target Area within the selected anatomic treatment site (scalp or forearm).
- Subject has a history of a minimum of 2 NMSC on the treatment area of interest (scalp OR both forearms) in the past 12 months
- Subject is currently receiving standard active pharmacologic immunosuppression
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject has Fitzpatrick skin type I-IV.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
- Subject has any skin pathology or condition, in the investigator's opinion, that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject is currently enrolled in an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or device study. Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
- Subject has received an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
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- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
- Subject has active recurrent herpes simplex labialis infection in the treatment area with an outbreak within the last 12 months and will not be placed on antiviral prophylaxis as specified in the protocol.
- Subject has used any of the following topical preparations on the selected Treatment Area (scalp OR both forearms):
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- 5-FU, cryotherapy, diclofenac, imiquimod or other treatments for AK within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT or chemical peels within 8 weeks of the initiation of treatment.
- Two or more ALA PDT treatments in the past 6 months
- Subject has used systemic retinoid therapy within 6 months of the initiation of treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center
Boston, Massachusetts, 02111
University of California, Irvine
Irvine, California, 92697
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
The Mount Sinai Medical Center
New York, New York, 10029
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients
The purpose of this study is to determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of the scalp or both forearms in solid organ transplant recipient subjects receiving chronic immunosuppressive therapy.
Read the detailed description
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group study of photodynamic therapy in organ transplant recipient subjects for treatment of AK and the reduction of new NMSC.
Subjects will be randomized to one of the following two treatment groups (1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
- Group 2 will have VEH applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
Treatment Area (scalp or both forearms) must have had at least 2 NMSC in the past 12 months, and must include a continuous 25 cm2 Target Area containing a minimum of 3 AKs, to be eligible for treatment
Each subject may receive up to nine treatments. The initial four (4) ALA-PDT/VEH-PDT treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. Post-treatment follow-up visit will be scheduled to occur 4 weeks after the subject's final PDT.
- Conditions
- Actinic Keratoses, Skin Neoplasms
- Being tested
- Aminolevulinic Acid, Vehicle
- Keywords
- Actinic Keratoses, Skin Neoplasms, Photodynamic Therapy, Transplants
- Medical subject headings
- Keratosis, Actinic, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic AcidDrug
Also called Levulan
20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
VehicleOther
Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Topical Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes and 40 seconds. Receives: Drug: Aminolevulinic Acid |
| 2 | Placebo comparator | Kerastick containing vehicle ingredients only (VEH) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes 40 seconds. Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Skin Cancers within the Treatment Area
Measured: entire study
AK Lesions Counts/Surface Area
Measured: Visits 1,3,5,7,9,11,13,15,17,19
Investigator Global Assessment
Measured: Visits 1,3,5,7,9,11,13,15,17,19
Secondary outcomes (2)
Subject Acceptability of Treatment
Measured: End of Study
Tolerability Parameters
Measured: Each Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Orphan Drug Designation for this indication not granted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart L Marcus, MD, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865878
- Sponsor's protocol ID
- DUSA-CP0104
- Status last verified
- Oct 2011
- First submitted
- 18 Mar 2009
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00865878
- Acronym / sponsor ID
- DUSA-CP0104
- Conditions
- Actinic Keratoses, Skin Neoplasms
- Keywords
- Actinic Keratoses, Skin Neoplasms, Photodynamic Therapy, Transplants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Orphan Drug Designation for this indication not granted
- Enrolment
- 6 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Mar 2009 (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 determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of the scalp or both forearms in solid organ transplant recipient subjects receiving chronic immunosuppressive therapy.
Detailed description
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group study of photodynamic therapy in organ transplant recipient subjects for treatment of AK and the reduction of new NMSC.
Subjects will be randomized to one of the following two treatment groups (1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
- Group 2 will have VEH applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
Treatment Area (scalp or both forearms) must have had at least 2 NMSC in the past 12 months, and must include a continuous 25 cm2 Target Area containing a minimum of 3 AKs, to be eligible for treatment
Each subject may receive up to nine treatments. The initial four (4) ALA-PDT/VEH-PDT treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. Post-treatment follow-up visit will be scheduled to occur 4 weeks after the subject's final PDT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Aminolevulinic AcidTopical Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes and 40 seconds. |
| 2 | Placebo comparator | Other: VehicleKerastick containing vehicle ingredients only (VEH) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes 40 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is male or non-pregnant female organ transplant (kidney, liver, pancreas, lungs, heart or combinations thereof) recipient outpatient 18 years of age or older. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent.
- Subject has at least 3 actinic keratosis lesions in a continuous 25 cm2 Target Area within the selected anatomic treatment site (scalp or forearm).
- Subject has a history of a minimum of 2 NMSC on the treatment area of interest (scalp OR both forearms) in the past 12 months
- Subject is currently receiving standard active pharmacologic immunosuppression
Key exclusion criteria (17 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
- Subject has any skin pathology or condition, in the investigator's opinion, that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject is currently enrolled in an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or device study. Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
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 |
|---|---|---|
| Aminolevulinic AcidAlso: Levulan20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. | Drug | 1 |
| VehicleVehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. | Other | 2 |
Primary outcome
Number of Skin Cancers within the Treatment Area
Time frame: entire study
AK Lesions Counts/Surface Area
Time frame: Visits 1,3,5,7,9,11,13,15,17,19
Investigator Global Assessment
Time frame: Visits 1,3,5,7,9,11,13,15,17,19
2 secondary outcomes
Subject Acceptability of Treatment
Time frame: End of Study
Tolerability Parameters
Time frame: Each Visit
Results and safety
The study was stopped early (reason given: Orphan Drug Designation for this indication not granted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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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.
Stuart L Marcus, MD, PhD study director
Sponsor GmbH
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolevulinic Acid in people with Actinic Keratoses and Skin Neoplasms, run by DUSA Pharmaceuticals, Inc. 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 7 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Oct 2011. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Orphan Drug Designation for this indication not granted). Results are not available in the source record.
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?
Number of Skin Cancers within the Treatment Area (time frame: entire study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2011.