Precancerous/Nonmalignant ConditionNCT00524485
Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
A study testing aminolevulinic acid and laser therapy in people with Precancerous/Nonmalignant Condition, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Precancerous/Nonmalignant Condition
- What is being tested?
- aminolevulinic acid and laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 2009
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Actinic keratosis lesion located in any of the following body sites:
- Stratum 1*: face and neck, scalp, or upper torso
- At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
- Stratum 2*: arms or legs
- At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
- Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry
PATIENT CHARACTERISTICS:
- No porphyria or known hypersensitivity to porphyrins
- No known photosensitivity disease
- No known sensitivity to any components of aminolevulinic acid topical solution
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
- No other concurrent photosensitizer drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis.
PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.
Read the detailed description
OBJECTIVES:
Primary
- To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site.
- To determine the extent that the PpIX is photobleached by the treatment light.
Secondary
- To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT.
- To assess the effects of different treatment conditions on the efficacy of ALA-PDT.
- To examine the histological response to ALA-PDT.
- To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site.
- To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light.
OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT).
- Arm I: Patients receive topical ALA 2 hours before PDT.
- Arm II: Patients receive topical ALA 4 hours before PDT.
- Arm III: Patients receive topical ALA 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment.
- Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit.
- Arm V: 2 Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study.
Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.
- Conditions
- Precancerous/Nonmalignant Condition
- Being tested
- aminolevulinic acid, laser therapy
- Keywords
- actinic keratosis
- Medical subject headings
- Precancerous Conditions, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acidDrug
laser therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - ALA | Experimental | Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT. Receives: Drug: aminolevulinic acid |
| Arm 2 | Experimental | Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Receives: Drug: aminolevulinic acid |
| Arm 3 | Experimental | Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Receives: Drug: aminolevulinic acid |
| Arm 4 | Experimental | Vbeam laser pulse (photodynamic therapy) is applied to the subunit Receives: Procedure: laser therapy |
| Arm 5 | Experimental | Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart Receives: Procedure: laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light
Secondary outcomes (5)
Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
Effects of Different Treatment Conditions on Efficacy
Histological Response
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startMay 2005
- Primary completionJan 2009
- Study completionMay 2009
Why it stopped: Withdrawn due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Precancerous/Nonmalignant ConditionStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nathalie Zeitouni, MD,, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524485
- Sponsor's protocol ID
- I 28204
- Other IDs
- RPCI-I-28204
- Status last verified
- May 2017
- First submitted
- 31 Aug 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
- ClinicalTrials.gov ID
- NCT00524485
- Acronym / sponsor ID
- I 28204
- Conditions
- Precancerous/Nonmalignant Condition
- Keywords
- actinic keratosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis.
PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.
Detailed description
OBJECTIVES:
Primary
- To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site.
- To determine the extent that the PpIX is photobleached by the treatment light.
Secondary
- To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT.
- To assess the effects of different treatment conditions on the efficacy of ALA-PDT.
- To examine the histological response to ALA-PDT.
- To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site.
- To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light.
OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT).
- Arm I: Patients receive topical ALA 2 hours before PDT.
- Arm II: Patients receive topical ALA 4 hours before PDT.
- Arm III: Patients receive topical ALA 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment.
- Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit.
- Arm V: 2 Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study.
Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - ALA | Experimental | Drug: aminolevulinic acidPatients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT. |
| Arm 2 | Experimental | Drug: aminolevulinic acidPatients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT |
| Arm 3 | Experimental | Drug: aminolevulinic acidPatients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment |
| Arm 4 | Experimental | Procedure: laser therapyVbeam laser pulse (photodynamic therapy) is applied to the subunit |
| Arm 5 | Experimental | Procedure: laser therapyVbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 acid | Drug | Arm 1 - ALA, Arm 2, Arm 3 |
| laser therapy | Procedure or surgery | Arm 4, Arm 5 |
Primary outcome
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light
5 secondary outcomes
Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
Effects of Different Treatment Conditions on Efficacy
Histological Response
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nathalie Zeitouni, MD, principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aminolevulinic acid and laser therapy in people with Precancerous/Nonmalignant Condition, run by Roswell Park Cancer Institute at 1 site 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?
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 14 Jun 2017. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). 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?
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site. The study lists 2 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 14 Jun 2017.