Actinic KeratosisNCT00814528
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
A study testing 5-ALA plus Blu-Light and 5-FU, Imiquimod or treatment with cryotherapy in people with Actinic Keratosis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- 5-ALA plus Blu-Light and 5-FU, Imiquimod or treatment with cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2009
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-95 years old
- Diagnosied with actinic keratoses.
Who cannot join
- Patients who have had Isotretinoin therapy less that 1 year prior to screening.
- Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
- History of porphyria
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).
- Conditions
- Actinic Keratosis
- Being tested
- 5-ALA plus Blu-Light, 5-FU, Imiquimod or treatment with cryotherapy
- Keywords
- actinic keratosis, skin lesions, 5-ALA, AK, Blu-Light
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ALA plus Blu-LightDrug
20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.
5-FU, Imiquimod or treatment with cryotherapyDrug
Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm). Receives: Drug: 5-ALA plus Blu-Light |
| 2 | Experimental | 5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin. Receives: Drug: 5-FU, Imiquimod or treatment with cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actinic keratosis /incomplete therapy and reoccurence
Measured: 18 months
Secondary outcomes (1)
Erythema
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
Measured: 2 weeks post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: The study never started due to the Principal Investigator leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Tsoukas, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814528
- Sponsor's protocol ID
- 15725A
- Status last verified
- Sep 2018
- First submitted
- 23 Dec 2008
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
- ClinicalTrials.gov ID
- NCT00814528
- Acronym / sponsor ID
- 15725A
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, skin lesions, 5-ALA, AK, Blu-Light
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started due to the Principal Investigator leaving the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Dec 2008 (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 treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5-ALA plus Blu-LightApplication of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm). |
| 2 | Experimental | Drug: 5-FU, Imiquimod or treatment with cryotherapy5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-95 years old
- Diagnosied with actinic keratoses.
Key exclusion criteria (3 listed)
- Patients who have had Isotretinoin therapy less that 1 year prior to screening.
- Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
- History of porphyria
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 |
|---|---|---|
| 5-ALA plus Blu-Light20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response. | Drug | 1 |
| 5-FU, Imiquimod or treatment with cryotherapyCryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks. | Drug | 2 |
Primary outcome
Actinic keratosis /incomplete therapy and reoccurence
Time frame: 18 months
1 secondary outcome
Erythema
Time frame: 2 weeks post therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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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.
Maria Tsoukas, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-ALA plus Blu-Light and 5-FU, Imiquimod or treatment with cryotherapy in people with Actinic Keratosis, run by University of Chicago 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?
The sponsor lists 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Sep 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Actinic keratosis /incomplete therapy and reoccurence (time frame: 18 months). 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 10 Sep 2018.