Actinic KeratosisPhase 4NCT03327831
Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
A Phase 4 study testing Aminolevulinic Acid in people with Actinic Keratosis, run by University of California, Irvine at 1 site in United States.
Trial summary
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Aminolevulinic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of >10 actinic keratoses on head and neck
- Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study)
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
- Topical imiquimod
- Topical 5-fluorouracil
- Topical ingenol mebutate
- Topical diclofenac
- Topical retinoids
Show all 11Show fewer
- Oral acitretin
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid
- Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.
- Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697-2400
About this study
Official title: UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.
Read the detailed description
- Initial Visit:
- study inclusion criteria reviewed
- consent forms reviewed
- creation of facial map for actinic keratoses
- face cleansed with chlorhexidine soap
- light curettage of precancerous skin lesions
- application of topical aminolevulinic acid (ALA)
- application of sunscreen
- patient then spends 2 hours outdoors in a shaded area
- after treatment the patient is to remain indoors for 48 hours
- 3 month follow up visit
- facial map of actinic keratoses used to document treatment response
- 6 month follow up visit
- facial map of actinic keratoses used to document treatment response
- Conditions
- Actinic Keratosis
- Being tested
- Aminolevulinic Acid
- Keywords
- aminolevulinic acid, pdt, photodynamic therapy, Photochemotherapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic AcidDrug
Also called Kerastick
Topical application followed by activation by ambient sunlight
| Study group | Role | What they receive |
|---|---|---|
| Aminolevulinic Acid with daylight photodynamic therapy arm | Experimental | This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Receives: Drug: Aminolevulinic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in the Number of Actinic Keratoses
Percent change in number of actinic keratoses at 6 months
Measured: 0 (baseline) and 6 months
Secondary outcomes (1)
Number of Participants With Adverse Events
Number of participants with adverse events such as crusting, erythema, edema, or pain
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startApr 2015
- Primary completionFeb 2017
- Study completionJul 2017
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 Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Zachary, University of California, Irvine
- Investigators
- Christopher B Zachary, MBBS. FRC[, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327831
- Sponsor's protocol ID
- 20151889
- Status last verified
- Jun 2024
- First submitted
- 23 Oct 2015
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
- ClinicalTrials.gov ID
- NCT03327831
- Acronym / sponsor ID
- 20151889
- Conditions
- Actinic Keratosis
- Keywords
- aminolevulinic acid, pdt, photodynamic therapy, Photochemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.
Detailed description
- Initial Visit:
- study inclusion criteria reviewed
- consent forms reviewed
- creation of facial map for actinic keratoses
- face cleansed with chlorhexidine soap
- light curettage of precancerous skin lesions
- application of topical aminolevulinic acid (ALA)
- application of sunscreen
- patient then spends 2 hours outdoors in a shaded area
- after treatment the patient is to remain indoors for 48 hours
- 3 month follow up visit
- facial map of actinic keratoses used to document treatment response
- 6 month follow up visit
- facial map of actinic keratoses used to document treatment response
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aminolevulinic Acid with daylight photodynamic therapy arm | Experimental | Drug: Aminolevulinic AcidThis study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of >10 actinic keratoses on head and neck
- Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study)
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (11 listed)
- Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid
- Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.
- Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
- pregnancy
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: KerastickTopical application followed by activation by ambient sunlight | Drug | Aminolevulinic Acid with daylight photodynamic therapy arm |
Primary outcome
Percent Change in the Number of Actinic Keratoses
Time frame: 0 (baseline) and 6 months
Percent change in number of actinic keratoses at 6 months
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christopher B Zachary, MBBS. FRC[ principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aminolevulinic Acid in people with Actinic Keratosis, run by University of California, Irvine 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 3 inclusion and 11 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 27 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Jun 2024). 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?
Percent Change in the Number of Actinic Keratoses (time frame: 0 (baseline) and 6 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 27 Jun 2024.