Actinic KeratosesPhase 1NCT03322293
Daylight Photodynamic Therapy for Actinic Keratosis
A Phase 1 study testing Aminolevulinic Acid Topical 20% Topical Solution and BLU-U blue light phototherapy illuminator in people with Actinic Keratoses, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized, single-blind controlled trial with parallel group design to determine whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of pain, burning, and pruritus as measured by 1) symptom level during the treatment period and 2) pain at the end of treatment exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Aminolevulinic Acid Topical 20% Topical Solution and BLU-U blue light phototherapy illuminator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Jul 2019
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years old.
- Subjects must be able to read, sign, and understand the informed consent
- Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp.
- Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.
- Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study.
- Subject must be willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions, and telephone interview.
- If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period are excluded from the study.
Who cannot join
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
- Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability and Efficacy of Daylight Aminolevulinic-acid-photodynamic Therapy (ALA-PDT) Compared With Conventional ALA-PDT for Treatment of Actinic Keratosis on the Face or Scalp
This is a randomized, single-blind controlled trial with parallel group design to determine whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of pain, burning, and pruritus as measured by 1) symptom level during the treatment period and 2) pain at the end of treatment exposure.
Read the detailed description
Actinic keratoses (AK) are common precancerous skin lesions that arise on sun-damaged skin. Treatment is aimed at preventing progression to cutaneous squamous cell carcinoma (SCC). First-line therapy for clinically apparent lesions includes cryotherapy and curettage; and field therapy options are topical 5-fluorouracil, imiquimod, ingenol mebutate, and photodynamic therapy (PDT). PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. In response, rapidly proliferating, dysplastic cells preferentially accumulate protoporphyrin IX (PpIX). When PpIX is activated by blue or red light, singlet oxygen species are produced, resulting in cell death. PDT is beneficial due to its brief treatment course and efficacy in clearing AK. However, its main drawbacks are the adverse effects of pain, burning, pruritus, erythema, crusting, and inflammation associated with treatment. While conventional PDT uses red or blue artificial light to activate a high concentration of accumulated protoporphyrins, daylight PDT uses natural daylight to activate lower levels of protoporphyrins in a continuous manner. Daylight PDT, when compared with conventional PDT, has been associated with significantly less pain while achieving comparable efficacy for the treatment of AK. Daylight PDT is also more cost-effective and reduces the amount of time spent in clinic. Previous randomized studies comparing daylight PDT with conventional PDT have largely used methyl-aminolevulinate as the photosensitizer, have been intra-individual comparative studies, and have been performed in Nordic countries. Because the effective light dose from natural daylight depends on geographic location and seasonal and weather changes, randomized trials in different geographic and environmental conditions are of interest. The proposed randomized clinical trial investigates the tolerability and efficacy of daylight ALA-PDT for the treatment of AK in San Francisco for the first time; subjects will be randomized to various treatment arms, as opposed to previous split-face and intra-individual studies.
- Conditions
- Actinic Keratoses
- Being tested
- Aminolevulinic Acid Topical 20% Topical Solution, BLU-U blue light phototherapy illuminator
- Keywords
- Actinic Keratoses, photodynamic therapy, aminolevulinic acid, precancerous skin lesion
- 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 Acid Topical 20% Topical SolutionDrug
PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
BLU-U blue light phototherapy illuminatorDevice
Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.
| Study group | Role | What they receive |
|---|---|---|
| A. Conventional arm | Active comparator | This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen.
Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Receives: Drug: Aminolevulinic Acid Topical 20% Topical Solution; Device: BLU-U blue light phototherapy illuminator |
| B. Combination arm | Experimental | This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure.
Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Receives: Drug: Aminolevulinic Acid Topical 20% Topical Solution; Device: BLU-U blue light phototherapy illuminator |
| C. Daylight arm | Experimental | This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure.
Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Receives: Drug: Aminolevulinic Acid Topical 20% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Symptoms
Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases.
Measured: 12 weeks
Secondary outcomes (4)
Percent Change in AK Lesion Count
The number of actinic keratoses within the treatment area was counted both pre and post-treatment. Then, the mean percent change from baseline actinic keratosis lesion count was calculated for each treatment group.
Measured: 12 weeks
Reduction of AK Counts
The number of AK lesions within the treatment area was assessed both pre and post-treatment. Then, the number of participants with various levels of AK lesion reduction (100% reduction or greater than 75% reduction) was calculated for each treatment group. This outcome measures the proportion of subjects with complete (100%) and partial (greater than or equal to 75%) reduction of baseline actinic keratosis lesion counts at 12 weeks (study end).
Measured: 12 weeks
Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment
To determine whether daylight PDT affords a reduction in local skin reaction to treatment. A Local Skin Response Assessment scale will be used to measure this outcome. The investigators will grade categories including Erythema, Flaking/Scaling, crusting, swelling, Pustulation (pustules), and Erosion, on a 0-4 scale (total maximum score of 24). A higher score indicates more erythema, flaking, crusting, etc. and therefore a more robust skin reaction. A score of 0 represents no erythema, flaking, crusting, etc.
Measured: 12 weeks
Peak Pain Score at Day 8 Post-treatment
Pain was measured by patient report with a visual analog scale from 0-10. 0 indicates no pain and 10 indicates the maximum pain score.
Measured: 8 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2018
- Study completion1 Jul 2019
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 KeratosesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1:1), single-blind controlled trial with parallel group design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Arron, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322293
- Sponsor's protocol ID
- Daylight PDT
- Status last verified
- Mar 2022
- First submitted
- 9 May 2017
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Efficacy of Daylight Aminolevulinic-acid-photodynamic Therapy (ALA-PDT) Compared With Conventional ALA-PDT for Treatment of Actinic Keratosis on the Face or Scalp
- ClinicalTrials.gov ID
- NCT03322293
- Acronym / sponsor ID
- Daylight PDT
- Conditions
- Actinic Keratoses
- Keywords
- Actinic Keratoses, photodynamic therapy, aminolevulinic acid, precancerous skin lesion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single-blind controlled trial with parallel group design to determine whether daylight photodynamic therapy (PDT) affords a reduction in treatment symptoms of pain, burning, and pruritus as measured by 1) symptom level during the treatment period and 2) pain at the end of treatment exposure.
Detailed description
Actinic keratoses (AK) are common precancerous skin lesions that arise on sun-damaged skin. Treatment is aimed at preventing progression to cutaneous squamous cell carcinoma (SCC). First-line therapy for clinically apparent lesions includes cryotherapy and curettage; and field therapy options are topical 5-fluorouracil, imiquimod, ingenol mebutate, and photodynamic therapy (PDT). PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. In response, rapidly proliferating, dysplastic cells preferentially accumulate protoporphyrin IX (PpIX). When PpIX is activated by blue or red light, singlet oxygen species are produced, resulting in cell death. PDT is beneficial due to its brief treatment course and efficacy in clearing AK. However, its main drawbacks are the adverse effects of pain, burning, pruritus, erythema, crusting, and inflammation associated with treatment. While conventional PDT uses red or blue artificial light to activate a high concentration of accumulated protoporphyrins, daylight PDT uses natural daylight to activate lower levels of protoporphyrins in a continuous manner. Daylight PDT, when compared with conventional PDT, has been associated with significantly less pain while achieving comparable efficacy for the treatment of AK. Daylight PDT is also more cost-effective and reduces the amount of time spent in clinic. Previous randomized studies comparing daylight PDT with conventional PDT have largely used methyl-aminolevulinate as the photosensitizer, have been intra-individual comparative studies, and have been performed in Nordic countries. Because the effective light dose from natural daylight depends on geographic location and seasonal and weather changes, randomized trials in different geographic and environmental conditions are of interest. The proposed randomized clinical trial investigates the tolerability and efficacy of daylight ALA-PDT for the treatment of AK in San Francisco for the first time; subjects will be randomized to various treatment arms, as opposed to previous split-face and intra-individual studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Randomized (1:1:1), single-blind controlled trial with parallel group design
| Arm | Type | Receives |
|---|---|---|
| A. Conventional arm | Active comparator | Drug: Aminolevulinic Acid Topical 20% Topical Solution, Device: BLU-U blue light phototherapy illuminatorThis is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator |
| B. Combination arm | Experimental | Drug: Aminolevulinic Acid Topical 20% Topical Solution, Device: BLU-U blue light phototherapy illuminatorThis treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator |
| C. Daylight arm | Experimental | Drug: Aminolevulinic Acid Topical 20% Topical SolutionThis is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults at least 18 years old.
- Subjects must be able to read, sign, and understand the informed consent
- Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp.
- Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.
- Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study.
Key exclusion criteria (3 listed)
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
- Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.
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 Topical 20% Topical SolutionPDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). | Drug | A. Conventional arm, B. Combination arm, C. Daylight arm |
| BLU-U blue light phototherapy illuminatorDepending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not. | Device | A. Conventional arm, B. Combination arm |
Primary outcome
Change in Treatment Symptoms
Time frame: 12 weeks
Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases.
4 secondary outcomes
Percent Change in AK Lesion Count
Time frame: 12 weeks
Reduction of AK Counts
Time frame: 12 weeks
Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment
Time frame: 12 weeks
Peak Pain Score at Day 8 Post-treatment
Time frame: 8 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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.
Sarah Arron, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aminolevulinic Acid Topical 20% Topical Solution and BLU-U blue light phototherapy illuminator in people with Actinic Keratoses, run by University of California, San Francisco 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 7 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: finished, as of the sponsor's last update on 9 Mar 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Oct 2019). 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?
Change in Treatment Symptoms (time frame: 12 weeks). 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 9 Mar 2022.