This page shows what was measured, who it was measured in, and what that does not settle.
What Aminolevulinic Acid does in the body
Minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities
From the FDA-approved label: Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 88755TAZ87 · read 2026-08-29
Its recorded molecular formula is C5H9NO3·HCl, weighing 167.59.
US prescribing information · 650daa9f-aeec-49ce-95b9-5fa20b988afd · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 122 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
✗ The study did not show it
Who was studied
NCT00233402
How many people
789
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Tumor recurrence
✗ The study did not show it
Who was studied
NCT02660190
How many people
696
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT
✗ The study did not show it
Who was studied
NCT02799069
How many people
571
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants With Complete Response at Week 12
✗ The study did not show it
Who was studied
NCT04085367
How many people
557
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
✗ The study did not show it
Who was studied
NCT02191488
How many people
540
Study design
Phase 1
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
✗ The study did not show it
Who was studied
NCT00241670
How many people
415
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients below the age of 18 have not been established.”
US prescribing information · 650daa9f-aeec-49ce-95b9-5fa20b988afd · read 2026-08-30
On older people, the label states: “Of the 384 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 83% (318/384) of the subjects were 65 years old and over.”
US prescribing information · 650daa9f-aeec-49ce-95b9-5fa20b988afd · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no available data on AMELUZ use in pregnant women to inform a drug associated risk.”
US prescribing information · 650daa9f-aeec-49ce-95b9-5fa20b988afd · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary No data are available regarding the presence of aminolevulinic acid in human milk, the effects of aminolevulinic acid on the breastfed infant or on milk production.”
US prescribing information · 650daa9f-aeec-49ce-95b9-5fa20b988afd · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S4.
No source is stored against this line.
What is in the pack
Sold as for solution, solution, gel, powder, for solution, given by the oral, topical route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.
FDA National Drug Code directory · 73164-0002 · read 2026-08-29
They are sold as for solution, gel, powder and powder, for solution, taken oral and topical.
FDA National Drug Code directory · 73164-0002 · read 2026-08-29
The regulator's established pharmacologic class for it is fluorescence contrast activity [moa], optical imaging agent [epc] and porphyrin precursor [epc].
FDA National Drug Code directory · 73164-0002 · read 2026-08-29
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e45cc371-9ebc-4904-12bc-65cb4e2817ad · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e45cc371-9ebc-4904-12bc-65cb4e2817ad · read 2026-08-29
22310 marketed supplement labels list this ingredient, classed as botanical with nutrients, non-nutrient/non-botanical and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (8)
Q2
On the Aminolevulinic Acid label: indicated for what?
"1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.": indications and usage on Aminolevulinic Acid's label. DailyMed label · 650daa9f-aeec-49ce-95b9-5fa20b988afd · 2026-08-26
Q3
103 registered trials of Aminolevulinic Acid — at which phases?
Registered studies posting no result
75 of 103
103 registered studies of Aminolevulinic Acid: 44 phase2, 24 phase1, 14 phase3, 11 na, 9 phase4, 7 na or unstated, 5 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
413 with a PubMed record
Show the evidence
phase2
44
phase1
24
phase3
14
na
11
phase4
9
na or unstated
7
9 more recorded rows
early phase1
5
completed
58
terminated
13
unknown
9
recruiting
7
not yet recruiting
6
withdrawn
6
active not recruiting
3
suspended
1
recorded 2026-09-01 · last checked 2026-09-04
Q4
17 of Aminolevulinic Acid's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (4), funding/business (3) and other (10): Aminolevulinic Acid's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Withdrawn due to low accrual"; 17 of 103 registered studies
Show the evidence
Trial
NCT00524485
terminated; "Withdrawn due to low accrual"
NCT00663910
terminated; "Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous."
NCT00865878
terminated; "Orphan Drug Designation for this indication not granted"
NCT00977795
withdrawn; "PI moving to Southern Illinois University to start new protocol"
NCT01351519
terminated; "Limited staff available for enrollment and limited availability of drug"
NCT01502605
terminated; "PI leaving institution"
11 further recorded trials
NCT01522677
withdrawn; "Slow accrual"
NCT01575275
terminated; "Drugs unavailable"
NCT02728388
terminated; "data analysis unequivocal - requires study methodology re-evaluation"
NCT02867722
withdrawn; "The PI decided to not proceed with the trial due to lack of funding."
NCT03024060
withdrawn; "Study withdrawn due to corporate business decision"
NCT03897491
terminated; "Low recruitment activities of clinical trial sites."
NCT03963102
terminated; "Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended."
NCT04381806
suspended; "Study drug availability"
NCT04815083
terminated; "Study terminated due to closure of Sponsor business"
NCT05101798
terminated; "NX Development Corporation closed the trial"
NCT06252727
withdrawn; "PI choice."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Aminolevulinic Acid used Aminolevulinic acid hydrochloride 10% topical gel with Red Light — over how long?
studies of Aminolevulinic Acid used the recorded amount. ClinicalTrials.gov · 2026-09-01
1 recorded entry; human; topical; also "Aminolevulinic acid hydrochloride 10% topical gel with Red Light"
Show the evidence
humanNCT06577311
topical; Aminolevulinic acid hydrochloride 10% topical gel with Red Light
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which 25 trials of Aminolevulinic Acid posted no result?
Posted no result
25 of 25 completed trials
Registrations
NCT02755142, NCT02799030, NCT00002963, NCT00671710, NCT01508741 and NCT00870779, and 19 more
Completion dates
oldest 2001-06; newest 2023-10-31
Show the evidence
Trial
NCT02755142
2001-06
NCT02799030
2007-03
NCT00002963
2007-06
NCT00671710
2010-11
NCT01508741
2012-12
NCT00870779
2013-07-02
14 further recorded trials
NCT01610778
2013-09
NCT00961090
2015-04-23
NCT02101931
2016-03
NCT02209012
2016-04
NCT00978081
2016-11
NCT02622594
2017-04-13
NCT02464709
2017-10
NCT02685592
2018-03
NCT01502280
2018-06
NCT00752323
2018-10-14
NCT02632370
2018-12-31
NCT02155452
2019-07
NCT03114111
2019-12-04
NCT03281811
2020-08-12
Q7
At the median, Aminolevulinic Acid's trials enrolled 27 people — anything larger?
Median enrolment
27
Largest enrolment
571
Registered trials counted
102
Q8
What do 194 spontaneous reports say about Aminolevulinic Acid — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Aminolevulinic Acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 194 reaction mentions were counted: application site erythema 48; application site pain 33; erythema 22; application site swelling 16. FAERS via Open Targets · CHEMBL1200582 · 2026-06-24
Show the evidence
application site erythema
48
application site pain
33
erythema
22
application site swelling
16
blister
15
photophobia
14
4 more recorded rows
eye irritation
13
laceration
12
lacrimation increased
12
application site discolouration
9
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Aminolevulinic Acid's label not list?
application site discolouration, application site erythema and application site pain and 7 more reported for Aminolevulinic Acid, absent from its label. FAERS via Open Targets · CHEMBL1200582 · 2026-06-24
2 label terms; 10 reported and unlisted; 650daa9f-aeec-49ce-95b9-5fa20b988afd
Show the evidence
application site discolouration
count not stated
application site erythema
count not stated
application site pain
count not stated
application site swelling
count not stated
blister
count not stated
erythema
count not stated
4 more recorded rows
eye irritation
count not stated
laceration
count not stated
lacrimation increased
count not stated
photophobia
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.