Actinic KeratosesPhase 1/2NCT02149342
Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL
A Phase 1/2 study testing Hexylaminolaevulinate cream and Methylaminolaevulinate cream in people with Actinic Keratoses, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Hexylaminolaevulinate cream and Methylaminolaevulinate cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFinland
- Study dates
- May 2014to Sep 2015
- Phase
- Phase 1/2
- 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
- -Symmetrical actinic damage on face or scalp
Who cannot join
- Pregnancy
- Lactation
- Allergy to photosensitizer
- Photodermatose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate
This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.
Read the detailed description
Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.
- Conditions
- Actinic Keratoses
- Being tested
- Hexylaminolaevulinate cream, Methylaminolaevulinate cream
- Keywords
- Actinic keratoses, Daylight-PDT, Hexylaminolaevulinate, HAL, Methylaminolaevulinate, MAL, Hyperspectral imaging
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexylaminolaevulinate creamDrug
Also called HAL, Hexvix, Photocure
0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)
Methylaminolaevulinate creamDrug
Also called 16% Methylaminolaevulinate (Metvix, Galderma) cream, MAL
MAL 16% is used as photosensitizer for daylight-PDT
| Study group | Role | What they receive |
|---|---|---|
| HAL cream and MAL cream | Experimental | 0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design Receives: Drug: Hexylaminolaevulinate cream; Drug: Methylaminolaevulinate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Lesion Clearance
Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)
Measured: Baseline, 3 months
Secondary outcomes (3)
Clinical Lesion Clearance
Clinical lesion clearance is observed by a blinded observer
Measured: Baseline, 3 months
Adverse Reactions
Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.
Measured: One week
Pain Assesment (Visual Analog Scale)
Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Noora E Neittaanmäki-Perttu, MD, Principal investigator, Päijät-Häme Cnetral Hospital, Helsinki University Central HospitalMari Grönroos, MD, PhD, Study director, Päijät Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149342
- Sponsor's protocol ID
- 2013-001389-40
- Status last verified
- May 2016
- First submitted
- 19 May 2014
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: International peer-reviewed publication
Publications
Neittaanmaki-Perttu N, Gronroos M, Karppinen TT, Tani TT, Snellman E. Hexyl-5-aminolaevulinate 0.2% vs. methyl-5-aminolaevulinate 16% daylight photodynamic therapy for treatment of actinic keratoses: results of a randomized double-blinded pilot trial. Br J Dermatol. 2016 Feb;174(2):427-9. doi: 10.1111/bjd.13924. Epub 2015 Nov 20. No abstract available.
PubMed 26011755
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate
- ClinicalTrials.gov ID
- NCT02149342
- Acronym / sponsor ID
- 2013-001389-40
- Conditions
- Actinic Keratoses
- Keywords
- Actinic keratoses, Daylight-PDT, Hexylaminolaevulinate, HAL, Methylaminolaevulinate, MAL, Hyperspectral imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.
Detailed description
Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAL cream and MAL cream | Experimental | Drug: Hexylaminolaevulinate cream, Drug: Methylaminolaevulinate cream0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Symmetrical actinic damage on face or scalp
Key exclusion criteria (4 listed)
- Pregnancy
- Lactation
- Allergy to photosensitizer
- Photodermatose
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 |
|---|---|---|
| Hexylaminolaevulinate creamAlso: HAL, Hexvix, Photocure0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014) | Drug | HAL cream and MAL cream |
| Methylaminolaevulinate creamAlso: 16% Methylaminolaevulinate (Metvix, Galderma) cream, MALMAL 16% is used as photosensitizer for daylight-PDT | Drug | HAL cream and MAL cream |
Primary outcome
Histological Lesion Clearance
Time frame: Baseline, 3 months
Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)
3 secondary outcomes
Clinical Lesion Clearance
Time frame: Baseline, 3 months
Adverse Reactions
Time frame: One week
Pain Assesment (Visual Analog Scale)
Time frame: 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26011755Neittaanmaki-Perttu N, Gronroos M, Karppinen TT, Tani TT, Snellman E. Hexyl-5-aminolaevulinate 0.2% vs. methyl-5-aminolaevulinate 16% daylight photodynamic therapy for treatment of actinic keratoses: results of a randomized double-blinded pilot trial. Br J Dermatol. 2016 Feb;174(2):427-9. doi: 10.1111/bjd.13924. Epub 2015 Nov 20. No abstract available.
- Individual participant dataSharing planned: Yes. International peer-reviewed publication
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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.
Noora E Neittaanmäki-Perttu, MD principal investigator
Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital
Mari Grönroos, MD, PhD study director
Päijät Häme Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hexylaminolaevulinate cream and Methylaminolaevulinate cream in people with Actinic Keratoses, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
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 1 inclusion and 4 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 11 Jul 2016. 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 Finland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Jul 2016). 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?
Histological Lesion Clearance (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149342, which also lists 1 linked publication.
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 11 Jul 2016.