Neoplasms, Basal CellPhase 1/2NCT02367547
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
A Phase 1/2 study testing Hexylaminolevulinate cream, Aminolevulinic Acid Nano Emulsion and Methylaminolevulinate cream in people with Neoplasms, Basal Cell and Carcinoma, Basal Cell, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Basal Cell, Carcinoma, Basal Cell, Photochemotherapy
- What is being tested?
- Hexylaminolevulinate cream, Aminolevulinic Acid Nano Emulsion and Methylaminolevulinate cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2015to Dec 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- superficial basal cell carcinomas on body area (clinically assessed to be mainly superficially growing and later on a biopsy proven sBCC or thin nBCC)
- lesions accepted needs to be 10 cm apart from each other
Who cannot join
- pigmented, morpheaform, infiltrative or nodular basal cell carcinomas
- lesions that are in face and scalp area
- pregnancy
- breast feeding
- allergy to photosensitizer
- phorphyria or photosensitivity
Trial locations and contacts
1 site in 1 country.
Finland1 site
Joint Authority for Päijät-Häme Social and Health Care
Lahti, 15850
About this study
Official title: Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Read the detailed description
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
- Being tested
- Hexylaminolevulinate cream, Aminolevulinic Acid Nano Emulsion, Methylaminolevulinate cream
- Medical subject headings
- Neoplasms, Basal Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexylaminolevulinate creamDrug
Also called HAL, Hexvix, Photocure
The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.
Aminolevulinic Acid Nano EmulsionDrug
Also called Ameluz, Biofrontera, L01XD04, BF-200 ALA
In the study we use Ameluz.
Methylaminolevulinate creamDrug
Also called Metvix, Galderma, L01X D03, MAL
In the study we use Metvix.
| Study group | Role | What they receive |
|---|---|---|
| Hexylaminolevulinate cream | Experimental | 2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream Receives: Drug: Hexylaminolevulinate cream |
| Aminolevulinic Acid Nano Emulsion | Experimental | 78 mg/g Aminolevulinic Acid Nano Emulsion Receives: Drug: Aminolevulinic Acid Nano Emulsion |
| Methylaminolevulinate cream | Active comparator | 160 mg/g Methylaminolevulinate cream Receives: Drug: Methylaminolevulinate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological lesion clearance
Measured: 3 months
Histological lesion clearance
Measured: 12 months
Histological lesion clearance
Measured: 5 years
Secondary outcomes (3)
Detection of subclinical lesion with hyperspectral imaging system
Measured: 3 months
Detection of subclinical lesion with hyperspectral imaging system
Measured: 12 months
Detection of subclinical lesion with hyperspectral imaging system
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2018
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Basal CellStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla
- Responsible party
- Sponsor
- Investigators
- Mari Grönroos, MD, PhD, Study director, Päijänne Tavastia Central HospitalMari K Salmivuori, MD, Principal investigator, Päijänne Tavastia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367547
- Sponsor's protocol ID
- JointAPHSHC
- Other IDs
- 2014-002746-50, 2014
- Status last verified
- Mar 2019
- First submitted
- 31 Jan 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate
- ClinicalTrials.gov ID
- NCT02367547
- Acronym / sponsor ID
- JointAPHSHC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla
- Study start
- Mar 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Feb 2015 (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.
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Detailed description
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hexylaminolevulinate cream | Experimental | Drug: Hexylaminolevulinate cream2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream |
| Aminolevulinic Acid Nano Emulsion | Experimental | Drug: Aminolevulinic Acid Nano Emulsion78 mg/g Aminolevulinic Acid Nano Emulsion |
| Methylaminolevulinate cream | Active comparator | Drug: Methylaminolevulinate cream160 mg/g Methylaminolevulinate cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- superficial basal cell carcinomas on body area (clinically assessed to be mainly superficially growing and later on a biopsy proven sBCC or thin nBCC)
- lesions accepted needs to be 10 cm apart from each other
Key exclusion criteria (6 listed)
- pigmented, morpheaform, infiltrative or nodular basal cell carcinomas
- lesions that are in face and scalp area
- pregnancy
- breast feeding
- allergy to photosensitizer
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 |
|---|---|---|
| Hexylaminolevulinate creamAlso: HAL, Hexvix, PhotocureThe cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry. | Drug | Hexylaminolevulinate cream |
| Aminolevulinic Acid Nano EmulsionAlso: Ameluz, Biofrontera, L01XD04, BF-200 ALAIn the study we use Ameluz. | Drug | Aminolevulinic Acid Nano Emulsion |
| Methylaminolevulinate creamAlso: Metvix, Galderma, L01X D03, MALIn the study we use Metvix. | Drug | Methylaminolevulinate cream |
Primary outcome
Histological lesion clearance
Time frame: 3 months
Histological lesion clearance
Time frame: 12 months
Histological lesion clearance
Time frame: 5 years
3 secondary outcomes
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 3 months
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 12 months
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
Mari Grönroos, MD, PhD study director
Päijänne Tavastia Central Hospital
Mari K Salmivuori, MD principal investigator
Päijänne Tavastia 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 Hexylaminolevulinate cream, Aminolevulinic Acid Nano Emulsion and Methylaminolevulinate cream in people with Neoplasms, Basal Cell and Carcinoma, Basal Cell, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. 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?
Results are not available in the source record.
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: 3 months). The study lists 3 primary outcomes in all. 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 28 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.