Photodynamic TherapyPhase 4NCT01756313
Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
A Phase 4 study testing Laser+Methylaminolevulinat in people with Photodynamic Therapy and Ablative Fractional Laser, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin: 1. Increases the uptake of Methylaminolevulinat (MAL) in the skin. 2. Decreases the required incubation time of MAL when performing photo dynamic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Photodynamic Therapy, Ablative Fractional Laser
- What is being tested?
- Laser+Methylaminolevulinat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- >18 years old
- Fitzpatrick skin type I-III
- No UV exposure thee months prior to study
- Signed study consent
Who cannot join
- Known allergy to substances in MAL or Unguentum M cream.
- Previous keloid
- Use of topical or systemic photosensitizing drug
- Evaluated to not be able to follow treatment protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology, Bispebjerg Hospital
Copenhagen, DK-2400
About this study
The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:
- Increases the uptake of Methylaminolevulinat (MAL) in the skin.
- Decreases the required incubation time of MAL when performing photo dynamic therapy.
Read the detailed description
12 healthy male individuals were included.
On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.
- Density of laser channels. 2) Methylaminolevulinat (MAL) concentration
- Laser - Each area was randomized to receiving:
- no treatment
- 1% laser channel density
- 2% laser channel density
- 5% laser channel density
- 10% laser channel density
- 15% laser channel density
- MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:
- vehicle
- 4% MAL
- 8%MAL
- 16%MAL
The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=
- 0min
- 30min
- 1h
- 1.5h 2h 2.5h 3h
- Conditions
- Photodynamic Therapy, Ablative Fractional Laser
- Being tested
- Laser+Methylaminolevulinat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser+MethylaminolevulinatProcedure or surgery
It's a single arm study. Intervention as described in detailed description.
| Study group | Role | What they receive |
|---|---|---|
| Laser+Methylaminolevulinat | Experimental | It's a single arm. Intervention as described in the detailed description. Receives: Procedure: Laser+Methylaminolevulinat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence Intensity
Fluorescence Intensity measured with a fluorescence camera.
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodynamic TherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Haak, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756313
- Sponsor's protocol ID
- H-4-2012-041
- Status last verified
- Jul 2015
- First submitted
- 20 Dec 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
- ClinicalTrials.gov ID
- NCT01756313
- Acronym / sponsor ID
- H-4-2012-041
- Conditions
- Photodynamic Therapy, Ablative Fractional Laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Dec 2012 (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.
The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:
- Increases the uptake of Methylaminolevulinat (MAL) in the skin.
- Decreases the required incubation time of MAL when performing photo dynamic therapy.
Detailed description
12 healthy male individuals were included.
On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.
- Density of laser channels. 2) Methylaminolevulinat (MAL) concentration
- Laser - Each area was randomized to receiving:
- no treatment
- 1% laser channel density
- 2% laser channel density
- 5% laser channel density
- 10% laser channel density
- 15% laser channel density
- MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:
- vehicle
- 4% MAL
- 8%MAL
- 16%MAL
The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=
- 0min
- 30min
- 1h
- 1.5h 2h 2.5h 3h
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser+Methylaminolevulinat | Experimental | Procedure: Laser+MethylaminolevulinatIt's a single arm. Intervention as described in the detailed description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- >18 years old
- Fitzpatrick skin type I-III
- No UV exposure thee months prior to study
- Signed study consent
Key exclusion criteria (4 listed)
- Known allergy to substances in MAL or Unguentum M cream.
- Previous keloid
- Use of topical or systemic photosensitizing drug
- Evaluated to not be able to follow treatment protocol
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 |
|---|---|---|
| Laser+MethylaminolevulinatIt's a single arm study. Intervention as described in detailed description. | Procedure or surgery | Laser+Methylaminolevulinat |
Primary outcome
Fluorescence Intensity
Time frame: up to 3 hours
Fluorescence Intensity measured with a fluorescence camera.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Related trials for Photodynamic Therapy
Not yet recruitingPhase 2
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Abscess
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
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.
Merete Haedersdal, MD PhD principal investigator
Bispebjerg Hospital
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 Laser+Methylaminolevulinat in people with Photodynamic Therapy and Ablative Fractional Laser, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 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 28 Jul 2015. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fluorescence Intensity (time frame: up to 3 hours). 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 Jul 2015.