Actinic KeratosisPhase 3NCT00472459
Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer
A Phase 3 study testing Photodynamic therapy with Metvix 160 mg/g cream in people with Actinic Keratosis and Warts, run by Galderma R&D at 11 sites in 5 countries.
Trial summary
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis, Warts, Basal Cell Carcinoma
- What is being tested?
- Photodynamic therapy with Metvix 160 mg/g cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 25 Jul 2003to 14 Jul 2006
- Phase
- Phase 3
- 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
- Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10^2 cm) in the face, the scalp, the extremities or on the trunk/neck.
- Transplant recipients who previously were treated more than once for their skin lesions.
- Transplant recipients who had received immunosuppressive therapy for more than 3 years.
- Males or females above 18 years of age.
- Written informed consent.
Who cannot join
- Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.
- Participants with SCC (not SCC in situ) in one of the two areas.
- Participants not previously treated or treated only once for their skin lesions.
- Participants with rosacea in one of the two areas.
- Participants with morphea form/highly infiltrating BCC
- Known allergy to methyl-amino levulinate, a similar compound or excipients of the cream
Show all 9Show fewer
- Participation in other clinical studies either concurrently or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter).
- Conditions associated with a risk of poor protocol compliance
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Sweden3 sites
Department of Dermatology, Sahlgrenska University Hospital
Gothenburg, 41345
Department of Dermatology, Karolinska University Hospital, Huddinge
Stockholm, 14186
Department of Dermatology, Uppsala University Hospital
Uppsala, 75185
Denmark2 sites
Department of Dermatology, Århus Amysygehus
Aarhus, 8000
Department of Dermatology, Roskilde Amysygehus
Roskilde, 4000
Germany2 sites
Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte
Berlin, 10117
Hautklinik Linden
Hanover, 30449
Norway2 sites
Department of Dermatology, Rikshospitalet
Oslo, 0027
Department of Dermatology, St. Olavs Hospital
Trondheim, 7006
United Kingdom2 sites
Dermatology Department, Manchester Royal Infirmary
Manchester, M13 9WL
Portsmouth Dermatology Centre, St Mary's Hospital
Portsmouth, PO3 6AD
About this study
Official title: A Multicenter, Randomized Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period.
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions.
In this study, two contralateral areas (5x10 cm^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
Read the detailed description
The treatment area (5x10 cm^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and lesions with no response were treated with lesion specific treatment at the discretion of the investigator.
In the contralateral control area (5x10 cm^2), new and recurrent lesions and lesions in non-complete response were treated with lesion specific treatment at the discretion of the investigator at each study visit.
- Being tested
- Photodynamic therapy with Metvix 160 mg/g cream
- Keywords
- Non-melanoma skin cancer, Organ transplant recipients, Photodynamic therapy, Actinic keratosis
- Medical subject headings
- Keratosis, Actinic, Warts, Carcinoma, Basal Cell, Bowen's Disease, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy with Metvix 160 mg/g creamProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Metvix®-PDT (Treatment Area +Contralateral Control Area) | Experimental | Two contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, that is (i.e.), treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 milligrams/gram (mg/g) cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. The contralateral control area was treated using lesion-specific treatment in accordance with the Investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. Receives: Procedure: Photodynamic therapy with Metvix 160 mg/g cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Accumulated New Skin Lesions at Month 3
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.
Measured: At Month 3
Number of Accumulated New Skin Lesions at Month 9
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.
Measured: At Month 9
Number of Accumulated New Skin Lesions at Month 15
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.
Measured: At Month 15
Number of Accumulated New Skin Lesions at Month 21
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.
Measured: At Month 21
Number of Accumulated New Skin Lesions at Month 27
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.
Measured: At Month 27
Number of AK Lesions That Showed Complete Response at Month 3
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Measured: At Month 3
Number of AK Lesions That Showed Complete Response at Month 9
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Measured: At Month 9
Number of AK Lesions That Showed Complete Response at Month 15
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Measured: At Month 15
Number of AK Lesions That Showed Complete Response at Month 21
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Measured: At Month 21
Number of AK Lesions That Showed Complete Response at Month 27
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Measured: At Month 27
Secondary outcomes (4)
Number of BCC Lesions That Showed Complete Response
Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported.
Measured: At Months 3, 9, 15, 21 and 27
Number of Recurrent Lesions
Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice.
Measured: At Months 9, 15, 21 and 27
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants
Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect).
Measured: At Month 27
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: From Baseline up to Month 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study start25 Jul 2003
- Primary completion23 Sep 2004
- Study completion14 Jul 2006
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 KeratosisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann-Marie Wennberg, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472459
- Sponsor's protocol ID
- PC T313/03
- Status last verified
- Mar 2025
- First submitted
- 10 May 2007
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer
- ClinicalTrials.gov ID
- NCT00472459
- Acronym / sponsor ID
- PC T313/03
- Keywords
- Non-melanoma skin cancer, Organ transplant recipients, Photodynamic therapy, Actinic keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2003 (actual)
- Primary completion
- 23 Sep 2004 (actual)
- Study completion
- 14 Jul 2006 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period.
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions.
In this study, two contralateral areas (5x10 cm^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
Detailed description
The treatment area (5x10 cm^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and lesions with no response were treated with lesion specific treatment at the discretion of the investigator.
In the contralateral control area (5x10 cm^2), new and recurrent lesions and lesions in non-complete response were treated with lesion specific treatment at the discretion of the investigator at each study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metvix®-PDT (Treatment Area +Contralateral Control Area) | Experimental | Procedure: Photodynamic therapy with Metvix 160 mg/g creamTwo contralateral areas (symmetrically) were identified with an area of 5*10-centimeter square, that is (i.e.), treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 milligrams/gram (mg/g) cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. The contralateral control area was treated using lesion-specific treatment in accordance with the Investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10^2 cm) in the face, the scalp, the extremities or on the trunk/neck.
- Transplant recipients who previously were treated more than once for their skin lesions.
- Transplant recipients who had received immunosuppressive therapy for more than 3 years.
- Males or females above 18 years of age.
- Written informed consent.
Key exclusion criteria (9 listed)
- Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.
- Participants with SCC (not SCC in situ) in one of the two areas.
- Participants not previously treated or treated only once for their skin lesions.
- Participants with rosacea in one of the two areas.
- Participants with morphea form/highly infiltrating BCC
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 |
|---|---|---|
| Photodynamic therapy with Metvix 160 mg/g cream | Procedure or surgery | Metvix®-PDT (Treatment Area +Contralateral Control Area) |
Primary outcome
Number of Accumulated New Skin Lesions at Month 3
Time frame: At Month 3
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.
Number of Accumulated New Skin Lesions at Month 9
Time frame: At Month 9
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.
Number of Accumulated New Skin Lesions at Month 15
Time frame: At Month 15
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.
Number of Accumulated New Skin Lesions at Month 21
Time frame: At Month 21
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.
Number of Accumulated New Skin Lesions at Month 27
Time frame: At Month 27
A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.
Number of AK Lesions That Showed Complete Response at Month 3
Time frame: At Month 3
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 9
Time frame: At Month 9
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 15
Time frame: At Month 15
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 21
Time frame: At Month 21
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
Number of AK Lesions That Showed Complete Response at Month 27
Time frame: At Month 27
Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.
4 secondary outcomes
Number of BCC Lesions That Showed Complete Response
Time frame: At Months 3, 9, 15, 21 and 27
Number of Recurrent Lesions
Time frame: At Months 9, 15, 21 and 27
Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants
Time frame: At Month 27
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline up to Month 27
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ann-Marie Wennberg, MD, PhD principal investigator
Sahlgrenska University Hospital
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photodynamic therapy with Metvix 160 mg/g cream in people with Actinic Keratosis and Warts, run by Galderma R&D at 11 sites in 5 countries.
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 9 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden, Denmark, Germany, Norway, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Apr 2025). 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?
Number of Accumulated New Skin Lesions at Month 3 (time frame: At Month 3). The study lists 10 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 18 Apr 2025.