Actinic KeratosesPhase 4NCT02736760
Daylight-PDT With MAL for AK and Photodamaged Skin
A Phase 4 study testing Daylight photodynamic therapy using Methylaminolevulinate (MAL) and Cryosurgery in people with Actinic Keratoses and Photodamaged Skin, run by University Hospital Regensburg at 4 sites in Germany.
Trial summary
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Actinic Keratoses, Photodamaged Skin
- What is being tested?
- Daylight photodynamic therapy using Methylaminolevulinate (MAL) and Cryosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesGermany
- Study dates
- 3 Mar 2016to 9 Sep 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been signed prior to or at Screening Visit
- Male and female patients with Fitzpatrick skin type I-IV
- Age > 40 years
- Negative pregnancy test in women of childbearing age
- Women in child-bearing age using highly efficient contraceptive methods (<1% failure rate per year)
- Clinical diagnosis of actinic keratosis (AK)
- A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face.
- Glogau Photodamage Classification Type II (moderate) - IV (severe)
Who cannot join
- Diagnosis of porphyria
- Hyperkeratotic or pigmented AK in the face
- Malignant skin tumors in the face or on the capillitium, requiring treatment
- Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
- Pregnancy or lactation
- Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing)
Show all 20Show fewer
- Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream
- Known intolerance to Actinica® lotion
- Photosensitivity
- Suspected lack of compliance (e.g. due to dementia)
- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
- Concomitant UV-phototherapy
- Skin diseases that might interfere with response evaluation of study treatment
- Skin sun sensitivity type V or VI according to Fitzpatrick
- PDT in the face during 6 months preceding study treatment
- Non-permitted medication:
- Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator.
- Systemic treatment with retinoids
- Conditions that might interfere with the ability to understand the study and thus give written informed consent
- Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Hautzentrum Köln
Cologne, 50966
University Hospital Düsseldorf.
Düsseldorf, 40225
Klinikum Vest GmbH Knappschaftskrankenhaus
Recklinghausen, 45657
University hospital Regensburg
Regensburg, Bavaria, 93053
About this study
Official title: Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
Read the detailed description
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL compared to cryosurgery in regard to prophylaxis and treatment of AKs in the face. Patients will be randomly allocated to treatment groups. 5 PDT treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
Before application of the photosensitizer, an organic sunscreen (Actinica® lotion, LSF 50+) without mineral filters will be applied In the entire face.
After an absorption time of approximately 15 minutes and before applying MAL (Metvix®), the surface of the AK lesions will be prepared gently with a curette or a scalpel to remove scales and crusts and roughen the surface of the AK-lesions. This is to facilitate penetration of the cream and light to the AK lesions.
After lesion preparation, MAL (Metvix®) will be uniformly applied on the whole face in a thin layer.
Within 30 min after MAL application the patients go outside and expose themselves for 2 hours to daylight. Daylight-PDT can be performed from March until October, during non-rainy weather with an outdoor temperature of at least 10° Celsius. Daylight exposure must start at least 3 hours before sunset.
At the end of the exposure, residual photosensitizer is washed off and the patients spend the rest of the day indoors.
Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.
- Conditions
- Actinic Keratoses, Photodamaged Skin
- Being tested
- Daylight photodynamic therapy using Methylaminolevulinate (MAL), Cryosurgery
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daylight photodynamic therapy using Methylaminolevulinate (MAL)Drug
Also called Daylight-PDT
In the Daylight photodynamic therapy arm the patients will apply a sunscreen to the whole face which is followed by lesion preparation of AKs. Following this, MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.
5 photodynamic therapy treatment sessions (visits 1-5) will be performed within 18 months.
CryosurgeryProcedure or surgery
In the control group, cryosurgery as standard reference therapy will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.
| Study group | Role | What they receive |
|---|---|---|
| Daylight photodynamic therapy (PDT) | Experimental | One intervention in the daylight photodynamic therapy arm:
Daylight photodynamic therapy using Methylaminolevulinate (MAL) will be performed five times within 18 months (visits 1-5). In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and methylaminolevulinate (MAL) will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. Receives: Drug: Daylight photodynamic therapy using Methylaminolevulinate (MAL) |
| Cryosurgery | Active comparator | In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face. Receives: Procedure: Cryosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).
Newly occured AK lesions are counted at visit 2, visit 3, visit 4, visit 5 and visit 6.
The number of newly occured AK lesions during the study are added up, therefore we included the term "cumulative".
Measured: 24 months after the first treatment
Secondary outcomes (7)
Complete clearance of AKs on lesion basis
completely cleared AK lesions
The first treatment ist performed at day 0 The second treatment is performed 3 months after the first treatment. The third treatment is performed 3 months after the second treatment. The fourth treatment is performed 6 months after the third treatment. The fifth treatment is performed 6 months after the fourth treatment.
Measured: This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Complete clearance of AKs on patient basis
completely cleared AK lesions on patient basis
The first treatment ist performed at day 0 The second treatment is performed 3 months after the first treatment. The third treatment is performed 3 months after the second treatment. The fourth treatment is performed 6 months after the third treatment. The fifth treatment is performed 6 months after the fourth treatment.
Measured: This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Photodamage parameters (fine lines, mottled pigmentation, tactile roughness, teleangiectasias, sallowness and global score for photoaging) will be evaluated on a 5-point scale according to Dover et al.
Photodamage parameters will be evaluated on a 5-point scale according to Dover et al. at all visits during the study
The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)
Measured: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Visual pain score
For evaluation of tolerability of daylight-PDT and cryosurgery, a pain score (VAS) will be assessed and documented.
The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)
Measured: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment
Adverse events
All adverse events and serious adverse events will be adequately documented.
The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)
Measured: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment
Patient satisfaction with cosmetic results
For evaluation of satisfaction with cosmetic results, patients and investigators fill in a standardized rating scale
The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)
Measured: This outcome measure is assessed three months after day 0 and the second treatment and 6 months after the third, fourth and fifth treatment
Skin-related quality of life
For evaluation of skin-related quality of life, study participants fill in the Dermatology Life Quality Index, a 10-item questionnaire for routine clinical use. Patients are asked about the impact of their AK and photodamaged skin and its treatment on their lives. Patients' quality of life is expressed in a single score ranging from 0 (no impact) to 30 (severe impact).
Measured: This outcome measure is assessed at day 0 and 24 months after day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start3 Mar 2016
- Primary completion9 Sep 2018
- Study completion9 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Dr. Sigrid Karrer, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736760
- Sponsor's protocol ID
- Daylight_01
- Status last verified
- Nov 2020
- First submitted
- 11 Mar 2016
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kohl E, Koller M, Zeman F, Szeimies RM, Philipp-Dormston WG, Prager W, Gerber PA, Karrer S. Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study. BMC Dermatol. 2017 Oct 25;17(1):12. doi: 10.1186/s12895-017-0064-7.
PubMed 29070025
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face
- ClinicalTrials.gov ID
- NCT02736760
- Acronym / sponsor ID
- Daylight_01
- Conditions
- Actinic Keratoses, Photodamaged Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 9 Sep 2018 (actual)
- First posted
- 13 Apr 2016 (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 study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
Detailed description
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL compared to cryosurgery in regard to prophylaxis and treatment of AKs in the face. Patients will be randomly allocated to treatment groups. 5 PDT treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
Before application of the photosensitizer, an organic sunscreen (Actinica® lotion, LSF 50+) without mineral filters will be applied In the entire face.
After an absorption time of approximately 15 minutes and before applying MAL (Metvix®), the surface of the AK lesions will be prepared gently with a curette or a scalpel to remove scales and crusts and roughen the surface of the AK-lesions. This is to facilitate penetration of the cream and light to the AK lesions.
After lesion preparation, MAL (Metvix®) will be uniformly applied on the whole face in a thin layer.
Within 30 min after MAL application the patients go outside and expose themselves for 2 hours to daylight. Daylight-PDT can be performed from March until October, during non-rainy weather with an outdoor temperature of at least 10° Celsius. Daylight exposure must start at least 3 hours before sunset.
At the end of the exposure, residual photosensitizer is washed off and the patients spend the rest of the day indoors.
Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daylight photodynamic therapy (PDT) | Experimental | Drug: Daylight photodynamic therapy using Methylaminolevulinate (MAL)One intervention in the daylight photodynamic therapy arm: Daylight photodynamic therapy using Methylaminolevulinate (MAL) will be performed five times within 18 months (visits 1-5). In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and methylaminolevulinate (MAL) will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. |
| Cryosurgery | Active comparator | Procedure: CryosurgeryIn the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent has been signed prior to or at Screening Visit
- Male and female patients with Fitzpatrick skin type I-IV
- Age > 40 years
- Negative pregnancy test in women of childbearing age
- Women in child-bearing age using highly efficient contraceptive methods (<1% failure rate per year)
Key exclusion criteria (20 listed)
- Diagnosis of porphyria
- Hyperkeratotic or pigmented AK in the face
- Malignant skin tumors in the face or on the capillitium, requiring treatment
- Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
- Pregnancy or lactation
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 |
|---|---|---|
| Daylight photodynamic therapy using Methylaminolevulinate (MAL)Also: Daylight-PDTIn the Daylight photodynamic therapy arm the patients will apply a sunscreen to the whole face which is followed by lesion preparation of AKs. Following this, MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. 5 photodynamic therapy treatment sessions (visits 1-5) will be performed within 18 months. | Drug | Daylight photodynamic therapy (PDT) |
| CryosurgeryIn the control group, cryosurgery as standard reference therapy will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s. | Procedure or surgery | Cryosurgery |
Primary outcome
The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).
Time frame: 24 months after the first treatment
Newly occured AK lesions are counted at visit 2, visit 3, visit 4, visit 5 and visit 6. The number of newly occured AK lesions during the study are added up, therefore we included the term "cumulative".
7 secondary outcomes
Complete clearance of AKs on lesion basis
Time frame: This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Complete clearance of AKs on patient basis
Time frame: This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Photodamage parameters (fine lines, mottled pigmentation, tactile roughness, teleangiectasias, sallowness and global score for photoaging) will be evaluated on a 5-point scale according to Dover et al.
Time frame: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.
Visual pain score
Time frame: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment
Adverse events
Time frame: This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment
Patient satisfaction with cosmetic results
Time frame: This outcome measure is assessed three months after day 0 and the second treatment and 6 months after the third, fourth and fifth treatment
Skin-related quality of life
Time frame: This outcome measure is assessed at day 0 and 24 months after day 0
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 9 Nov 2020.
- Derived from this study: PubMed 29070025Kohl E, Koller M, Zeman F, Szeimies RM, Philipp-Dormston WG, Prager W, Gerber PA, Karrer S. Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study. BMC Dermatol. 2017 Oct 25;17(1):12. doi: 10.1186/s12895-017-0064-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daylight photodynamic therapy using Methylaminolevulinate (MAL) and Cryosurgery in people with Actinic Keratoses and Photodamaged Skin, run by University Hospital Regensburg at 4 sites in Germany.
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 8 inclusion and 20 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment). (time frame: 24 months after the first treatment). 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 NCT02736760, 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 9 Nov 2020.