Actinic KeratosesPhase 4SESAME 2NCT03511326
PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK
A Phase 4 study testing Methyl Aminolaevulinate 16% Cream in people with Actinic Keratoses, run by Galderma R&D at 1 site in Germany.
Trial summary
Interventional open label prospective and multicentre study conducted in Germany in subjects with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding scalp, using Luxerm® DL-PDT treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Methyl Aminolaevulinate 16% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jun 2017to 28 Nov 2017
- Phase
- Phase 4
- 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
- Male or female age > 18 years old.
- Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
- Subject or caregiver capable of performing the skin preparation and Luxerm® treatment application as per the investigator instructions.
- Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
- Female subject of non-childbearing potential, e.g.: post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
- Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
- Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
- Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
Who cannot join
- Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
- Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
- Subject with clinical diagnosis of other skin disease on the target anatomical area.
- Subject with pigmented AK on the target anatomical area.
- Subject with melanoma at any location.
- Immunocompromised subject or requiring immunosuppressive therapies.
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- Subject with porphyria; photosensitivity- related disorders, active infectious disease.
- Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
- Female subject who is pregnant, nursing or planning a pregnancy during the study.
- Subject who has used any of the following topical preparations on the area to be treated: keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- Subject with a wash-out period from baseline for topical or systemic treatment or medical/surgical procedure in the anatomical area (for AKs) less than the following:
- Retinoids, including tazarotene, adapalene, tretinoin, retinol ==> 4 weeks
- Cryotherapy, diclofenac, corticosteroids or other treatments for AK==> 8 weeks
- Microdermabrasion, laser ablative treatments or chemical peels ==>8 weeks
- 5-FU, imiquimod ==>24 weeks
- Surgical: excision and reconstructive surgery, chemosurgery, ==>12 weeks
- Any Photodynamic Therapy, ingenol mebutate (Pep-005), Radiotherapy and UV radiation therapy==>12 weeks
- Investigational therapies for Actinic Keratoses==>12 weeks
- Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on interferon, opioids, TNF binding proteins, Mycophenolate, small biologics agents)==>12 weeks
- Subject who is currently participating to/ or who has participated in another investigational treatment or device research study within 4 weeks of baseline visit.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject who is unwilling to refrain from use of prohibited medication during the clinical trial (see section 4.3.5).
- Subject who is vulnerable (such as deprived of freedom) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
- Subject with clinically significant abnormal laboratory finding (if any available report) at the baseline visit or medical/surgical condition (other than for actinic keratoses), which might, in the Investigator's opinion, interfere with study evaluations or pose a risk to subject safety during the study.
- The subject is a study site staff member (investigator, study nurse, etc.) or a relative of one.
- Subjects with any condition that may be associated with a risk of poor protocol compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp
Interventional open label prospective and multicentre study conducted in Germany in subjects with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding scalp, using Luxerm® DL-PDT treatment.
- Conditions
- Actinic Keratoses
- Being tested
- Methyl Aminolaevulinate 16% Cream
- Keywords
- field-treatment
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Aminolaevulinate 16% CreamDrug
Also called 160mg/g of methyl aminolevulinate
Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Luxerm® | Experimental | Not described Receives: Drug: Methyl Aminolaevulinate 16% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Subject Satisfaction the Day of Treatment After Daylight Session
Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session
Measured: the day of treatment after daylight session
Overall Subject Satisfaction at Week 12 Post-treatment
Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start7 Jun 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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 KeratosesStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajeev CHAVDA, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511326
- Sponsor's protocol ID
- RD.03.SPR.114384
- Acronym
- SESAME 2
- Status last verified
- Sep 2018
- First submitted
- 25 Aug 2017
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp
- ClinicalTrials.gov ID
- NCT03511326
- Acronym / sponsor ID
- SESAME 2 / RD.03.SPR.114384
- Conditions
- Actinic Keratoses
- Keywords
- field-treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional open label prospective and multicentre study conducted in Germany in subjects with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding scalp, using Luxerm® DL-PDT treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luxerm® | Experimental | Drug: Methyl Aminolaevulinate 16% Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age > 18 years old.
- Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
- Subject or caregiver capable of performing the skin preparation and Luxerm® treatment application as per the investigator instructions.
- Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
- Female subject of non-childbearing potential, e.g.: post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
Key exclusion criteria (27 listed)
- Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
- Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
- Subject with clinical diagnosis of other skin disease on the target anatomical area.
- Subject with pigmented AK on the target anatomical area.
- Subject with melanoma at any location.
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 |
|---|---|---|
| Methyl Aminolaevulinate 16% CreamAlso: 160mg/g of methyl aminolevulinateSubject will received one session of methyl aminolevulinate Daylight Photodynamic therapy | Drug | Luxerm® |
Primary outcome
Overall Subject Satisfaction the Day of Treatment After Daylight Session
Time frame: the day of treatment after daylight session
Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session
Overall Subject Satisfaction at Week 12 Post-treatment
Time frame: Week 12
Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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.
Rajeev CHAVDA, MD study director
Galderma R&D
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 Methyl Aminolaevulinate 16% Cream in people with Actinic Keratoses, run by Galderma R&D at 1 site 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 27 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 Feb 2021. 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 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?
Yes. Results are posted in the registry (first posted 10 Dec 2020). 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?
Overall Subject Satisfaction the Day of Treatment After Daylight Session (time frame: the day of treatment after daylight session). The study lists 2 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 Feb 2021.