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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luxerm® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Aminolaevulinate 16% Cream | Drug | Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rajeev CHAVDA, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Regensburg | Regensburg | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Luxerm® | Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Luxerm® | Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent to Treat (ITT) population included all enrolled participants (i.e. treatment dispensed). | Posted | Count of Participants | Participants | the day of treatment after daylight session |
|
|
From signing of Informed Consent Form (ICF) to end of study (Week 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Luxerm® | Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CTA Coordinator | Galderma R&D SNC | +33 0493 95 70 85 | cta.coordinator@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2017 | Sep 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skin phototype | Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to III. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly. | Count of Participants | Participants |
|
| Duration of Actinic Keratosis | Mean | Standard Deviation | years |
|
| Participants |
|
|
| Primary | Overall Subject Satisfaction at Week 12 Post-treatment | Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure | ITT population included all enrolled participants (i.e. treatment dispensed). Here, the "N" number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 28 |
| 50 |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |