E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Thin or non-hyperkeratotic and non-pigmented Actinic Keratosis on the face and scalp |
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E.1.1.1 | Medical condition in easily understood language |
Actinic (solar) Keratosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10020648 |
E.1.2 | Term | Hyperkeratoses |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this trial is to evaluate the subject reported outcome of Luxerm® Daylight field-directed treatment of thin or non-hyperkeratotic and non-pigmented AK lesions on the face or scalp after one session.
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E.2.2 | Secondary objectives of the trial |
Also the efficacy and safety of Luxerm® in terms of subject complete response rate will be assessed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1-Male or female age above 18 years old. 2-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. 3-Subject or caregiver capable of performing the skin preparation and Luxerm treatment application as per the investigator instructions. 4-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). 5-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. 6-Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study. 7-Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed. 8-Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
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E.4 | Principal exclusion criteria |
1-Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area. 2-Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp). 3-Subject with clinical diagnosis of other skin disease on the target anatomical area. 4-Subject with pigmented AK on the target anatomical area. 5-Subject with melanoma at any location. 6-Immunocompromised subject or requiring immunosuppressive therapies. 7-Subject with porphyria; photosensitivity- related disorders, active infectious disease. 8-Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics). 9-Female subject who is pregnant, nursing or planning a pregnancy during the study. 10-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. 11-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 12-Subject who is currently participating to/ or who has participated in another investigational treatment or device research study within 4 weeks of baseline visit. 13-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. 14-Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. 15-Subject who is unwilling to refrain from use of prohibited medication during the clinical trial (see section 4.3.5). 16-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). 17-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. 18-The subject is a study site staff member (investigator, study nurse, etc.) or a relative of one. 19-Subjects with any condition that may be associated with a risk of poor protocol compliance
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject-reported outcomes • Subject questionnaire the day of treatment after daylight session and at last visit (week 12 or early termination)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patient Reported Outcome evaluated at Treatment time and week 12.
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E.5.2 | Secondary end point(s) |
Efficacy endpoints: • Lesion complete response rate, defined as the percentage of preexisting and treated lesions in the anatomical area at baseline assessed as clear at week 12 • Subject complete response rate defined as the percentage of subjects with all treated lesions clear in the anatomical area at Week 12. • Subject partially clear defined as the percentage of subjects with at least 75% lesion complete response in the anatomical area at week 12 • Number of new AK lesions in the anatomical area at week 12 • Clinical assessment of subject’s skin aspect at week12: mean score on anatomical area at week12
Safety variable • Subject’s self-assessment of maximal pain using a 11-point Numeric Rating Scale (NRS) from 0 (no pain) to 10 (extreme pain) after the treatment session • Incidence and severity of adverse events
Other variables • Photodamage score with Dover’s scale at baseline visit and week 12 • Physician questionnaire once all subjects from a site have completed the study.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy endpoints evaluated at week 12. Safety endpoints evaluated throughout the study . Other endpoints evaluated at Baseline and Week 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |