Actinic keratosis with 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
Conditions
Interventions
Trade Name: Tolak 40 mg/g Creme
Pharmaceutical Form: Cream
INN or Proposed INN: Fluorouracil
Other descriptive name: FLUOROURACIL
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
C
Sponsors
Pierre Fabre Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible only if all of the following criteria apply: Age 1. Participant must be more than 18 years old inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Individuals with a clinical diagnosis of actinic keratosis (AK). 3. Individuals harboring 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The AK lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic. 4. Subject in good general condition and free of any disease state or condition which, in the investigator's opinion, could impair evaluation of actinic keratosis or could expose the subject to an unacceptable risk by study participation. Sex 5. Male or female. A Female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP), defined as postmenopausal (cessation of menses >12 months) or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, total hysterectomy). Informed Consent 6. Capable of giving signed informed consent as described in Appendix 1: Regulatory, Ethical, and Study Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Ethical/Legal considerations 7. Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. With AK lesions within treatment areas which are hyperkeratotic or which are clinically suspected to be squamous cell carcinoma (SCC). 2. With pre-existing local skin reactions with a total score = 3. 3. History of hypersensitivity to the ingredients of Tolak® or Dexeryl®. 4. With a known allergy to peanut or soya. 5. Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeading women. Prior/Concomitant Therapy 6. Under systemic 5-fluorouracil or any systemic cancer treatment within eight weeks prior to the study. 7. Under any other topical AK treatments or therapies (e.g., Cryotherapy or Photodynamic therapy) in the treatment area(s) within eight weeks prior to starting the study. 8. Treated with systemic steroids, immunosuppressants or immunomodulators within four weeks prior to the study. 9. Under prescription retinoids or topical steroids in the treatment area(s) within four weeks prior to the study. 10. With known dihydropyrimidinedehydrogénase (DPD) deficiency or under treatment with brivudine, sorivudine or analogues within 4 weeks prior to starting the study. 11. Treated with glycolic acid products and alpha-hydroxy products in the treatment area(s) within four weeks prior to starting the study. 12. Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study. Prior/Concurrent Clinical Study Experience 13. Is participating in another clinical trial 14. Has participated in another clinical trial within the last 30 days, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial Other Exclusions 15. Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…) 16. Is in a position likely to represent a conflict of interest 17. Has forfeited his / her freedom by administrative or legal award or is under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study objective is to assess the frequency and the intensity of the local skin reactions at the end of the treatment course (or before in case of patient withdrawal).;Secondary Objective: The other objectives are to evaluate the drop-outs due to AEs related to local skin reactions, the general safety and the clinical efficacy by the investigator. Patients will evaluate the treatment satisfaction (acceptability), the treatment adherence and the health-related quality of life during the treatment. ;Primary end point(s): The primary endpoint in this trial is the Local Skin Reaction (LSR) total score ;Timepoint(s) of evaluation of this end point: at W4, or at an optional visit (LOCF) in case of major local reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes will be the following: Tolerability: • Local skin reactions: LSR total score at week 2 and Weekweek 8; • LSR items alone at each visit (see below): presence/absence and intensity; • Local reactions CTCAE grade 3 or 4. Other safety evaluations: • Other AEs reported by patients or noticed by investigator (see section 8.4 AE and SAE of the protocol); • Drop outs due to AE related to local skin reactions (discontinuation rate); • Use of rescue treatment (TCS). AE will be collected during the whole study period from signature of informed consent up to week 8 (W8) or premature withdrawal. Any clinical findings obtained during the study, will be followed until the condition returns to normal or stabilized. Patient reported outcomes: • Subjective signs at each visit: prurit (0-3), stinging/burning (0-3), pain (0-4); • Treatment satisfaction (acceptability): measured by TSQM-9 (treatment satisfaction questionnaire for medication) at W4 (end of treatment) or Patient Withdrawal (PW); • Treatment adherence: assessed by direct questioning of the participant by the investigatorusing a self questionnaire at W4; and Optional Visit (OV; when applicable); • Health-related quality of life: measured by AKQoL (actinic keratosis quality of life questionnaire, for Spain and Germany only) at baseline and W8 (4 weeks off-treatment and change from baseline). Clinical response (efficacy): measured by • Rates of patients with complete and partial clearance rates (cCR, pCR) at W8 (4 weeks off-treatment); • Change and Percentage change in number of AK lesions from baseline to week 2 (W2), W4 and W8. At each visit, the investigator will count of all visible and/or palpable actinic keratosis lesions in the treatment area(s). ;Timepoint(s) of evaluation of this end point: Detailed in E.5.2 | — |
Countries
France, Germany, Italy, Spain
Contacts
Public ContactNational Coordination center
Katholisches Klinikum Bochum gGmbH
Outcome results
None listed