A Phase 4 interventional study of 5-fluorouracil 4% (Tolak) and Dexeryl in Actinic Keratoses, sponsored by Pierre Fabre Medicament. Completed at 27 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-19.
Sponsored by Pierre Fabre Medicament · Phase 4, Interventional, and Supportive care
Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.
The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 146 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are eligible only if all of the following criteria apply:
Age
Participant must be more than 18 years old inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
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
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
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Ethical/Legal considerations
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeeding women.
Prior/Concomitant Therapy
Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study.
Prior/Concurrent Clinical Study Experience
This group will apply 5-FU once daily for 4 weeks, and Dexeryl once daily for 8 weeks.
Drug: 5-fluorouracil 4% (Tolak) · Device: Dexeryl
This group will only apply 5-FU once daily for 4 weeks.
Drug: 5-fluorouracil 4% (Tolak)
Application of Tolak once daily in the evening for 4 weeks
Application of Dexeryl once daily in the morning for 8 weeks
Local Skin Reaction (LSR) total score
Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).
Time frame: at 4 weeks or Last Observation Carried Forward (LOCF)
Local Skin Reaction (LSR) total score
Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).
Time frame: at 2 weeks (first follow-up)
Local Skin Reaction (LSR) total score
Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).
Time frame: at 8 weeks (last follow up)
Local Skin Reaction (LSR) items alone
Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst
Time frame: at 2 weeks (first follow-up)
Local Skin Reaction (LSR) items alone
Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst
Time frame: at 4 weeks (second follow up)
Local Skin Reaction (LSR) items alone
Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst
Time frame: at 8 weeks (last follow up)
Subjective signs at each visit
Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.
Time frame: at 2 weeks (first follow-up)
Subjective signs at each visit
Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.
Time frame: at 4 weeks (second follow up)
Subjective signs at each visit
Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.
Time frame: at 8 weeks (last follow up)
Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4
Intensity grading of adverse events
Time frame: at 2 weeks (first follow-up)
Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4
Intensity grading of adverse events
Time frame: at 4 weeks (second follow up)
Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4
Intensity grading of adverse events
Time frame: at 8 weeks (last follow up)
Adverse Events reported by patients or noticed by investigator
Time frame: at 2, 4 and 8 weeks (first follow-up)
Drop outs due to Adverse Events (AE) related to local skin reaction
discontinuation rate
Time frame: at 2, 4 and 8 weeks (first follow-up)
Use of rescue treatment
Time frame: at 2 weeks (first follow-up)
Use of rescue treatment
Time frame: at 4 weeks (second follow up)
Use of rescue treatment
Time frame: at 8 weeks (last follow up)
Treatment satisfaction (acceptability): measured by Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9)
The TSQM-9 questionnaire includes nine questions that assess patients' satisfaction by providing score on three scales: effectiveness (questions 1 to 3), convenience (questions 4 to 6) and global satisfaction (questions 7 to 9). The scores of each scale range from 0 to 100, where a higher score indicates a greater satisfaction
Time frame: at 4 weeks (end of treatment) or at Patient Withdrawal
Treatment adherence
assessed by the participant using a self questionnaire
Time frame: at 4 weeks
Treatment adherence
assessed by the participant using a self questionnaire
Time frame: at optional visit (when applicable), up to 8 weeks
Health-related quality of life measured by actinic keratosis quality of life questionnaire (AKQoL)
actinic keratosis quality of life patient questionnaire, for Spain and Germany only. 0 is the best outcome, 27 is the worst outcome
Time frame: at 8 weeks (last follow up)
Rates of patients with complete and partial clearance rates
Time frame: at 8 weeks (last follow up)
Rates of patients with partial clearance rates
Time frame: at 8 weeks (last follow up)
Percentage change in number of AK lesions
Time frame: at baseline
Percentage change in number of AK lesions
Time frame: at 2 weeks (first follow-up)
Change in number of AK lesions
Time frame: at 2 weeks (first follow-up)
Percentage change in number of AK lesions
Time frame: at 4 weeks (second follow up)
Change in number of AK lesions
Time frame: at 4 weeks (second follow up)
Percentage change in number of AK lesions
Time frame: at 8 weeks (last follow up)
Change in number of AK lesions
Time frame: at 8 weeks (last follow up)
Plan to share: No
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Pierre Fabre Medicament