Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

Pierre Fabre

Status and phase: Completed; Phase 4

Conditions: Actinic Keratoses

Treatments: Device: Dexeryl; Drug: 5-fluorouracil 4% (Tolak)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04875026

W00118 CR 401

2020-000851-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 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).

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 breastfeeding 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

5-fluorouracil 4% (Tolak) + Dexeryl

Experimental group

Description:

This group will apply 5-FU once daily for 4 weeks, and Dexeryl once daily for 8 weeks.

Treatment:

Drug: 5-fluorouracil 4% (Tolak)

Device: Dexeryl

5-fluorouracil 4% (Tolak)

Other group

Description:

This group will only apply 5-FU once daily for 4 weeks.

Treatment:

Drug: 5-fluorouracil 4% (Tolak)