Tirbanibulin for Actinic keratosis

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 years old with Scalp containing ≥ 8 typical, clinically visible or palpable grade I or II actinic keratosis with at least 4 actinic keratosis per hemi-scalp."}
• {"criterion_text":"- Patient who, according to the investigator's opinion, are in good general condition (WHO ≤2)."}
• {"criterion_text":"- The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade."}
• {"criterion_text":"- Patient able to understand and agree to the study visit schedule and other protocol requirements."}
• {"criterion_text":"- Patient able to understand and voluntarily sign an informed consent form."}
• {"criterion_text":"- Patient with social insurance."}
• {"criterion_text":"- Patient willing to comply with all study procedures and study duration."}

Exclusion criteria

• {"criterion_text":"- Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification."}
• {"criterion_text":"- A defined treatment area, which would be : -\tOn an area other than the scalp and/or forehead. -\tWithin 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma."}
• {"criterion_text":"- Previous treatment with Tirbanibulin."}
• {"criterion_text":"- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatment for actinic keratosis in the treatment area, or within 2 cm around this area, in the 6 weeks prior to the screening visit."}
• {"criterion_text":"- Use of the following therapies within 2 weeks prior to the screening visit: -\tTherapeutic or cosmetic procedures (e.g. use of liquid nitrogen, surgical excision, dermabrasion, medium or deep chemical peel, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area. -\tTherapeutic products containing acid (e.g. salicylic acid, fruit acids, etc.), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area."}
• {"criterion_text":"- Allergy to tirbanibulin or any of its components."}
• {"criterion_text":"- Any pathology entailing a risk of poor compliance."}
• {"criterion_text":"- Administrative reasons: inability to receive informed information, inability to take part in the entire study, lack of social security cover, refusal to sign consent, etc."}

Primary endpoints

• {"endpoint_text":"- Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.","definition_or_measurement_approach":"A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area (assessment at 8 months)."}

Secondary endpoints

• {"endpoint_text":"- Complete response rate for actinic keratosis at 12 months.","definition_or_measurement_approach":"Assessment of complete response at 12 months (absence of clinically detectable actinic keratosis)."}
• {"endpoint_text":"- Partial response rate (= 75% reduction of lesions) at 8 months.","definition_or_measurement_approach":"Partial response defined as ≥75% reduction of lesions, assessed at 8 months."}
• {"endpoint_text":"- Partial response rate (= 75% reduction of lesions) at 12 months.","definition_or_measurement_approach":"Partial response defined as ≥75% reduction of lesions, assessed at 12 months."}
• {"endpoint_text":"- Number of cryotherapy sessions carried out over the follow-up period.","definition_or_measurement_approach":"Count of cryotherapy sessions during follow-up."}
• {"endpoint_text":"- Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10.","definition_or_measurement_approach":"Local skin reactions graded 0–3 as specified; pain assessed by visual analogue scale 0–10."}
• {"endpoint_text":"- The photographs taken during the visits will be analysed using computer-aided image processing.","definition_or_measurement_approach":"Photographs analyzed using computer-aided image processing methods."}

France

Earliest CTIS Part Ii Submission Date

27-05-2024

Latest Decision Or Authorization Date

28-06-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

59

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Lille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"ALMIRALL","duties_or_roles":"Monetary support (listed as source of monetary support); listed as product manufacturer/supplier in product information.","organisation_type":""}