Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead

Phase 1

• Conditions: Therapeutic area: Not possible to specify; Patients (male or female) =18 years old with scalp and forehead actinic keratoses; MedDRA version: 20.0Level: PTClassification code: 10000614Term: Actinic keratosis Class: 100000004858

• Registration Number: CTIS2023-509931-15-00
• Lead Sponsor: Centre Hospitalier Universitaire De Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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., Patient who, according to the investigator's opinion, are in good general condition (WHO =2)., The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade., Patient able to understand and agree to the study visit schedule and other protocol requirements., Patient able to understand and voluntarily sign an informed consent form., Patient with social insurance., Patient willing to comply with all study procedures and study duration.

Exclusion Criteria

Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification., A defined treatment area, which would be : -On an area other than the scalp and/or forehead. -Within 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma., Previous treatment with Tirbanibulin., 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., Use of the following therapies within 2 weeks prior to the screening visit: -Therapeutic 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. -Therapeutic 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., Allergy to tirbanibulin or any of its components., Any pathology entailing a risk of poor compliance., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified