Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead

NCT ID: NCT07273656

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-11-30

Brief Summary

The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.

Conditions

Keratosis; Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Cryotherapy + Tirbanibulin : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Group Type: EXPERIMENTAL

Cryotherapy + Tirbanibulin

Intervention Type: DRUG

Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Control group

Cryotherapy + placebo : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Group Type: PLACEBO_COMPARATOR

Cryotherapy + Tirbanibulin

Intervention Type: DRUG

Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Interventions

Cryotherapy + Tirbanibulin

Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)

Intervention Type: DRUG

Other Intervention Names

Cryotherapy + placebo

Eligibility Criteria

Inclusion Criteria

• Subject over 18 years old presenting with ≥ 8 typical actinic keratoses (AK), clinically visible or palpable, grade I or II, with at least 4 AK per hemiscalp,
• Participants who, in the investigator's judgment, are in good general condition (ECOG ≤ 2),
• The AK must be distributed in 2 non-overlapping areas, and of similar grades,
• Patient capable of understanding and adhering to the study visit schedule and other protocol requirements,
• Patient capable of understanding and voluntarily signing informed consent,
• Patient covered by social insurance,
• Patient willing to comply with all study procedures and duration,
• Women of childbearing potential must:

Have a negative pregnancy test at screening and during the treatment period,

Use an effective contraceptive method throughout the study participation. Menopausal women (absence of menstruation for at least one year without other medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) may be enrolled.

Exclusion Criteria

• Clinically atypical and/or rapidly evolving actinic keratoses (AK) in the treatment area, and grade 3 AK according to Olsen classification,
• A defined treatment area that would be:

1. Located somewhere other than the scalp and/or forehead,

2. Within 5 cm of a wound that is not fully healed or a lesion suspicious for carcinoma,

• Prior treatment with tirbanibulin,
• Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for actinic keratoses in the treatment area or within 2 cm around this area within 6 weeks prior to the screening visit,
• Use of the following therapies within 2 weeks prior to the screening visit:

1. Therapeutic or cosmetic procedures (e.g., liquid nitrogen application, surgical excision, dermabrasion, medium or deep chemical peeling, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area,

2. Therapeutic products containing acids (e.g., salicylic acid, fruit acids), 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 condition causing a risk of poor compliance,
• Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form,
• Women of childbearing potential who refuse to use an effective contraceptive method,
• Pregnant women, women planning to become pregnant, and breastfeeding women,
• Persons deprived of liberty by judicial or administrative decision.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, SAS

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2023_0127

Identifier Type: -

Identifier Source: org_study_id