Not yet recruiting NCT07273656

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

Phase III Interventional Keratosis Actinic Keratoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Cryotherapy + Tirbanibulin.
Who it may be relevant to: Registry conditions: Keratosis, Actinic Keratoses. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

Complete clearance of actinic keratosis [Time frame: 8 months]

Secondary outcome measures (5)

To determine the 12-month effectiveness of a combined approach using cryotherapy and tirbanibulin. [Time frame: 12 months]
To evaluate the reduction in the number of actinic keratoses after 2 treatment cycles. [Time frame: 8 months]
To evaluate the reduction in the number of actinic keratoses after 3 treatment cycles. [Time frame: 12 months]
To evaluate the reduction in the need for cryotherapy with tirbanibulin. [Time frame: 12 months]
To describe the safety and tolerability by treated side at each follow-up visit. [Time frame: 12 months]

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:

Located somewhere other than the scalp and/or forehead,
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:

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,
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Single group
Masking: Double blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07273656 · 2023_0127

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗