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Freeze then ointment: new combo tackles precancerous skin spots

NCT ID NCT07273656

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether freezing precancerous skin spots (cryotherapy) followed by a medicated ointment (tirbanibulin) works better than freezing alone for actinic keratosis on the scalp and forehead. About 59 adults with at least 8 spots will receive the combo treatment or a placebo ointment after freezing, repeated every 4 months. The main goal is to see if all spots clear up at 8 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirbanibulin ointment
What this could lead to
If successful, this combination treatment could offer a more effective way to clear actinic keratosis lesions on the scalp and forehead, reducing the need for repeated procedures.
What could go wrong
This is a small Phase 3 trial (59 participants) and results may not apply to everyone. The treatment involves multiple cycles and side effects from cryotherapy or the ointment are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 59 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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