KeratosisPhase 3TIRBACRYONCT07273656
Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead
A Phase 3 study testing Cryotherapy + Tirbanibulin in people with Keratosis and Actinic Keratoses, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic Keratoses
- What is being tested?
- Cryotherapy + Tirbanibulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
About this study
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
- Being tested
- Cryotherapy + Tirbanibulin
- Keywords
- Tirbanibulin, Cryotherapy, Squamus cell carcinoma, Skin carcinoma, Actinic Keratosis, Field cancerization
- Medical subject headings
- Keratosis, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy + TirbanibulinDrug
Also called Cryotherapy + placebo
Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Cryotherapy + Tirbanibulin : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) Receives: Drug: Cryotherapy + Tirbanibulin |
| Control group | Placebo comparator | Cryotherapy + placebo : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) Receives: Drug: Cryotherapy + Tirbanibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance of actinic keratosis
Complete clearance rate of actinic keratoses at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
Measured: 8 months
Secondary outcomes (5)
To determine the 12-month effectiveness of a combined approach using cryotherapy and tirbanibulin.
Complete Clearance of Actinic Keratosis at 12 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
Measured: 12 months
To evaluate the reduction in the number of actinic keratoses after 2 treatment cycles.
Partial clearance rate (75% reduction in the number of actinic keratoses) at 8 months.
Measured: 8 months
To evaluate the reduction in the number of actinic keratoses after 3 treatment cycles.
Partial clearance rate (75% reduction in the number of actinic keratoses) at 12 months.
Measured: 12 months
To evaluate the reduction in the need for cryotherapy with tirbanibulin.
Number of cryotherapy sessions performed over the entire follow-up period.
Measured: 12 months
To describe the safety and tolerability by treated side at each follow-up visit.
Safety: Local skin reactions assessed throughout the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- One single group, each patient serving as their own control, with an intra-individual comparison of one hemiscalp with the contralateral hemiscalp
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Almirall, SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273656
- Sponsor's protocol ID
- 2023_0127
- Acronym
- TIRBACRYO
- Status last verified
- May 2026
- First submitted
- 23 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead
- ClinicalTrials.gov ID
- NCT07273656
- Acronym / sponsor ID
- TIRBACRYO / 2023_0127
- Conditions
- Keratosis, Actinic Keratoses
- Keywords
- Tirbanibulin, Cryotherapy, Squamus cell carcinoma, Skin carcinoma, Actinic Keratosis, Field cancerization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Almirall, SAS
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One single group, each patient serving as their own control, with an intra-individual comparison of one hemiscalp with the contralateral hemiscalp
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Cryotherapy + TirbanibulinCryotherapy + Tirbanibulin : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) |
| Control group | Placebo comparator | Drug: Cryotherapy + TirbanibulinCryotherapy + placebo : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (15 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy + TirbanibulinAlso: Cryotherapy + placeboTirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) | Drug | Control group, Experimental group |
Primary outcome
Complete clearance of actinic keratosis
Time frame: 8 months
Complete clearance rate of actinic keratoses at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cryotherapy + Tirbanibulin in people with Keratosis and Actinic Keratoses, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance of actinic keratosis (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.