Actinic KeratosesPhase 4NCT06026358
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
A Phase 4 study testing Tirbanibulin in people with Actinic Keratoses, run by Medical University of Graz.
Trial summary
Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Tirbanibulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Informed consent
- Diagnosed with AK on both hands
- 4-8 AK lesions on each hand, difference in number of lesions < 20%
- Grade of lesions comparable in both hands: non hypertrophic, non-hyperkeratotic
- Willing and able to comply with all study procedures
- Use of medically acceptable contraception (both sexes)
- 18 - 99 years of age.
Who cannot join
- o History of sensitivity and/or allergy to any of the ingredients in the study medication.
- Open lesions of any kind on the hands
- Concomitant cutaneous malignancy in treatment area
- Immune deficiency
- Participation in another clinical trial during the last 6 months
- Had been previously treated with Tirbanibulin
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- Anticipated need for in-patient hospitalisation or in-patient surgery from Day 1 to Day 57.
- Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area within 8 weeks prior to the Screening Visit.
- Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
- Cosmetic or therapeutic procedures (eg, use of liquid nitro-gen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treat-ment area
- Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and gly-colic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treat-ment area
- Topical salves (nonmedicated/nonirritant lotion and cream were acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artifi-cial tanners within the treatment area or within 5 cm of the selected treatment area.
- Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit:
- Treatment with immunomodulators (eg, azathioprine), cy-totoxic drugs (e.g., cyclophosphamide, vinblastine, chlo-rambucil, methotrexate) or interferons/interferon induc-ers.
- Treatment with systemic medications that suppress the im-mune system (e.g., cyclosporine, prednisone, methotrex-ate, alefacept, infliximab).
- Use of systemic retinoids (e.g., isotretinoin, acitretin, bexaro-tene) within 6 months prior to the Screening Visit.
- Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or con-dition (e.g., scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evalu-ations, or which exposed the subject to unacceptable risk by study participation.
- Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would have exposed the subject to unacceptable risk by study participa-tion.
- Pregnancy or lactation
- Excessive exposure to UV radiation during study period.
About this study
Official title: Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study
Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.
- Conditions
- Actinic Keratoses
- Being tested
- Tirbanibulin
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirbanibulinDrug
subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.
| Study group | Role | What they receive |
|---|---|---|
| Tirbanibulin | Experimental | Treatment Receives: Drug: Tirbanibulin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Tirbanibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial clearance at day 57 ± 7 after start of blinded treatment
Measured: day 57 ± 7 after start of blinded treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: lack of ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Almirall, SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026358
- Sponsor's protocol ID
- Tirbanibulin: Back of Hands
- Status last verified
- May 2024
- First submitted
- 30 Aug 2023
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06026358
- Acronym / sponsor ID
- Tirbanibulin: Back of Hands
- Conditions
- Actinic Keratoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Almirall, SAS
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Sep 2023 (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.
Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirbanibulin | Experimental | Drug: TirbanibulinTreatment |
| Placebo | Placebo comparator | Drug: TirbanibulinPlacebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- o Informed consent
Key exclusion criteria (20 listed)
- o History of sensitivity and/or allergy to any of the ingredients in the study medication.
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 |
|---|---|---|
| Tirbanibulinsubjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner. | Drug | Placebo, Tirbanibulin |
Primary outcome
Partial clearance at day 57 ± 7 after start of blinded treatment
Time frame: day 57 ± 7 after start of blinded treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- 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. This study is not recruiting at the moment.
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 4 study testing Tirbanibulin in people with Actinic Keratoses, run by Medical University of Graz.
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 7 inclusion and 20 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: withdrawn, as of the sponsor's last update on 30 May 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Partial clearance at day 57 ± 7 after start of blinded treatment (time frame: day 57 ± 7 after start of blinded treatment). 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 30 May 2024.