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Exploratory study to determine the tolerability and effectiveness of Tirbanibulin in the treatment of Actinic Cheilitis - Cheilitis trial
EU CTIS ID: 2022-502807-31-00
What this study is testing
Investigation of the effectiveness of Tirbanibulin (Klisyri) after five-day-application in patients with Actinic Cheilitis (healing) by measuring the reduction of the affected area.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Newly diagnosed Actinic Cheilitis (clinically and by optical coherence tomography) or chronic Actinic Cheilitis at the time of registration (Clinic: atrophy of the lip (white coloration) or adhering , hyperkeratotic plaques or erosions; OCT: thickening of epidermis and increase in signal penetration and intact dermoepidermal junction zone)
- Skin type I to III (Fitzpatrick scale)
- Written informed consent after clarification
You likely can't join if
- Known genetic defect of the epidermal barrier (e.g. Netherton-Syndrome)
- Local enteritis, ulcerative colitis or known antibiotic-associated colitis
- Current or previous invasive squamous cell carcinoma of the respective lip intended for treatment
- Active cancer disease
- Known hypersensitivity towards the medicinal product under investigation or one of its components or towards medications of a similar chemical structure
- Participation in another interventional clinical trial (up to 4 weeks before start of therapy)
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Newly diagnosed Actinic Cheilitis (clinically and by optical coherence tomography) or chronic Actinic Cheilitis at the time of registration (Clinic: atrophy of the lip (white coloration) or adhering , hyperkeratotic plaques or erosions; OCT: thickening of epidermis and increase in signal penetration and intact dermoepidermal junction zone)
- Skin type I to III (Fitzpatrick scale)
- Written informed consent after clarification
What rules you out
- Known genetic defect of the epidermal barrier (e.g. Netherton-Syndrome)
- Local enteritis, ulcerative colitis or known antibiotic-associated colitis
- Current or previous invasive squamous cell carcinoma of the respective lip intended for treatment
- Active cancer disease
- Known hypersensitivity towards the medicinal product under investigation or one of its components or towards medications of a similar chemical structure
- Participation in another interventional clinical trial (up to 4 weeks before start of therapy)
- Addiction or other concomitant diseases, which prevent the participant from understanding and comprehending the scope, nature and potential consequences of this clinical trial
- Pregnant or lactating women
- Male participants with partners of childbearing potential, not meeting at least one of the following criteria: Postmenopausal (12 months of amenorrhea by natural causes, or 6 months of amenorrhea in combination with a highly effective contraception method (Pearl Index <1%)); Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); Negative pregnancy test (urine, minimum sensitivity for Beta-HCG 25mIU/ml) and willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index < 1 %) ((hormonal contraception (estrogen- gestagen combinations), hormonal contraception (progestogen preparations, oral, injected, implant), spiral (hormonal coil, copper IUD), confirmed partner’s vasectomy, abstinence from study incusion unitl final visit ))
- Women of childbearing potential, except for women who meet at least one of the following criteria: Postmenopausal (12 months of amenorrhea by natural causes, or 6 months of amenorrhea in combination with a highly effective contraception method (Pearl Index <1%)); Post-surgery (6 weeks after bilateral ovariectomy, bilateral salpingectomy with or without a hysterectomy); Negative pregnancy test (urine, minimum required sensitivity for Beta-HCG 25mIU/ml Beta-HCG) and willingness to regularly and correctly use a highly effective contraceptive method (Pearl Index < 1 %) ((hormonal contraception (estrogen- gestagen combinations), hormonal contraception (progestogen preparations, oral, injected, implant), spiral (hormonal coil, copper IUD), confirmed sucessfull partner’s vasectomy, abstinence from study inclusion until the final visit))
- Individuals who are unable to give consent
- Signs of facial skin irritation (significant redness, dryness, burning sensation, stabbing sensation, pruritus) which cannot be attributed to Actinic Cheilitis
- Individuals, who are dependent from the sponsor
- Individuals, who are institutionalized or imprisoned by court order or other official institution
- Any indication that the subject is unlikely to adhere to the protocol (e.g. lack of compliance)
- Simultaneous treatment with topical preparations (including cosmetics) or keratolytic substances (e.g. sulphur, salicylic acid, benzoyl peroxide, resorcine and chemical abrasives), soaps with peeling and strongly dehydrating effects, perfumes, citrus extracts, topical antibiotics, corticosteroids, retinoid or azalaic acid within 2 weeks before start of trial intervention (day 0)
- Intensive natural or artificial UV light therapy (e.g. UVB, UVA, PUVA) within 4 weeks before start of trial intervention (day 0)
- Intake of antibiotics or glucocorticosteroids within 4 weeks before start of trial intervention (day 0)
- Intake of retinoids within 6 months before start of trial intervention (day 0)
- Topical treatment of Actinic Cheilitis within 8 weeks before start of trial intervention (day 0)
- Severe systemic concomitant diseases (as per investigator’s assessment) or any immunosuppressive treatment
- Known severe renal- or hepatic diseases which need close surveillance and therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.