Exploratory study to determine the tolerability and effectiveness of Tirbanibulin in the treatment of Actinic Cheilitis - Cheilitis trial

Phase 1

Recruiting

• Conditions: MedDRA version: 21.1Level: PTClassification code: 10056951Term: Actinic cheilitis Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; Actinic Cheilitis

• Registration Number: CTIS2022-502807-31-00
• Lead Sponsor: Technische Universitat Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified