2022-502807-31-00已完成2 期
Exploratory pilot study to determine the tolerability and effectiveness of Tirbanibulin in the treatment of Actinic Cheilitis
Technische Universitat Dresden1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete recovery rate (healing) of Actinic Cheilitis, 8 weeks after the application of Tirbanibulin for 5 days (visit 4, day 56). Complete recovery is defined as an affected area of 0 cm.
研究概览
简要总结
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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Complete recovery rate (healing) of Actinic Cheilitis, 8 weeks after the application of Tirbanibulin for 5 days (visit 4, day 56). Complete recovery is defined as an affected area of 0 cm.
Complete recovery rate (healing) of Actinic Cheilitis, 8 weeks after the application of Tirbanibulin for 5 days (visit 4, day 56). Complete recovery is defined as an affected area of 0 cm.
次要结局
- Reduction of the affected area by means of the size of the affected lip area in cm² and the reduction of the affected area in % at day 56 compared to baseline (area in cm² at baseline, area in cm² at day 56, reduction of the area in %)
- Study subject self-assessment (individual and total scores according to the visit schedule as well as the difference of the scores compared to baseline)
- Local skin reaction score (individual and total scores as per visit schedule as well as the difference of the scores compared to baseline
- Oral Health DLQI-Score (individual and total scores as per visit as well as the difference of the scores compared to baseline)
- Frequency of AEs and SAEs during the duration of the trial (visit 4)
- Discrepancies in diagnosing Actinic Cheilitis by means of optical coherence tomography, confocal laser scanning microscopy, line-field confocal optical coherence tomography, diagnostic confidence, imaging quality at baseline compared to the final visit.
研究者
Dr. med. Roland Aschoff
Scientific
Technische Universitat Dresden
研究点 (1)
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