2023-509931-15-00招募中4 期
Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
研究概览
简要总结
Assess the efficacy at 8 months of a combined approach associating cryotherapy and tirbanibulin, repeated at 4 months (only if persistent keratosis with regard to cryotherapy) on actinic keratosis of the scalp.
研究设计
- 分配方式
- Randomized
- 主要目的
- Hémiscalp Expérimental
- 盲法
- Double (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old with Scalp containing ≥ 8 typical, clinically visible or palpable grade I or II actinic keratosis with at least 4 actinic keratosis per hemi-scalp.
- •Patient who, according to the investigator's opinion, are in good general condition (WHO ≤2).
- •The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade.
- •Patient able to understand and agree to the study visit schedule and other protocol requirements.
- •Patient able to understand and voluntarily sign an informed consent form.
- •Patient with social insurance.
- •Patient willing to comply with all study procedures and study duration.
排除标准
- •Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification.
- •A defined treatment area, which would be : - On an area other than the scalp and/or forehead. - Within 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma.
- •Previous treatment with Tirbanibulin.
- •Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatment for actinic keratosis in the treatment area, or within 2 cm around this area, in the 6 weeks prior to the screening visit.
- •Use of the following therapies within 2 weeks prior to the screening visit: - Therapeutic or cosmetic procedures (e.g. use of liquid nitrogen, surgical excision, dermabrasion, medium or deep chemical peel, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area. - Therapeutic products containing acid (e.g. salicylic acid, fruit acids, etc.), 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 pathology entailing a risk of poor compliance.
- •Administrative reasons: inability to receive informed information, inability to take part in the entire study, lack of social security cover, refusal to sign consent, etc.
结局指标
主要结局
Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.
次要结局
- Complete response rate for actinic keratosis at 12 months.
- Partial response rate (= 75% reduction of lesions) at 8 months.
- Partial response rate (= 75% reduction of lesions) at 12 months.
- Number of cryotherapy sessions carried out over the follow-up period.
- Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10.
- The photographs taken during the visits will be analysed using computer-aided image processing.
研究者
Pr. Laurent MORTIER
Scientific
Centre Hospitalier Universitaire De Lille
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical CancerCervical CancerNCT04300647Hoffmann-La Roche172
已完成
4 期
Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.Pulmonary Disease, Chronic ObstructiveNCT00388882Boehringer Ingelheim327
已完成
1 期
Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast CancerBreast CarcinomaHER-2 Positive Breast CancerMetastatic Breast CancerNCT02066532Dawn L. Hershman32
尚未招募
3 期
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast CancerBreast CancerNCT05841381Fudan University876
已完成
不适用
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT01229462Allergan238