2023-507470-40-00招募中3 期
A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.
研究概览
简要总结
To evaluate the efficacy of SCENESSE® and NB-UVB compared to NB-UVB alone in repigmentation of vitiligo
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase III Vitiligo Study
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female participants with a confirmed diagnosis of generalized vitiligo in the face and body
- •Stable or active vitiligo diagnosed for at least three months
- •Fitzpatrick skin types III-VI
- •Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
- •Providing written Informed Consent prior to the performance of any study-specific procedure
排除标准
- •Fitzpatrick skin types I-II
- •Any other treatment for vitiligo within 30 days prior to the Screening Visit
- •History of melanoma or lentigo maligna
- •History of dysplastic nevus syndrome
- •Any malignant skin lesions
- •Any skin disease that may interfere with the study evaluation
- •Presence of severe hepatic disease or hepatic impairment
- •Female who is pregnant or lactating
- •Female of child-bearing potential not using effective contraceptive methods
- •Sexually active man with a partner of child-bearing potential who is not using effective contraceptive methods
- •Use of any prior and concomitant therapy which may interfere with the objective of the study
- •Extensive leukotrichia
- •Treatment with NB-UVB phototherapy in the last three months prior to phototherapy
- •Allergy to afamelanotide or the polymer contained in the implant
结局指标
主要结局
Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.
Percentage of participants achieving re pigmentation in those treated with SCENESSE® and NB-UVB compared to NB-UVB alone.
次要结局
- Time to onset of repigmentation
- Time to onset of repigmentation of face
研究者
Head of Clinical Operations
Scientific
Clinuvel Inc.
研究点 (3)
Loading locations...
相似试验
尚未招募
3 期
SWE-NEO: Swedish NeoAdjuvant Trial Comparing anti-PD-1 Monotherapy to Combined anti-CTLA-4/anti-PD-1 blockade in Resectable Stage III Melanoma2024-519593-39-00Karolinska University Hospital128
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus ErythematosusSLECLESystemic Lupus ErythematosusNCT07260877Ventus Therapeutics U.S., Inc.24
招募中
2 期
PLUG-IN. Phase 2 of pembrolizumab combined with enfortumab vedotin for advanced melanoma patients.Advanced Melanoma2024-514163-26-00Grupo Espanol Multidisciplinar De Melanoma60
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90