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 - CUV105

Clinuvel Inc.0 个研究点目标入组 200 人开始时间: 2023年12月6日最近更新: 2024年8月21日

适应症

试验速览

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•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 IV-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

•Fitzpatrick skin types I-III, Any other treatment for vitiligo within four weeks 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 adequate contraceptive measures, Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures, 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

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