Proof of Concept Study to Compare Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Nonsegmental Vitiligo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores
研究概览
简要总结
The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo. Afamelanotide is expected to speed up the repigmentation induced by NB-UVB light, leading to reducing frequency and doses of NB-UVB.
详细描述
Vitiligo is the most common depigmentation disorder. Interventions in the treatment of vitiligo include phototherapy with narrow-band (NB) ultraviolet B (UVB) irradiation (NB-UVB). Further therapeutic approaches are desired and currently being evaluated. The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). The earliest described function of alpha-MSH is its ability to stimulate melanin synthesis in the skin and therefore stimulate pigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with a confirmed diagnosis nonsegmental vitiligo with 15% to 50% of total body surface involvement
- •Stable or slowly progressive vitiligo over a 3-month period
- •Aged 18 or more
- •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
- •Vitiligo involving the hands and feet only
- •Extensive leukotrichia, in the opinion of the Investigator
- •Vitiligo of more than 5 years duration
- •Previous treatment with NB-UVB within 6 months prior to the Screening Visit
- •Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator
- •Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anesthetic to be used during the administration of the implant
- •Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit
- •History of photosensitivity disorders
- •Claustrophobia
- •History of photosensitive lupus
- •Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator
- •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
- •Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator
- •History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation
- •Female who is pregnant (confirmed by positive β-HCG pregnancy test), are lactating
- •Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) during the trial and for a period of three months thereafter
- •Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of three months hereafter
- •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit
- •Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit
- •Subjects assessed as not suitable for the study in the opinion of the Investigator
研究组 & 干预措施
Afamelanotide + NB-UVB: Experimental
Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 4 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total).
干预措施: Afamelanotide (Drug)
NB-UVB alone: Active Comparator
Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).
干预措施: Narrow-Band UVB Light Treatment (Procedure)
结局指标
主要结局
Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores
时间窗: 6 months
次要结局
- Time to onset of repigmentation of full body, face, trunk and extremities(6 months)
- Quality of life using the Dermatology Life Quality Index (DLQI)(6 months)
- Vitiligo biopsies assessments (optional, selected sites only)(6 months)
- Short term safety of both treatments: Routine laboratory assessments - Full body anterior and posterior photography - Vitiligo lesion photography - Examination of the skin and oral mucosa and digital photography - Ophthalmologic examination(6 months)
- Maintenance of pigmentation using the VASI and VETF scores(12 months)