Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo

Vitiligo Clinical Trial

— NSV  

Official title:

A Phase II Randomised Pilot Study to Compare the Efficacy and Safety of Subcutaneous, Bioresorbable Afamelanotide Implants and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382589
• Other study ID #: CUV101
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: March 21, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Clinuvel Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).

Description:

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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Male and female subjects with a confirmed diagnosis of 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

Exclusion criteria:

• 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

• Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic 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 ß-HCG pregnancy test) or 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Afamelanotide
NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation

Device:
• NB-UVB
NB-UVB light therapy 3-times per week, for total of 72 treatments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo	Time to onset of repigmentation of full body, face, trunk and extremities Pigmentation by VASI and VETF Maintenance of pigmentation Dermatology Life Quality Index (DLQI); Safety of the treatment will be assessed by: For selected study sites, immunomodulatory assessment Full body anterior and posterior photography Vitiligo lesion photography Examination of the skin and oral mucosa and digital photography Ophthalmologic examination	6 months	No
Secondary	Maintenance of pigmentation achieved		6 months	No