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

Phase 1

Completed

• Conditions: Vitiligo
• Interventions: Drug: Afamelanotide; Procedure: Narrow-Band UVB Light Treatment

• Registration Number: NCT01430195
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-08
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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.

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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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afamelanotide + NB-UVB: Experimental	Afamelanotide	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).
NB-UVB alone: Active Comparator	Narrow-Band UVB Light Treatment	Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).

Primary Outcome Measures

Name	Time	Method
Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Henry Ford Medical Center; 🇺🇸 Detroit, Michigan, United States

The Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States