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

NCT01382589 | Completed Phase 2

• 1 other identifier: CUV101
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Vitiligo

Keywords

vitiligo; depigmentation; phototherapy; non-segmental vitiligo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Maintenance of pigmentation achieved

  6 months

Study Arms (2)

Arm A: Afamelanotide + NB-UVB

EXPERIMENTAL

Subject in this arm will receive both afamelanotide implants (one implant administered every 28 days, 6 implants in total) and NB-UVB light (administered thrice weekly, 72 treatments in total)

Drug: Afamelanotide

Arm B: NB-UVB alone

ACTIVE COMPARATOR

Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)

Device: NB-UVB

Interventions

Afamelanotide DRUG

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

Also known as: CUV1647

Arm A: Afamelanotide + NB-UVB

NB-UVB DEVICE

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

Arm B: NB-UVB alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

MeSH Terms

Conditions

Vitiligo

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giovanni Leone, MD

  San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 22, 2013

Record last verified: 2013-03