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

NCT01430195 | Completed Phase 1

• 1 other identifier: CUV102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Vitiligo

Keywords

vitiligo; depigmentation; phototherapy; non-segmental vitiligo

Outcome Measures

Primary Outcomes (1)

• Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Afamelanotide + NB-UVB: Experimental

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).

Drug: Afamelanotide

NB-UVB alone: Active Comparator

ACTIVE COMPARATOR

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

Procedure: Narrow-Band UVB Light Treatment

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 Other Name: CUV1647

Also known as: CUV1647

Afamelanotide + NB-UVB: Experimental

Narrow-Band UVB Light Treatment PROCEDURE

To be administered 3 times/week for 6 months. 72 treatments in total.

Also known as: NB-UVB light treatment

NB-UVB alone: Active Comparator

Eligibility Criteria

• Age: 18 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 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
• 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

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (2)

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

The Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• Lim HW, Grimes PE, Agbai O, Hamzavi I, Henderson M, Haddican M, Linkner RV, Lebwohl M. Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 2015 Jan;151(1):42-50. doi: 10.1001/jamadermatol.2014.1875.

  PMID: 25230094 DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

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

Study Officials

• Henry Lim, MD

  Henry Ford Hospital, 3031 W. Grand Blvd., Suite 800, Detroit, MI 48202, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: September 8, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (2)