Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) (CUV102)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01430195
First received: August 18, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Vitiligo
Drug: Afamelanotide
Procedure: Narrow-Band UVB Light Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Clinuvel Pharmaceuticals Limited:

Primary Outcome Measures:
  • Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of repigmentation of full body, face, trunk and extremities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life using the Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Vitiligo biopsies assessments (optional, selected sites only) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Maintenance of pigmentation using the VASI and VETF scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
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 Other Name: CUV1647
Other Name: CUV1647
Active Comparator: NB-UVB alone: 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
To be administered 3 times/week for 6 months. 72 treatments in total.
Other Name: NB-UVB light treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430195

Locations
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, New York
The Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Clinuvel Pharmaceuticals Limited
Investigators
Principal Investigator: Henry Lim, MD Henry Ford Hospital, 3031 W. Grand Blvd., Suite 800, Detroit, MI 48202, USA
  More Information

Additional Information:
No publications provided

Responsible Party: Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01430195     History of Changes
Other Study ID Numbers: CUV102, CUV102
Study First Received: August 18, 2011
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Clinuvel Pharmaceuticals Limited:
vitiligo
depigmentation
phototherapy
non-segmental vitiligo

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Alpha-MSH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014