Trial record 7 of 55 for:    "vitiligo"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01382589
First received: June 7, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Vitiligo
Drug: Afamelanotide
Device: NB-UVB
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Clinuvel Pharmaceuticals Limited:

Primary Outcome Measures:
  • To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Maintenance of pigmentation achieved [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Afamelanotide + NB-UVB
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
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
Active Comparator: Arm B: NB-UVB alone
Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total)
Device: NB-UVB
NB-UVB light therapy 3-times per week, for total of 72 treatments

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 β-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
  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: NCT01382589

Sponsors and Collaborators
Clinuvel Pharmaceuticals Limited
Investigators
Principal Investigator: Giovanni Leone, MD San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY
  More Information

No publications provided

Responsible Party: Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01382589     History of Changes
Other Study ID Numbers: CUV101
Study First Received: June 7, 2011
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

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 11, 2014