- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430195
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) (CUV102)
March 21, 2013 updated by: Clinuvel Pharmaceuticals Limited
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
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Medical Center
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New York
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New York, New York, United States, 10029
- The Mount Sinai School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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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 Names:
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ACTIVE_COMPARATOR: NB-UVB alone: Active Comparator
Subjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).
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To be administered 3 times/week for 6 months.
72 treatments in total.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to onset of repigmentation of full body, face, trunk and extremities
Time Frame: 6 months
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6 months
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Quality of life using the Dermatology Life Quality Index (DLQI)
Time Frame: 6 months
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6 months
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Vitiligo biopsies assessments (optional, selected sites only)
Time Frame: 6 months
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6 months
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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
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6 months
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Maintenance of pigmentation using the VASI and VETF scores
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henry Lim, MD, Henry Ford Hospital, 3031 W. Grand Blvd., Suite 800, Detroit, MI 48202, USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
May 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
August 18, 2011
First Submitted That Met QC Criteria
September 6, 2011
First Posted (ESTIMATE)
September 8, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 22, 2013
Last Update Submitted That Met QC Criteria
March 21, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUV102 (OTHER: Clinuvel)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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