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VitiligoPhase 1CUV102NCT01430195

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

A Phase 1 study testing Afamelanotide and Narrow-Band UVB Light Treatment in people with Vitiligo, run by Clinuvel Pharmaceuticals Limited at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
Afamelanotide and Narrow-Band UVB Light Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
2 sitesUnited States
Study dates
Jun 2011to Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • The Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Vitiligo
Being tested
Afamelanotide, Narrow-Band UVB Light Treatment
Keywords
vitiligo, depigmentation, phototherapy, non-segmental vitiligo
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfamelanotideDrug

    Also called CUV1647

    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

  • Narrow-Band UVB Light TreatmentProcedure or surgery

    Also called NB-UVB light treatment

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

Study groups in NCT01430195
Study groupRoleWhat they receive
Afamelanotide + NB-UVB: ExperimentalExperimentalSubject 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).
Receives: Drug: Afamelanotide
NB-UVB alone: Active ComparatorActive comparatorSubjects in this arm will receive NB-UVB light only (administered thrice weekly, 72 treatments in total).
Receives: Procedure: Narrow-Band UVB Light Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (5)

  1. Time to onset of repigmentation of full body, face, trunk and extremities

    Measured: 6 months

  2. Quality of life using the Dermatology Life Quality Index (DLQI)

    Measured: 6 months

  3. Vitiligo biopsies assessments (optional, selected sites only)

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. Maintenance of pigmentation using the VASI and VETF scores

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01430195
Sponsor's protocol ID
CUV102
Other IDs
CUV102
Acronym
CUV102
Status last verified
Mar 2013
First submitted
18 Aug 2011
Last updated
22 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25230094

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Afamelanotide and Narrow-Band UVB Light Treatment in people with Vitiligo, run by Clinuvel Pharmaceuticals Limited at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pigmentation of full body, face, trunk and extremities using the VASI and VETF scores (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.

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