VitiligoPhase 2NSVNCT01382589
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo
A Phase 2 study testing Afamelanotide and NB-UVB in people with Vitiligo, run by Clinuvel Pharmaceuticals Limited.
Trial summary
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Afamelanotide and NB-UVB
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
- 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
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- 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
About this study
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
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Afamelanotide, NB-UVB
- 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
NB-UVBDevice
NB-UVB light therapy 3-times per week, for total of 72 treatments
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Afamelanotide + NB-UVB | Experimental | 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) Receives: Drug: Afamelanotide |
| Arm B: NB-UVB alone | Active comparator | Subjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total) Receives: Device: NB-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
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
Measured: 6 months
Secondary outcomes (1)
Maintenance of pigmentation achieved
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Leone, MD, Principal investigator, San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382589
- Sponsor's protocol ID
- CUV101
- Acronym
- NSV
- Status last verified
- Mar 2013
- First submitted
- 7 Jun 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01382589
- Acronym / sponsor ID
- NSV / CUV101
- Conditions
- Vitiligo
- Keywords
- vitiligo, depigmentation, phototherapy, non-segmental vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether afamelanotide and narrow band UVB are effective in the treatment of non-segmental vitiligo (NSV).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Afamelanotide + NB-UVB | Experimental | Drug: AfamelanotideSubject 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) |
| Arm B: NB-UVB alone | Active comparator | Device: NB-UVBSubjects in this arm B will receive NB-UVB light only (administered thrice weekly, 72 treatments in total) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfamelanotideAlso: CUV1647NB-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 | Drug | Arm A: Afamelanotide + NB-UVB |
| NB-UVBNB-UVB light therapy 3-times per week, for total of 72 treatments | Device | Arm B: NB-UVB alone |
Primary outcome
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo
Time frame: 6 months
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
1 secondary outcome
Maintenance of pigmentation achieved
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Leone, MD principal investigator
San Gallicano Dermatological Institute, Photodermatology Unit, Roma, ITALY
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afamelanotide and NB-UVB in people with Vitiligo, run by Clinuvel Pharmaceuticals Limited.
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 22 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.