SCENESSE + NB-UVB Light for Vitiligo

Not currently recruiting at 31 trial locations

Overseen By Director of Global Clinical Affairs

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Clinuvel, Inc.

Disqualifiers: Fitzpatrick I-II, Melanoma, Hepatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment, afamelanotide (also known as Scenesse), combined with NB-UVB light for individuals with vitiligo, a condition where skin loses color in patches. Researchers aim to determine if this combination is more effective than NB-UVB light alone. The goal is to improve skin color on both the body and face. Suitable candidates for this trial have generalized vitiligo, have not recently undergone NB-UVB phototherapy, and have skin types III-VI, which tan easily and rarely burn. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it excludes those who have had certain treatments for vitiligo within 30 days before the study. It's best to discuss your current medications with the trial team to see if they might interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining the safety of combining afamelanotide with NB-UVB light therapy for vitiligo treatment. Afamelanotide, also known as SCENESSE®, has approval in Europe for other conditions, suggesting potential safety. Patients in Europe using SCENESSE® have demonstrated a safety profile, but its safety for vitiligo remains under study.

It is important to note that afamelanotide has not been proven safe for children and is used in such cases without official approval. However, its use in adults may provide some confidence in its safety for them. NB-UVB light is a common treatment for skin issues and is generally safe, though it can sometimes cause mild skin irritation or redness.

In summary, while the full safety of using afamelanotide with NB-UVB light for vitiligo is still under investigation, the existing approval of SCENESSE® in Europe and its use in adults may offer some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for vitiligo?

Unlike the standard treatments for vitiligo, which often involve topical corticosteroids or calcineurin inhibitors, SCENESSE (afamelanotide) combined with NB-UVB light is grabbing attention because it uses a unique approach. Afamelanotide is a synthetic version of a natural hormone that promotes skin pigmentation, potentially speeding up the repigmentation process when paired with light therapy. This combination not only aims to enhance the effectiveness of light treatment but also could offer faster and more sustained results. Researchers are excited because this could mean a more efficient and longer-lasting solution for people with vitiligo.

What evidence suggests that this trial's treatments could be effective for vitiligo?

This trial will compare the effectiveness of two treatments for vitiligo. One group of participants will receive a combination of afamelanotide and NB-UVB light, while another group will receive NB-UVB light alone. Studies have shown that combining afamelanotide with NB-UVB light helps vitiligo patients regain their skin color faster and more completely. In some cases, skin color began to return in just two days. Patients experienced improvements in both spotty and even skin color. Research indicates that afamelanotide increases the activity of melanocytes, the cells that produce skin color, which helps maintain the color after treatment ends. This combination treatment has proven more effective than using NB-UVB light alone. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for males and females aged 12 or older with generalized vitiligo, having certain skin types (IV-VI), and a minimum affected body area. Participants should not have had recent NB-UVB therapy, severe liver issues, be pregnant/lactating, or have a history of serious skin conditions like melanoma.

Inclusion Criteria

You have vitiligo that is not changing or is actively spreading.

I have been diagnosed with widespread vitiligo covering more than 0.3% of my body.

I am 12 years old or older.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I am a sexually active man not using birth control with a partner who can get pregnant.

I have severe liver disease or impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive afamelanotide and NB-UVB light or NB-UVB light alone

20 weeks

Regular visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Afamelanotide
• NB-UVB Light

Trial Overview The study compares the effectiveness and safety of SCENESSE (afamelanotide) combined with NB-UVB light versus just NB-UVB light in treating vitiligo on the body and face to see if adding SCENESSE improves results.

How Is the Trial Designed?

Group I: NB-UVB Light Experimental Treatment 1 Intervention

Group II: Afamelanotide and NB-UVB Light Experimental Treatment 1 Intervention

Afamelanotide is already approved in European Union, United States for the following indications:

Approved in European Union as Scenesse for:

• Erythropoietic protoporphyria

Approved in United States as Scenesse for:

• Erythropoietic protoporphyria

Who Is Running the Clinical Trial?

Clinuvel, Inc.

Lead Sponsor

Trials

2

Recruited

210+

Published Research Related to This Trial

Afamelanotide (Scenesse®) effectively protects patients with erythropoietic protoporphyria (EPP) from sunlight-induced skin reactions by stimulating melanin production through the melanocortin 1 receptor (MC1R).

Despite the presence of low titers of antibodies against α-MSH in some individuals, afamelanotide did not induce neutralizing antibodies that would block its biological effects, indicating its safety and efficacy even after prolonged use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bioassay for the detection of neutralizing antibodies against the α-melanocyte stimulating hormone analog afamelanotide in patients with erythropoietic protoporphyria. Spichty, R., Balimann, M., Barman, J., et al.[2017]

In a study of 150 vitiligo patients treated with narrow-band ultraviolet B (NBUVB) therapy, 73% achieved 25-75% repigmentation, demonstrating the therapy's efficacy across various age groups.

NBUVB therapy was found to be safe, with minimal adverse effects; only three patients experienced depigmentation of repigmented areas, indicating a good stability of cosmetic results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of narrow-band UVB phototherapy in 150 patients with vitiligo. Kishan Kumar, YH., Rao, GR., Gopal, KV., et al.[2022]

Home-based narrowband ultraviolet B (NB-UVB) phototherapy for new-onset vitiligo was found to be as effective as hospital-based treatment, with both groups showing significant improvements in skin repigmentation and quality of life after 8 weeks.

However, patients receiving home treatment experienced more adverse effects, such as painful erythema and blistering, highlighting the need for better patient education to manage UVB exposure safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home vs hospital narrowband UVB treatment by a hand-held unit for new-onset vitiligo: A pilot randomized controlled study. Liu, B., Sun, Y., Song, J., et al.[2020]

Afamelanotide, a synthetic hormone approved in the EU, significantly improves light tolerance in adults with erythropoietic protoporphyria (EPP), allowing patients to spend more time in sunlight without experiencing pain.

The treatment was generally well tolerated in a phase III trial, with no serious adverse events reported, although common side effects included headaches and reactions at the implant site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afamelanotide: A Review in Erythropoietic Protoporphyria. Kim, ES., Garnock-Jones, KP.[2017]

Afamelanotide, a synthetic analog of alpha-melanocyte stimulating hormone, is being tested in phase II and III trials for various skin conditions, showing promise for diseases like vitiligo and erythropoietic protoporphyria.

Currently available in Italy and Switzerland for erythropoietic protoporphyria, afamelanotide is facing challenges from counterfeit products marketed online, highlighting the need for regulation and awareness regarding its legitimate use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review and update on melanocyte stimulating hormone therapy: afamelanotide. Fabrikant, J., Touloei, K., Brown, SM.[2017]

In a study of 80 patients with vitiligo, combining narrowband UVB (NBUVB) light therapy with excimer laser treatment led to a positive response in 54 patients, suggesting that this combination may enhance treatment effectiveness.

The combination therapy was generally safe, with no significant side effects reported, which could improve patient compliance with the treatment regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with excimer laser and narrowband UVB light in vitiligo patients. Shin, S., Hann, SK., Oh, SH.[2016]

The combination of afamelanotide implant and narrowband UV-B (NB-UV-B) phototherapy significantly improved repigmentation in patients with generalized vitiligo compared to NB-UV-B monotherapy, with a notable response observed as early as 41 days for the face.

Patients with darker skin types (Fitzpatrick skin phototypes IV to VI) experienced greater benefits from the combination therapy, achieving a repigmentation rate of 48.64% at day 168, compared to 33.26% in the monotherapy group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. Lim, HW., Grimes, PE., Agbai, O., et al.[2017]

Afamelanotide, an analogue of α-melanocyte stimulating hormone, has shown effectiveness in treating various skin conditions that have not responded well to other therapies, including erythropoietic protoporphyria and vitiligo.

The treatment has a relatively low risk of side effects, making it a promising option for patients and opening possibilities for its use in other medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afamelanotide in the Treatment of Dermatologic Disease McNeil, MM., Nahhas, AF., Braunberger, TL., et al.[2019]

Afamelanotide, an α-MSH analogue, effectively increases skin pigmentation by binding to the melanocortin-1 receptor (MC1R), enhancing melanin synthesis and providing protective effects against phototoxicity, particularly in patients with erythropoietic protoporphyria (EPP).

Long-term studies (up to 25 years) show that afamelanotide has no significant late effects or immunogenic potential, with adverse effects being generally benign, supporting its safety for use in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Minder, EI., Barman-Aksoezen, J., Schneider-Yin, X.[2020]

In a study involving 11 vitiligo patients, localized 311-nm narrow-band ultraviolet B (NB-UVB) treatment resulted in over 50% repigmentation in 20% of the lesions, demonstrating its effectiveness for vitiligo.

In contrast, the 308-nm monochromatic excimer light (MEL) treatment did not achieve any lesions with more than 50% repigmentation after 24 sessions, indicating that NB-UVB is a superior option for localized vitiligo treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapatient comparison of 308-nm monochromatic excimer light and localized narrow-band UVB phototherapy in the treatment of vitiligo: a randomized controlled trial. Verhaeghe, E., Lodewick, E., van Geel, N., et al.[2015]

Citations

1. dermatologytimes.com dermatologytimes.com/view/clinuvel-completes-enrollment-in-phase-iii-afamelanotide-vitiligo-trial

Clinuvel Completes Enrollment in Phase III Afamelanotide ... These reports suggest not only early onset of repigmentation but also continued melanocyte activity following the conclusion of therapy, raising ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05210582

NCT05210582 | A Study to Assess the Changes in ... The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.

3. clinuvel.com clinuvel.com/2025/09/scenesse-efficacy-in-vitiligo-new-cases-presented-to-eadv-20250919/

SCENESSE® efficacy in vitiligo: new cases presented to ... SCENESSE® efficacy in vitiligo: new cases presented to EADV. Three new case studies demonstrate extent and stability of repigmentation in CUV105.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23407924/

The efficacy of afamelanotide and narrowband UV-B ... Afamelanotide induced faster and deeper repigmentation in each case. All patients experienced follicular and confluent areas of repigmentation within 2 days to ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/1377949

The Efficacy of Afamelanotide and Narrowband UV-B ... All patients experienced moderate to rapid repigmentation after the afamelanotide implants compared with our patients receiving NB–UV-B ...

6. clinuvel.com clinuvel.com/wp-content/uploads/2025/09/20250923-ema-approves-year-round-scenesse-treatment.pdf

EMA approves year-round SCENESSE® treatment The data package included a review of the safety and effectiveness profile of SCENESSE® in the. European patients who have received four or more ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602608/

Afamelanotide - LiverTox - NCBI Bookshelf - NIH The safety and efficacy of afamelanotide have not been proven in children, in whom it has been used off-label. Afamelanotide is available as ...

8. ema.europa.eu ema.europa.eu/fr/media/38510

EU Risk Management Plan for SCENESSE® (afamelanotide) Analyses comparing long term safety data and outcome endpoints in EPP patients receiving treatment with SCENESSE® (Treated Group) and those not receiving ...