SCENESSE + NB-UVB Light for Vitiligo

Recruiting at30 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Clinuvel, Inc.

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for vitiligo that combines a drug called afamelanotide with a special type of light therapy. The goal is to see if this combination works better than the light therapy alone in helping people with vitiligo regain their skin color.

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.

What data supports the effectiveness of the drug Afamelanotide combined with NB-UVB light for treating vitiligo?

Research shows that Afamelanotide, which helps increase skin pigmentation, has been effective in treating various skin conditions, including vitiligo, when used with NB-UVB light therapy. This combination has shown promising results in improving skin color in vitiligo patients. ^{1 2 3 4 5}

Is the treatment with Afamelanotide and NB-UVB Light generally safe for humans?

Afamelanotide, used in combination with NB-UVB Light, has been generally well tolerated in clinical trials for various skin conditions, with no serious drug-related adverse events reported. Common side effects include headaches and reactions at the implant site, but no long-term harmful effects have been observed even after prolonged use. ^{1 2 4 5 6}

How is the SCENESSE + NB-UVB Light treatment for vitiligo different from other treatments?

The SCENESSE + NB-UVB Light treatment combines afamelanotide, which helps induce skin tanning, with narrowband UVB light therapy, a common treatment for vitiligo. This combination may enhance the repigmentation process compared to using narrowband UVB light alone. ^{1 7 8 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Afamelanotide (Melanocortin Receptor Agonist)
• NB-UVB Light (Procedure)

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.

Participant Groups

Group I: NB-UVB Light Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Clinuvel, Inc.

Lead Sponsor

Trials

2

Recruited

210+

Findings from Research

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, 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]

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 (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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A review and update on melanocyte stimulating hormone therapy: afamelanotide. [2017]

3. Canada pubmed.ncbi.nlm.nih.gov

Afamelanotide in the Treatment of Dermatologic Disease [2019]

4. England 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. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Afamelanotide: A Review in Erythropoietic Protoporphyria. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of narrow-band UVB phototherapy in 150 patients with vitiligo. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Combination treatment with excimer laser and narrowband UVB light in vitiligo patients. [2016]

9. Switzerland 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. [2015]

10. England 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. [2020]