What is the mechanism of action of this treatment?

Common treatments for Vitiligo, such as Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) therapy, work by stimulating melanogenesis and melanocyte activity to promote repigmentation. Afamelanotide specifically enhances melanin production, while NB-UVB therapy encourages melanocyte migration to depigmented areas. Topical corticosteroids and calcineurin inhibitors help by reducing inflammation and immune response, potentially halting further depigmentation. These mechanisms are crucial for Vitiligo patients as they offer pathways to restore skin color and improve their quality of life.

What side effects are associated with this type of intervention?

Common treatments for vitiligo, such as narrow-band ultraviolet B (NB-UVB) light therapy, can cause side effects including skin redness, itching, and a mild sunburn-like reaction. Topical corticosteroids, another common treatment, may lead to skin thinning, stretch marks, and increased risk of skin infections with prolonged use. Afamelanotide, which is being studied for its ability to stimulate melanogenesis and promote repigmentation, may cause side effects such as nausea, headache, and injection site reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, the FDA has not approved many treatments specifically for vitiligo. The primary treatments include topical corticosteroids, calcineurin inhibitors, and narrow-band ultraviolet B (NB-UVB) phototherapy. Afamelanotide, which is being studied for its ability to stimulate melanogenesis and promote repigmentation, represents a novel approach. This treatment is still under investigation and has not yet received FDA approval for vitiligo.

What other types of research exist?

One promising alternative to Afamelanotide for Vitiligo patients is the combination of Narrow-Band Ultraviolet B (NB-UVB) light therapy with other agents. Specifically, the CUV105 study is assessing the efficacy and safety of combining NB-UVB light with Afamelanotide. Additionally, other potential treatments include JAK inhibitors like tofacitinib, which have shown promise in treating autoimmune conditions like alopecia areata and may have potential for Vitiligo. These treatments are being actively researched and could offer new options for patients in 2024.

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Melanocortin Receptor Agonist

SCENESSE + NB-UVB Light for Vitiligo

Phase 3

Recruiting

Research Sponsored by Clinuvel, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3

Aged 12 or more

Must not have

Female who is pregnant or lactating

Female of child-bearing potential not using adequate contraceptive measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 140 to 308

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions at the implant site for afamelanotide, such as redness or pain. Both treatments could potentially cause skin irritation due to exposure to UV light.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently pregnant or breastfeeding.

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I am a woman who can have children and am not using birth control.

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I have had melanoma or lentigo maligna in the past.

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I have skin cancer lesions.

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I have severe liver disease or impairment.

Select...

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

Select...

I have a history of abnormal mole syndrome.

Select...

I am allergic to afamelanotide or its implant material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 140 to 308

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 140 to 308

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 140 to 308 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients achieving VASI50 on the body

Secondary study objectives

Percentage change in pigmentation on body surface area measured by the VASI scoring system

Percentage change in pigmentation on facial surface area measured by the VASI scoring system

Percentage of patients achieving VASI25/75/90 on the body

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: NB-UVB LightExperimental Treatment1 Intervention

Group II: Afamelanotide and NB-UVB LightExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vitiligo, such as Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) therapy, work by stimulating melanogenesis and melanocyte activity to promote repigmentation. Afamelanotide specifically enhances melanin production, while NB-UVB therapy encourages melanocyte migration to depigmented areas. Topical corticosteroids and calcineurin inhibitors help by reducing inflammation and immune response, potentially halting further depigmentation. These mechanisms are crucial for Vitiligo patients as they offer pathways to restore skin color and improve their quality of life.