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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 140 to 308

Awards & highlights

Study Summary

This trial will investigate if a drug and light therapy are better than light therapy alone for treating vitiligo on the body and face.

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.Check my eligibility

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.See study design

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.

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I am 12 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of patients achieving VASI50 on the body

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: NB-UVB LightExperimental Treatment1 Intervention

Group II: Afamelanotide and NB-UVB LightExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clinuvel, Inc.Lead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

1 Trials studying Vitiligo

6 Patients Enrolled for Vitiligo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration certified Afamelanotide and NB-UVB Light?

"The safety of Afamelanotide and NB-UVB Light is classified as a 3 due to prior clinical data backing efficacy, in addition to multiple rounds of research indicating its security."

Answered by AI

How many participants have been registered for this clinical investigation?

"Affirmative. Clinicaltrials.gov has documented that this clinical research, which was first published on October 11th 2023, is actively in search of participants. A total of 200 patients are expected to be recruited from a single medical facility."

Answered by AI

Does this experimental research currently require volunteers?

"Affirmative. According to information presented on clinicaltrials.gov, this medical trial - which appeared online on October 11th 2023 - is currently enrolling patients. A total of 200 participants are needed from a single location."

Answered by AI