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Ruxolitinib Cream for Non-segmental Vitiligo

Chu Nice Hopital Archet 2, Nice, France
Non-segmental VitiligoRuxolitinib Cream - Drug
Eligibility
18+
All Sexes

Study Summary

This trial tests a cream that might help repigment skin affected by vitiligo, used twice a day for up to 48 weeks.

Eligible Conditions
  • Nonsegmental Vitiligo with Genital Involvement

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

0 Primary · 6 Secondary · Reporting Duration: Week 24 and 48

52 weeks
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Week 24
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
Week 24 and 48
Change from baseline in affected Body Surface Area BSA in the genital region
Proportion of participants achieving T-VASI50/75/90
Proportion of participants in each category of the color-matching question
Week 48
Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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2
Ruxolitinib cream
2
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Side Effects for

Vehicle Cream BID
4%Headache
3%Upper respiratory tract infection
2%Nasopharyngitis
1%Nasal sinus cancer
1%Dermatitis atopic
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03745638) in the Vehicle Cream BID ARM group. Side effects include: Headache with 4%, Upper respiratory tract infection with 3%, Nasopharyngitis with 2%, Nasal sinus cancer with 1%, Dermatitis atopic with 1%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Ruxolitinib Cream
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Ruxolitinib Cream · No Placebo Group · Phase 2

Ruxolitinib Cream
Drug
Experimental Group · 1 Intervention: Ruxolitinib Cream · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Cream
2018
Completed Phase 3
~640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 24 and 48

Who is running the clinical trial?

Incyte CorporationLead Sponsor
331 Previous Clinical Trials
48,127 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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References

Frequently Asked Questions

Has the FDA authorized Ruxolitinib Cream for therapeutic use?

"According to the assessments made by our team at Power, Ruxolitinib Cream was given a score of 2 on a scale from 1-3. This is because there are preliminary indications that it is safe but no data confirming its efficacy in this Phase 2 trial." - Anonymous Online Contributor

Unverified Answer

Are there still openings for research participants in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical study, which was initially listed on April 11th 2023, is actively recruiting volunteers. A total of 30 patients are needed to be recruited across 13 seperate sites." - Anonymous Online Contributor

Unverified Answer

How many individuals have volunteered to partake in this experiment?

"This clinical trial necessitates 30 participants meeting the set of established inclusion criteria. Patients can join from either Vitiligo & Pigmentation Institute of Southern California in Los Angeles, Michigan or Hamzavi Dermatology in Fort Gratiot, Ohio." - Anonymous Online Contributor

Unverified Answer

In how many geographic locations is this trial taking place?

"13 sites across the United States of America are currently running this clinical trial. These locations include Los Angeles, Fort Gratiot and Mayfield with additional centres situated in other cities. To reduce travel demands for potential participants it is wise to select a nearby site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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