Study Summary
This trial is testing whether a certain type of drug can help improve vitiligo, a condition where patches of skin lose their color. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the experimental treatment until the trial is over.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks)
6 months (24 weeks)
Percentage change from baseline in facial segment of Body Surface Area affected (F-BSA)
6 months (week 24)
Proportion of participants achieving 50% or greater improvement from baseline in total (T)-VASI
Proportion of participants achieving 90% or greater improvement from baseline in F-VASI
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) rating of "a lot less noticeable" or "no longer noticeable"
Proportion of participants achieving at 50% or greater improvement from baseline in facial Vitiligo Area Scoring Index (F)-VASI
Month 3
Assessment of melanocyte population expansion via immunohistochemistry (IHC) studies
Quantification of pigment via Fontana-Masson staining
Month 6
Assessment of percent change from baseline in serum key inflammatory chemokines
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
6 Treatment Groups
Active NBUVB plus vehicle ointment
1 of 6
Active NBUVB plus Crisaborole 2% topical ointment
1 of 6
Sham phototherapy plus crisaborole 2% topical ointment
1 of 6
Sham phototherapy plus PF-07038124 0.01% topical ointment
1 of 6
Active NBUVB plus PF-07038124 0.01% topical ointment
1 of 6
Sham phototherapy plus vehicle ointment
1 of 6
Active Control
Experimental Treatment
Non-Treatment Group
64 Total Participants · 6 Treatment Groups
Primary Treatment: NBUVB phototherapy · Has Placebo Group · Phase 2
Active NBUVB plus Crisaborole 2% topical ointmentExperimental Group · 2 Interventions: Crisaborole 2 % Topical Ointment, NBUVB phototherapy · Intervention Types: Drug, Device
Sham phototherapy plus crisaborole 2% topical ointmentExperimental Group · 2 Interventions: Crisaborole 2 % Topical Ointment, Sham phototherapy · Intervention Types: Drug, Device
Sham phototherapy plus PF-07038124 0.01% topical ointmentExperimental Group · 3 Interventions: PF-07038124 0.01% topical ointment, Sham phototherapy, Vehicle · Intervention Types: Drug, Device, Drug
Active NBUVB plus PF-07038124 0.01% topical ointmentExperimental Group · 3 Interventions: PF-07038124 0.01% topical ointment, Vehicle, NBUVB phototherapy · Intervention Types: Drug, Drug, Device
Active NBUVB plus vehicle ointmentActiveComparator Group · 2 Interventions: Vehicle, NBUVB phototherapy · Intervention Types: Drug, Device
Sham phototherapy plus vehicle ointmentPlaceboComparator Group · 2 Interventions: Sham phototherapy, Vehicle · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle
2013
Completed Phase 3
~4830
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (pre-treatment) and at 3 months (12 weeks) and 6 months (24 weeks)
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,590 Previous Clinical Trials
1,927,174 Total Patients Enrolled
1 Trials studying Vitiligo
47 Patients Enrolled for Vitiligo
PfizerIndustry Sponsor
4,304 Previous Clinical Trials
7,094,700 Total Patients Enrolled
5 Trials studying Vitiligo
142,921 Patients Enrolled for Vitiligo
Stanca Birlea, MDPrincipal InvestigatorUniversity of Colorado, Denver
Eligibility Criteria
Age 18 - 75 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have vitiligo vulgaris or acrofacial vitiligo for at least 3 months.
You have a BSA of at least 0.5% of the facial area.
You have agreed that the treatment area will involve 3%-25% BSA.
You must agree to stop all other treatments for vitiligo from screening through 1 week after discontinuation of study drug treatment.
You have body surface area involvement of 3%-90% of the body.
You must agree to avoid exposure to the sun as much as possible and not to use tanning booths, sun lamps, or other ultraviolet light sources other than requested by the study team during the study.
Who else is applying?
What state do they live in?
| Colorado | 50.0% |
| Tennessee | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Colorado Anschutz - Clinical and Translational Research Centers | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
Why did patients apply to this trial?
- "i have friend who participated in various trials and is happy with the outcome."
What questions have other patients asked about this trial?
- "what is compensation ?"
How many prior treatments have patients received?
| 0 | 100.0% |
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Conditions
Cancer Related
Treatments