VitiligoPhase 2NCT02809976
Topical Ruxolitinib for the Treatment of Vitiligo
A Phase 2 study testing Ruxolitinib 1.5% Phosphate Cream in people with Vitiligo, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ruxolitinib 1.5% Phosphate Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of vitiligo.
- At Visit 1 (Baseline/Day 1), have had vitiligo covering at least 1% of total body surface area (BSA) on the scalp, trunk or limbs (excluding nails).
- Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least four weeks after the last dose of assigned treatment. Male subjects must also use contraception, such as barrier method with spermicide.
- If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
- Must be willing to washout of other vitiligo treatments. All treatments for vitiligo are prohibited during the course of the study.
Who cannot join
- Other skin conditions at Baseline that would interfere with evaluation of vitiligo.
- Pregnant/breastfeeding females, or females of childbearing potential not using highly effective contraception. Women of childbearing potential must test negative for pregnancy and use contraception for at least four weeks after last dose of drug.
- Current or recent history of clinically significant medical/psychiatric condition or laboratory abnormality that may increase risk associated with the study participation or drug administration.
- Have a history of any lymphoproliferative disorder, lymphoma, leukemia, history of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to Baseline.
- Vaccinated with live/attenuated live vaccine within 6 weeks prior to Baseline.
Show all 13Show fewer
- Previously participated in study of oral/topical ruxolitinib or tofacitinib (tofacitinib, CP-690,550, formerly tasocitinib) unless confirmed to have been randomized to and treated with placebo or placebo topical formulation (vehicle) only.
- Received a prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to Baseline.
- Have participated in other studies within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1 (Baseline/Day 1). Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
- Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Sponsor employees directly involved in the conduct of the trial.
- In the opinion of the investigator or Sponsor, the subject is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle guidelines.
- Screening laboratory abnormalities
- CYP Inhibitor Exclusion: Subjects taking potent CYP3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Phase 2 Proof-of-concept Pilot Trial of Topical Ruxolitinib in Repigmenting Adult Patients With Vitiligo
The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions.
Read the detailed description
The hypothesis is that JAK inhibitors can also successfully treat vitiligo. Lesional skin of both alopecia areata and vitiligo primarily contain T cells in a TH1 response as opposed to a mixed cell infiltrate such as in psoriasis or lichen planus. Both alopecia areata and vitiligo are TH1 mediated diseases dependent on the production of IFN-gamma to drive the response. CD8+ T cells are both necessary and sufficient for melanocyte destruction in vitiligo (van den Boorn JG et al 2009) and CD8+NKG2D+ T cells are also necessary and sufficient for hair loss in alopecia areata (Gilhar A et al 2013).
- Conditions
- Vitiligo
- Being tested
- Ruxolitinib 1.5% Phosphate Cream
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% Phosphate CreamDrug
Also called INCB018424 phosphate cream
twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 1.5% phosphate cream | Experimental | Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches. Receives: Drug: Ruxolitinib 1.5% Phosphate Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20
The VASI for each body region (hands, upper extremities, trunk, lower extremities, feet) is determined by the product of the area involved in hand prints and the extent of depigmentation within each hand print unit measured patch (0-100). Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. Degree of depigmentation is measured as: 1.00 (100%) = complete depigmentation, no pigment present, 0.90(90%)=specks of pigment present, 0.75(75%)=depigmented area exceeds the pigmented area, 0.50(50%)=pigmented and depigmented areas are equal, 0.25(25%)=pigmented area exceeds depigmented area, 0.10(10%)=only specks of depigmentation present, and 0.0(0%)=no depigmentation present.
Measured: Baseline to Week 20
Secondary outcomes (6)
Percent Change in Body Surface Area (BSA) of Repigmentation
Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100.
Measured: Baseline and Week 20
Number of Subjects Who Achieve a Physician Global Vitiligo Assessment (PGVA) of Clear or Almost Clear
Measured: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Body Surface Area
Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other.
Measured: Baseline and Week 20
Mean Dermatology Life Quality Index (DLQI) Scores
DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The percent change was calculated from the mean DLQI at baseline and week 20
Measured: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Staging
Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other.
Measured: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Progression
Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other.
Measured: Baseline and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rosmarin, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809976
- Sponsor's protocol ID
- I-18424-15-06
- Status last verified
- Aug 2020
- First submitted
- 20 Jun 2016
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase 2 Proof-of-concept Pilot Trial of Topical Ruxolitinib in Repigmenting Adult Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT02809976
- Acronym / sponsor ID
- I-18424-15-06
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions.
Detailed description
The hypothesis is that JAK inhibitors can also successfully treat vitiligo. Lesional skin of both alopecia areata and vitiligo primarily contain T cells in a TH1 response as opposed to a mixed cell infiltrate such as in psoriasis or lichen planus. Both alopecia areata and vitiligo are TH1 mediated diseases dependent on the production of IFN-gamma to drive the response. CD8+ T cells are both necessary and sufficient for melanocyte destruction in vitiligo (van den Boorn JG et al 2009) and CD8+NKG2D+ T cells are also necessary and sufficient for hair loss in alopecia areata (Gilhar A et al 2013).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 1.5% phosphate cream | Experimental | Drug: Ruxolitinib 1.5% Phosphate CreamRuxolitinib 1.5% phosphate cream twice daily to vitiligo patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of vitiligo.
- At Visit 1 (Baseline/Day 1), have had vitiligo covering at least 1% of total body surface area (BSA) on the scalp, trunk or limbs (excluding nails).
- Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least four weeks after the last dose of assigned treatment. Male subjects must also use contraception, such as barrier method with spermicide.
- If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen.
- Must be willing to washout of other vitiligo treatments. All treatments for vitiligo are prohibited during the course of the study.
Key exclusion criteria (13 listed)
- Other skin conditions at Baseline that would interfere with evaluation of vitiligo.
- Pregnant/breastfeeding females, or females of childbearing potential not using highly effective contraception. Women of childbearing potential must test negative for pregnancy and use contraception for at least four weeks after last dose of drug.
- Current or recent history of clinically significant medical/psychiatric condition or laboratory abnormality that may increase risk associated with the study participation or drug administration.
- Have a history of any lymphoproliferative disorder, lymphoma, leukemia, history of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- Have a history of infection requiring parenteral or oral or topical antimicrobial therapy within 2 weeks prior to Baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 1.5% Phosphate CreamAlso: INCB018424 phosphate creamtwice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20 | Drug | Ruxolitinib 1.5% phosphate cream |
Primary outcome
Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20
Time frame: Baseline to Week 20
The VASI for each body region (hands, upper extremities, trunk, lower extremities, feet) is determined by the product of the area involved in hand prints and the extent of depigmentation within each hand print unit measured patch (0-100). Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. Degree of depigmentation is measured as: 1.00 (100%) = complete depigmentation, no pigment present, 0.90(90%)=specks of pigment present, 0.75(75%)=depigmented area exceeds the pigmented area, 0.50(50%)=pigmented and depigmented areas are equal, 0.25(25%)=pigmented area exceeds depigmented area, 0.10(10%)=only specks of depigmentation present, and 0.0(0%)=no depigmentation present.
6 secondary outcomes
Percent Change in Body Surface Area (BSA) of Repigmentation
Time frame: Baseline and Week 20
Number of Subjects Who Achieve a Physician Global Vitiligo Assessment (PGVA) of Clear or Almost Clear
Time frame: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Body Surface Area
Time frame: Baseline and Week 20
Mean Dermatology Life Quality Index (DLQI) Scores
Time frame: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Staging
Time frame: Baseline and Week 20
Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Progression
Time frame: Baseline and Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rosmarin, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib 1.5% Phosphate Cream in people with Vitiligo, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20 (time frame: Baseline to Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.