Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
Active, enrolledPhase 2Results postedLast updated 10 February 2026
What this trial tests
Phase 2 trial testing topical ruxolitinib 1.5% cream in Non-sclerotic Cutaneous Chronic Graft-versus-host Disease in 24 participants. Participants enrolled and being followed up; not accepting new ones.
12 and older, any sex, with Non-sclerotic Cutaneous Chronic Graft-versus-host Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Reduction in Body Surface Area (BSA) From Day 1 and Day 28Primary· 28 days (+/-3 days)
The difference in BSA of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion
BSA on Day 1 for Topical Ruxolitinib BID to Left Side of Face/Body
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
14.4
± 0.003
BSA on Day 28 for Topical Ruxolitinib BID to Left Side of Face/Body
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
6.2
± 0.003
BSA on Day 1 for Topical Ruxolitinib BID to Right Side of Face/Body
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
14.5
± 0.003
BSA on Day 28 for Topical Ruxolitinib BID to Right Side of Face/Body
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
10.4
± 0.003
Improvement in Physician's Global Assessment of Clinical Condition (PGA) at From Day 1 and Day 28Secondary· 28 days (+/-3 days)
The difference in the Physician's Global Assessment/PGA of non-sclerotic and superficially sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion (day 28 visit). Grade of Rash as follows: Grade 0, Clinical Complete Response, Completely clear; NED (100% improvement); Grade 1-3, Partial Response, from very significant clearance to moderate improvement (\>90% to \>/= 50% improvement); Grade 4 and 5, Stable Disease, No change to some improvement (,50% to \>/=25%); Grade 6, Progressive Disease, Disease is worse than at baseline eval
Topical Ruxolitinib BID to Left Side of Face/Body PGA on Day 1
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
5
± 0.0004
Topical Ruxolitinib BID to Left Side of Face/Body PGA on Day 28
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
1.9
± 0.0004
Topical Ruxolitinib BID to Right Side of Face/Body PGA on Day 1
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
5
± 0.0004
Topical Ruxolitinib BID to Right Side of Face/Body PGA on Day 28
Group
Value
95% CI
Experimental: Participants With Graft-versus-host Disease (GVHD)
3.7
± 0.0004
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 days (+/-3 days).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Experimental: Participants With Graft-versus-host Disease (GVHD)
Serious: 2/24 (8%)
Deaths: 8/24
Experimental Left: Participants With Graft-versus-host Disease (GVHD)
Serious: 0/12 (0%)
Deaths: 0/12
Experimental Right: Participants With Graft-versus-host Disease (GVHD)
Serious: 0/12 (0%)
Deaths: 0/12
Serious adverse events (2 terms)
Reaction
System
Experimental: Participants…
Experimental Left: Partici…
Experimental Right: Partic…
Sinusitis
Infections and infestations
—
—
—
Neoplasm Benign, Malignant and Unspecified (incl cysts and polyps) - Other, specify - CNS Leukemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03954236.