Phase 2
Completed N=46
Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Oral Chronic Graft-versus-host Disease
Source: ClinicalTrials.gov NCT00686855 ↗
Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Feb 2014
Primary outcomePrimary: The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD. — 15; 3; 11; 2 participants
Summary
The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD. |
15; 3; 11; 2; 11; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with oral chronic graft-versus-host disease
- Patients 4 years of age or older
- Stable cGVHD medication regimen for the four weeks prior to study enrollment
Exclusion Criteria
- Patients already on topical steroid or tacrolimus therapies
Data sourced from ClinicalTrials.gov (NCT00686855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.