Phase 2 N=46 Randomized Treatment

Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Oral Chronic Graft-versus-host Disease

Bottom Line

View on ClinicalTrials.gov: NCT00686855 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Feb 2014

Primary outcome: Primary: The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD. — 15; 3; 11; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tacrolimus (Drug); Dexamethasone (Drug)
Age: Pediatric, Adult, Older Adult · 4+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Dec 2012

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	—

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)

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

View full record on ClinicalTrials.gov →

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.