CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Topical resiquimod 0.06% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01676831
NCT01676831Phase 2Completed
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A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma

Abramson Cancer Center at Penn Medicine·interventional·Posted Aug 31, 2012·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating Topical resiquimod 0.06% and topical resiquimod 0.03% for Cutaneous T Cell Lymphoma. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients. This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products Development, FDA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous T Cell Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJan 1, 2015
Study CompletionSep 28, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.8 years ago

Interventions

Topical resiquimod 0.06%drug

topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest.

topical resiquimod 0.03%drug

topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period.