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Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial

NCT02349009 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-08-17

No results posted yet for this study

Summary

1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP) for the modified Rodnan skin score (MRSS). Study subjects will be randomized to apply the active study medication daily for 4 weeks to either the right or left forearm and placebo to the contralateral forearm.

Conditions

  • Systemic Scleroderma

Interventions

DRUG

C-82 Topical Gel, 1%

active

DRUG

C-82 Topical Gel, Placebo

placebo

Sponsors & Collaborators

  • Prism Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert Lafyatis, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349009 on ClinicalTrials.gov