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A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea

NCT01614743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-10-08

Study results available
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Summary

This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.

Conditions

  • Rosacea

Interventions

DRUG

IncobotulinumtoxinA

Experimental injection given at baseline and Week 16

DRUG

Bacteriostatic saline

Placebo at baseline, incobotulinumtoxinA at 16 weeks

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • DeNova Research

    lead OTHER

Principal Investigators

  • Steven H Dayan, MD · DeNova Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01614743 on ClinicalTrials.gov