A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJanuary 30, 2014
December 1, 2013
3 months
May 6, 2010
December 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subject improvement based in investigator assessment
The number of subjects who show improvement based on the investigator global assessment
Week 4
Secondary Outcomes (1)
Subject Improvement Based on investigator and patient assessments
Week 4
Study Arms (4)
RT001 Botulinum toxin Type A (Dose A)
EXPERIMENTALRT001 (Botulinum toxin Type A)
RT001 Botulinum toxin type A (Dose B)
EXPERIMENTALRT001 (Botulinum Toxin Type A)
Dose C
OTHERVehicle Control
Dose D
PLACEBO COMPARATORPlacebo
Interventions
RT001 Botulinum Toxin Type A (Dose A)
RT001 Botulinum Toxin Type A (Dose B)
Eligibility Criteria
You may qualify if:
- Written informed consent including authorization to release health information
- Female or male, 18 to 65 years of age and in good general health
- Willing and able to follow study instructions and likely to complete all study requirements
- Moderate to severe lateral canthal lines (crow's feet wrinkles)
You may not qualify if:
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active disease or irritation at the treatment areas including the eye and the skin
- Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 17, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 30, 2014
Record last verified: 2013-12