Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2009
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
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 28, 2020
August 1, 2020
2 months
April 17, 2009
August 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Baseline (Day 0) and Week 6
Study Arms (2)
1
EXPERIMENTALRT001 (Botulinum Toxin Type A Topical Gel)
2
PLACEBO COMPARATORVehicle Control
Interventions
Two sequential doses of RT001 at Baseline (Day 0) and Week 2
Eligibility Criteria
You may qualify if:
- Female/male ages 30 to 55
- Bilateral lateral canthal lines rated as moderate or advanced.
- Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
- Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
You may not qualify if:
- Muscle weakness or paralysis in the area receiving treatment.
- Active skin disease or irritation at treatment areas.
- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
- Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
- Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6).
- Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, 77056, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Bruce, MD
The Center for Skin Research
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
April 17, 2009
First Posted
April 20, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
August 28, 2020
Record last verified: 2020-08