Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
1 other identifier
interventional
40
1 country
3
Brief Summary
This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.
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 May 2010
Shorter than P25 for phase_2
3 active sites
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
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 12, 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 17, 2014
December 1, 2013
2 months
May 12, 2010
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of treatment-emergent adverse events based on safety assessments.
4 weeks and 8 weeks
Study Arms (1)
RT001
EXPERIMENTALRT001 (Botulinum Toxin Type A) Topical Gel
Interventions
RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas
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 woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
- Previous treatment with botulinum toxin (any serotype)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Schlessinger, M.D.
Skin Specialists, PC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2010
First Posted
May 17, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 17, 2014
Record last verified: 2013-12