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NCT01586819 · ClinicalTrials.gov registry record · Phase 3
Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
A Phase 3 study, sponsored by Loyola University.
- Completed
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT01586819: Completed Phase 3 study, sponsored by Loyola University.
NCT01586819 is a Phase 3 study that has completed, run by Loyola University. The registered enrollment target is 26 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01586819, a Phase 3 study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
Primary Outcome
The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
Interventions
- DRUG Botulinum Toxin
- PROCEDURE Chemical Peel Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01586819 record still lists
NCT01586819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Botulinum Toxin is the first listed.
NCT01586819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01586819 about?
NCT01586819 is a clinical study titled "Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A". This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a p...
What is the current status of trial NCT01586819?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2011-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01586819?
The interventions under investigation include: Botulinum Toxin (DRUG), Chemical Peel Only (PROCEDURE).
Who is sponsoring clinical trial NCT01586819?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01586819's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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