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NCT01529788 · ClinicalTrials.gov registry record · Phase 4
Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study
A Phase 4 study of Intrinsic Aging of Skin and Solar Elastosis, sponsored by The Maas Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT01529788 is a Phase 4 study of Intrinsic Aging of Skin and Solar Elastosis that has completed, run by The Maas Clinic. The registered enrollment target is 90 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01529788, a Phase 4 study of Intrinsic Aging of Skin and Solar Elastosis, has completed, sponsored by The Maas Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin. The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles \[0\], very fine wrinkles \[1\], fine wrinkles \[2\], moderate wrinkles \[3\] or severe wrinkles \[4\]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.
Conditions Studied
Interventions
- DRUG Right lateral orbital injection of Botox Cosmetic or Dysport
- DRUG Left lateral orbital injection of Botox Cosmetic or Dysport
Study Locations (1)
California
- The Maas Clinic - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01529788
The ClinicalTrials.gov registry entry for NCT01529788 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Maas Clinic, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Intrinsic Aging of Skin appearing as the primary indexed condition, and to 2 interventions - of which Right lateral orbital injection of Botox Cosmetic or Dysport is the first listed.
NCT01529788 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01529788 about?
NCT01529788 is a clinical study titled "Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study". The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate to severe lateral orbital rhytids at m...
What is the current status of trial NCT01529788?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2009-09. Estimated completion is 2014-09.
What conditions does trial NCT01529788 study?
This clinical trial studies the following conditions: Intrinsic Aging of Skin, Solar Elastosis.
What interventions are being tested in trial NCT01529788?
The interventions under investigation include: Right lateral orbital injection of Botox Cosmetic or Dysport (DRUG), Left lateral orbital injection of Botox Cosmetic or Dysport (DRUG).
Who is sponsoring clinical trial NCT01529788?
This trial is sponsored by The Maas Clinic, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01529788 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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