Facial Wrinkles Clinical Trial
Official title:
Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA
The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.
Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01447342 -
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
|
Phase 2/Phase 3 | |
| Completed |
NCT00978887 -
Retorna Facial Cream in the Treatment of Facial Wrinkles
|
Phase 3 | |
| Completed |
NCT00414544 -
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
|
Phase 2 | |
| Completed |
NCT00888914 -
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
|
Phase 2 | |
| Completed |
NCT00877279 -
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
|
Phase 3 | |
| Completed |
NCT01124565 -
Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
|
Phase 2 | |
| Completed |
NCT00922623 -
Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI
|
N/A | |
| Not yet recruiting |
NCT03836638 -
The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment
|
N/A | |
| Not yet recruiting |
NCT06322875 -
A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection
|
N/A | |
| Completed |
NCT01566396 -
Evaluation of Safety and Efficacy of the 3F Applicator (A3F) for Treatment of Facial Wrinkles
|
N/A | |
| Completed |
NCT01151436 -
Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers
|
N/A | |
| Completed |
NCT06321770 -
Oral Supplementation With Active Collagen Peptides and Skin Health Improvement
|
N/A | |
| Completed |
NCT01379365 -
Cryo-Touch III Refinement Study Investigational Plan
|
Phase 2/Phase 3 | |
| Completed |
NCT00288470 -
A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
|
N/A | |
| Completed |
NCT01167140 -
Cryo-Touch II for the Treatment of Wrinkles
|
Phase 2/Phase 3 | |
| Completed |
NCT00968825 -
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
|
Phase 2 | |
| Completed |
NCT03286283 -
The Use of J-Plasma® for Dermal Resurfacing
|
N/A | |
| Completed |
NCT01064518 -
Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
|
Phase 2 | |
| Completed |
NCT00417469 -
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)
|
Phase 3 | |
| Completed |
NCT00293163 -
A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.
|
Phase 4 |