Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Study Details
Study Description
Brief Summary
Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Restylane and Restylane with Lidocaine This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive. |
Device: Restylane and Restylane-L
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
|
Outcome Measures
Primary Outcome Measures
- Treatment Difference in Pain as Measured by a Visual Analogue Scale [After Injection on Day of Treatment]
No pain is noted at 0 mm and worst pain is noted at 100 mm.
Secondary Outcome Measures
- Wrinkle Improvement at Day 14 [14 days after treatment when compared to baseline]
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects seeking augmentation therapy for correction of bilateral NLFs
-
Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
-
Subjects willing to give written informed consent to participate in the study
-
Women of childbearing potential willing to use an acceptable form of birth control during the study period
Exclusion Criteria:
-
Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
-
Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
-
Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
-
Permanent implant placed in the NLF area
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dermatology Research Institute LLC | Coral Gables | Florida | United States | 33146 |
| 2 | Maryland Laser Skin and Vein Institute | Hunt Valley | Maryland | United States | 21030 |
| 3 | The Center for Dermatology, Cosmetic and Laser Surgery | Mount Kisco | New York | United States | 10549 |
Sponsors and Collaborators
- Medicis Global Service Corporation
- Q-Med Scandinavia, Inc.
Investigators
- Principal Investigator: David Bank, MD, The Center for Dermatology, Cosmetic and Laser Surgery
- Principal Investigator: Fredric Brandt, MD, Dermatology Research Institute LLC
- Principal Investigator: Robert Weiss, MD, Maryland Laser Skin and Vein Institute
- Study Director: Ron Staugaard, Medicis Pharmaceutical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-1100-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Restylane |
|---|---|
| Arm/Group Description | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. |
| Period Title: Overall Study | |
| STARTED | 60 |
| COMPLETED | 60 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Restylane |
|---|---|
| Arm/Group Description | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. |
| Overall Participants | 60 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
60
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.1
(6.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
58
96.7%
|
| Male |
2
3.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
60
100%
|
Outcome Measures
| Title | Treatment Difference in Pain as Measured by a Visual Analogue Scale |
|---|---|
| Description | No pain is noted at 0 mm and worst pain is noted at 100 mm. |
| Time Frame | After Injection on Day of Treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS). |
| Arm/Group Title | Restylane | Restylane-L |
|---|---|---|
| Arm/Group Description | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. |
| Measure Participants | 60 | 60 |
| Measure Scores on a Scale | 100 | 100 |
| Mean (Standard Deviation) [Scores on a VAS Scale] |
44.9
(31.5)
|
14.7
(17.7)
|
| Title | Wrinkle Improvement at Day 14 |
|---|---|
| Description | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. |
| Time Frame | 14 days after treatment when compared to baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Restylane-L Side of Face | Restylane Side of Face |
|---|---|---|
| Arm/Group Description | Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). | The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). |
| Measure Participants | 60 | 60 |
| Number [participants] |
60
100%
|
59
NaN
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Restylane-L Side of Face | Restylane Side of Face | ||
| Arm/Group Description | Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). | The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). | ||
All Cause Mortality |
||||
| Restylane-L Side of Face | Restylane Side of Face | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Restylane-L Side of Face | Restylane Side of Face | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Restylane-L Side of Face | Restylane Side of Face | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 46/60 (76.7%) | 46/60 (76.7%) | ||
| General disorders | ||||
| Edema | 24/60 (40%) | 24 | 22/60 (36.7%) | 22 |
| Erythema | 28/60 (46.7%) | 28 | 27/60 (45%) | 27 |
| Tenderness | 23/60 (38.3%) | 23 | 26/60 (43.3%) | 26 |
| Pain | 17/60 (28.3%) | 17 | 18/60 (30%) | 18 |
| Pruitis | 6/60 (10%) | 6 | 4/60 (6.7%) | 4 |
| Papule | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 |
| Vasospasm | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Vascular disorders | ||||
| Ecchymosis | 23/60 (38.3%) | 23 | 19/60 (31.7%) | 19 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Ron Staugaard |
|---|---|
| Organization | Medicis |
| Phone | 480-291-5652 |
| rstaugaard@medicis.com |
- MA-1100-001