Clinical trial NCT02650921: Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
Official title: A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Deficit in the Hand
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 92
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.


Eligibility criteria: Key Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images.
* Males or females, 22 years of age or older
* Willing and able to perform hand functionality tests .

Key Exclusion Criteria:

* History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
* History of allergy or hypersensitivity to lidocaine or other amide type anesthetics.
* Previous hand surgery including sclerotherapy, or history of hand trauma.
* Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.

Primary outcomes:
measure: Responder Rate Using Validated Hand Grading Scale
timeFrame: 12 Weeks
Secondary outcomes:
measure: Responder Rate Using Validated Hand Grading Scale
timeFrame: 16 weeks
measure: Responder Rate Using Validated Hand Grading Scale
timeFrame: 20 weeks
measure: Responder Rate Using Validated Hand Grading Scale
timeFrame: 24 weeks
measure: Improvement in Hand as Evaluated by IPR
timeFrame: 12 weeks
measure: Improvement in Hand as Evaluated by IPR
timeFrame: 16 weeks
measure: Improvement in Hand as Evaluated by IPR
timeFrame: 20 weeks
measure: Improvement in Hand as Evaluated by IPR
timeFrame: 24 weeks
measure: GAIS by Treating Investigator
timeFrame: 12 weeks
measure: GAIS by Treating Investigator
timeFrame: 16 weeks
measure: GAIS by Treating Investigator
timeFrame: 20 weeks
measure: GAIS by Treating Investigator
timeFrame: 24 weeks
measure: Evaluate GAIS by Subjects
timeFrame: 12 weeks
measure: Evaluate GAIS by Subjects
timeFrame: 16 weeks
measure: Evaluate GAIS by Subjects
timeFrame: 20 weeks
measure: Evaluate GAIS by Subject
timeFrame: 24 weeks
measure: Question 1 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 2 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 3 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 4 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 5 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 6 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 7 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 8 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 9 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 10 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 11 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 12 From Subject Satisfaction Questionnaire
timeFrame: Week 12
measure: Question 13 From Subject Satisfaction Questionnaire
timeFrame: Week 12
Other outcomes:
Locations:
city: Vista
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Boca Raton
country: United States
state: Florida
city: Saint Louis
country: United States
state: Missouri
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
Study officials:
References:
citation: Moradi A, Allen S, Bank D, Marmur E, Fagien S, Glaser DA, Maguire C, Cohen JL. A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand. Plast Reconstr Surg. 2019 Oct;144(4):586e-596e. doi: 10.1097/PRS.0000000000006070.