Clinical trial NCT01832090: Evaluation of Radiesse® Dermal Filler for Hand Treatment
Official title: Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Hands
Keywords: aging
hands
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merz Aesthetics Inc.
First posted: 2013-04-15
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

Detailed description: This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Eligibility criteria: Inclusion Criteria:

* Has right and left hands with rating of 2 or 3 on the Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator
* Is at least 18 years of age

Exclusion Criteria:

* Has history of hypertropic scarring
* Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
* Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
* Has received in past 6 months or plans to receive during the study dermal resurfacing procedure (chemical peel, dermabrasion, ablative laser resurfacing) or non-invasive skin tightening (Thermage®) in the dorsum of the hands
* Has received in past 2 weeks or plans to receive during the study prescription wrinkle therapies, topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) in the dorsum of the hands
* Has had any dermal fillers or surgery in the dorsum of the hand

Primary outcomes:
measure: Mean Change on Merz Hand Grading Scale (MHGS), by Hand
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject
timeFrame: 3 months from baseline
Secondary outcomes:
measure: Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years
timeFrame: 3 months from baseline
measure: Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only
timeFrame: 3 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only
timeFrame: 3 months from baseline
measure: Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment
timeFrame: 3, 6, 9, and 12 months from baseline
measure: ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment
timeFrame: 3, 6, 9, and 12 months from baseline
measure: ≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment
timeFrame: 3, 6, 9, and 12 months from baseline
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Merz Investigative Site #004
state: California
city: Vista
country: United States
facility: Merz Investigative Site #007
state: California
city: Garden City
country: United States
facility: Merz Investigative Site #002
state: New York
city: New York
country: United States
facility: Merz Investigative Site #006
state: New York
city: Nashville
country: United States
facility: Merz Investigative Site #003
state: Tennessee
city: Plano
country: United States
facility: Merz Investigative Site #001
state: Texas
Study officials:
References: