Clinical trial NCT01004107: Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Official title: Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Hands
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 101
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.

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 a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
* Signs a written informed consent
* Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
* Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

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 used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
* Has had any dermal fillers or surgery in the dorsum of the hand
* Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating

Primary outcomes:
measure: Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
timeFrame: 3 months from baseline
measure: ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
timeFrame: 3 months from baseline
Secondary outcomes:
measure: Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
timeFrame: 3, 6, 9, and 12 months from baseline
measure: ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
timeFrame: 3, 6, 9, and 12 months from baseline
measure: ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
timeFrame: 3 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only
timeFrame: 3 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Physician Satisfaction Evaluation
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Patient Satisfaction Evaluation
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
timeFrame: 3, 6, 9, and 12 months from baseline
measure: Mean Hand Function Rating During Prior Week
timeFrame: Baseline and 3, 6, 9, and 12 months post-treatment
measure: Difficulty Performing Activities During Prior Week
timeFrame: Baseline and 3, 6, 9, and 12 months post-treatment
measure: Difficulty Performing Activities During Prior Week, Both Hands
timeFrame: Baseline and 3, 6, 9, and 12 months post-treatment
measure: Normal Work During Prior Week Evaluation
timeFrame: Baseline and 3, 6, 9, and 12 months post-treatment
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Merz Investigative Site #001
city: Munich
country: Germany
facility: Merz Investigative Site #002
city: Munich
country: Germany
facility: Merz Investigative Site #003
city: Munich
country: Germany
facility: Merz Investigative Site #004
Study officials:
References:
citation: Busso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797