Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

NCT01004107 | Completed Results

• 1 other identifier: P0508332
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Aging Hands

Outcome Measures

Primary Outcomes (3)

• Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand

  To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

  3 months from baseline

• ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand

  To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

  3 months from baseline

• ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject

  To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.

  3 months from baseline

Secondary Outcomes (14)

• Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand

  3, 6, 9, and 12 months from baseline

• ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand

  3, 6, 9, and 12 months from baseline

• ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject

  3, 6, 9, and 12 months from baseline

• Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only

  3 months from baseline

• Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only

  3 months from baseline

Study Arms (2)

Radiesse Injectable Dermal Filler

EXPERIMENTAL

Device: Radiesse Injectable Dermal Filler

Device: Radiesse Injectable Dermal Filler

Delayed Treatment

ACTIVE COMPARATOR

Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months

Device: Radiesse Injectable Dermal Filler

Interventions

Radiesse Injectable Dermal Filler DEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Delayed Treatment; Radiesse Injectable Dermal Filler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (4)

Merz Investigative Site #001

Munich, Germany

Location

Merz Investigative Site #002

Munich, Germany

Location

Merz Investigative Site #003

Munich, Germany

Location

Merz Investigative Site #004

Munich, Germany

Location

Related Publications (1)

• 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

  BACKGROUND

Results Point of Contact

• Title: Ashlee Duncan
• Organization: Merz North America

ashlee.duncan@merz.com

984-222-6040

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2017-09

Locations

DE (4)