Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

Merz Pharmaceuticals

Status: Completed

Conditions: Aging Hands

Treatments: Device: Radiesse Injectable Dermal Filler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01004107

P0508332

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Radiesse Injectable Dermal Filler

Experimental group

Description:

Device: Radiesse Injectable Dermal Filler

Treatment:

Device: Radiesse Injectable Dermal Filler

Delayed Treatment

Active Comparator group

Description:

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

Treatment:

Device: Radiesse Injectable Dermal Filler