Evaluation of Radiesse® Dermal Filler for Hand Treatment

Merz Pharmaceuticals

Status: Completed

Conditions: Aging Hands

Treatments: Device: Radiesse® Injectable Dermal Filler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01832090

P110607

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, 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: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Radiesse® Injectable Dermal Filler

Experimental group

Description:

Device: Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)

Treatment:

Device: Radiesse® Injectable Dermal Filler

Delayed Treatment

Active Comparator group

Description:

Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) at 3 months

Treatment:

Device: Radiesse® Injectable Dermal Filler