Overview

This trial is active, not recruiting.

Condition volume loss in the dorsum of the hand
Treatment radiesse injectable implant and 2% lidocaine hcl
Sponsor Merz Pharmaceuticals, LLC
Start date June 2016
End date September 2018
Trial size 250 participants
Trial identifier NCT02904096, P151009, M900311002

Summary

The primary objective of this study is to evaluate the safety of Radiesse implantation for very severe volume loss in the dorsum of the hand at 6 months after treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
"Grade 4 Hands" group will be subjects with hand grading of grade 4 (very severe loss of fatty tissue, marked visibility of veins and tendons in the dorsal hand). "Grade 4 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 4 Hands" group can have up to three retreatments over an 18 month period.
radiesse injectable implant and 2% lidocaine hcl
Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.
(Experimental)
"Grade 2 or 3 Hands" group will be subjects with hand grading of grade 2 or grade 3 (moderate to severe loss of fatty tissue, mild to moderate visibility of veins and tendons in the dorsal hand). "Grade 2 or 3 Hands" group subjects will receive Radiesse injectable implant and 2% lidocaine HCL up to 3 cc (2 syringes) per hand per treatment. Subjects in "Grade 2 or 3 Hands" group can have up to three retreatments over an 18 month period.
radiesse injectable implant and 2% lidocaine hcl
Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.

Primary Outcomes

Measure
Comparison of the proportion of device/injection-related severe AEs in the MHGS Grade 4 (Group A) subjects versus the MHGS Grade 2-3 (Group B) subjects
time frame: 6 months

Eligibility Criteria

Male or female participants at least 22 years old.

Inclusion Criteria: 1. Has hands rating 2, 3, or 4 on the validated MHGS as determined by a live, masked evaluator. 2. Is at least 22 years of age. 3. Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study. 4. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits and meet all study requirements. Exclusion Criteria: 1. Was a participant in the Radiesse hands pre-market clinical study 2. Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands. 3. Has any medical condition with the potential to interfere with the study or increase the risk of AEs.

Additional Information

Official title Radiesse® Post Approval Safety Study For the Treatment of Hands With Moderate to Very Severe Dorsal Volume Loss
Description This is a 2-year post approval safety (PAS) study evaluating the Adverse Event (AE) rate of Merz Hand Grading Scale (MHGS) baseline grade 4 hands (Group A) compared to the AE rate of MHGS baseline grade 2-3 hands (Group B). Subjects will be recruited at each site with the intention to have an equal number of subjects in Group A and Group B. All subjects will receive an initial Radiesse hand treatment in both hands, and up to 3 retreatments in the study. Hands will be assessed by evaluators on the MHGS who will be blinded to group, treatment details, time since last treatment, and number of retreatments.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Merz Pharmaceuticals, LLC.