Radiological Evaluation of Radiesse Implantation in the Hands

NCT02949921 | Completed Results

• 1 other identifier: P151010, M900311003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to provide a preliminary assessment of the radiographic appearance of Radiesse material that has been injected into the dorsum of the hands.

Conditions

Volume Loss in the Dorsum of the Hand

Outcome Measures

Primary Outcomes (4)

• Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1

  Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

  Month 1

• Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6

  Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

  Month 6

• Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12

  Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

  Month 12

• Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24

  Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.

  Month 24

Secondary Outcomes (6)

• Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6

  Months 1 and 6

• Michigan Hand Outcomes Questionnaire (MHQ) Scores

  Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24

• Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6

  Months 1 and 6

• Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12

  Months 7 and 12

• Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6

  Months 1 and 6

Study Arms (2)

"Grade 4 Hands" group

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.

Device: Radiesse injectable implant and 2% lidocaine HCL

"Grade 2 or 3 Hands" group

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.

Device: Radiesse injectable implant and 2% lidocaine HCL

Interventions

Radiesse injectable implant and 2% lidocaine HCL DEVICE

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.

"Grade 2 or 3 Hands" group; "Grade 4 Hands" group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has hands rating 2, 3, or 4 on the validated Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator.
• Is at least 22 years of age.
• Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through the end of the study.

You may not qualify if:

• Was a participant in the Radiesse hands pre-market clinical study.
• Has been treated with fat injections or Radiesse in the hands, has hand deformities, or has received surgery in the dorsum of the hands.
• Has any medical condition with the potential to interfere with the study or increase the risk of adverse events (AEs).

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (1)

Merz Investigative Site #0010358

Vista, California, United States

Location

Related Publications (1)

• Moradi A, Ethakovic R, Odena G. Aesthetic Implantation of Calcium Hydroxylapatite Does Not Interfere With Radiological Assessment of Bones in the Dorsum of the Hands. Aesthet Surg J. 2023 May 15;43(6):696-703. doi: 10.1093/asj/sjac344.

  PMID: 36573029 BACKGROUND

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.de

+49 69 1503 1

Study Officials

• Peter Kreymerman, MD,FACS

  Study Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: October 31, 2016
• Study Start: December 1, 2015
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: November 29, 2023
• Results First Posted: March 14, 2019

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)