Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Single-Center Investigator-Initiated Evaluator-Bilateral-Comparison Pilot Study of Injectable Calcium Hydroxylapatite With and Without Triamcinolone Acetate for the Treatment of Volume Loss to Dorsum Areas of the Hands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02454088
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Merz North America, Inc.
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Brief Summary:
This will be a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.

Condition or disease Intervention/treatment Phase
Volume Loss to Dorsum of Hands Other: Calcium Hydroxylapatite and Triamcinolone acetate Device: Calcium Hydroxylapatite and Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Active Comparator: Triamcinolone acetate
Injection of Calcium hydroxylapatite with Triamcinolone acetate
Other: Calcium Hydroxylapatite and Triamcinolone acetate
Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite

Placebo Comparator: Placebo
Injection of Calcium hydroxylapatite with a placebo
Device: Calcium Hydroxylapatite and Placebo
Calcium Hydroxylapatite and Placebo




Primary Outcome Measures :
  1. Efficacy Analysis (Merz Validated Hand Grading Score) [ Time Frame: Through day 360 ]
    The primary analyses of efficacy will be based on the change from Baseline through Day 360 for assessment (based on the Merz Validated Hand Grading Score).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Cutaneous and soft tissue atrophy in the dorsum of both hands, as indicated by the Merz Validated Hand Grading Scale score of 2, 3 or 4.
  2. Males or females in good general health who are 22 years of age or older.
  3. Must be willing to give and sign an informed consent form and photographic release form.
  4. Subject is planning re-volumizing rejuvenation treatment to the dorsum area of both hands.
  5. For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.

    A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.

    Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and/or vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually active.

  6. Negative urine pregnancy test results at the time of study entry (if applicable).
  7. Must be willing to comply with study dosing and complete the entire course of the study.

Exclusion Criteria:

  1. A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
  2. A Subject that is currently using systemic steroids.
  3. A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
  4. A subject with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
  5. A subject with an active bacterial, fungal, or viral infection in the treatment area.
  6. A subject with an active systemic fungal infection.
  7. A subject with a prior history of an allergy to any of the products or medications being used in the study.
  8. A subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator.
  9. A subject with a history of previous fat transfer or injectable poly-l-lactic acid to the study area within the past five years.
  10. A subject with a previous history of calcium hydroxylapatite to the treatment area within the past year.
  11. A subject with a previous history of ablative laser surgery to the treatment area within the past year.
  12. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.
  13. Subjects with known autoimmune disease or compromised immune systems i.e. HIV, AIDS or current chemotherapy.
  14. Subjects with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection per investigator discretion.
  15. Subjects with a history hypertrophic scarring.
  16. Subjects with a cancerous or precancerous lesion, or unhealed wound in the treatment area.
  17. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454088


Locations
Layout table for location information
United States, California
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
Merz North America, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Mitchel P Goldman, MD Cosmetic Laser Dermatology
Layout table for additonal information
Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT02454088    
Other Study ID Numbers: RAD-2010
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Goldman, Butterwick, Fitzpatrick and Groff:
Volume
Hands
Filler
Radiesse
Calcium hydroxylapatite
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcium, Dietary
Triamcinolone
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists