Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Dermatology, Laser & Vein Specialists of the Carolinas
Sponsor:
Information provided by (Responsible Party):
Girish Munavalli, MD MHS, Dermatology, Laser & Vein Specialists of the Carolinas
ClinicalTrials.gov Identifier:
NCT01791660
First received: August 31, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

Protocol is intended for the clinical evaluation of fat reduction in male breasts (pseudogynecomastia) using the ZELTIQ Coolsculpting System. The ZELTIQ Coolsculpting system has received market clearance from the U.S.FDA for non-invasive fat layer reduction in the flanks, and is commercially available.

Primary study endpoint is changes in the shape and reduction of the fat in the breast as established by photographic imaging and ultrasound imaging of the treated area.

Secondary endpoints will provide supportive data to evaluate device performance (subject satisfaction & fat reduction measured with ultrasound).


Condition Intervention
Gynecomastia
Device: Zeltiq Coolsculpting System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeted Fat Reduction of Pseudogynecomastia in the Male Breast Using the ZELTIQ Coolsculpting System

Further study details as provided by Dermatology, Laser & Vein Specialists of the Carolinas:

Primary Outcome Measures:
  • reduction of the fat layer [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast.


Secondary Outcome Measures:
  • visual reduction of the fat layer [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Subject satisfaction measured by subject questionnaires.


Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zeltiq Coolsculpting System
non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
Device: Zeltiq Coolsculpting System
Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Detailed Description:

not desired

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • INCLUDED:

    1. Male subjects > 18 years of age and < 70 years of age.
    2. Subject has clearly visible, palpable, excess fatty tissue in their breast area, and minimal fibrous tissue.
    3. Subject has not had weight change exceeding 10 pounds in the preceding month.
    4. Subject agrees to maintain their weight (i.e., within +/- 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
    5. Subject has read and signed a written informed consent form.

      Exclusion Criteria:

      EXCLUDED:

    1. Subject has had a surgical procedure(s) in the area of intended treatment.
    2. Subject has had an invasive fat reduction procedure (e.g., liposuction or mesotherapy) in the area of intended treatment.
    3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment.
    4. Subject needs to administer, or has a known history of, subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
    5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
    6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
    7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
    8. Subject body mass index (BMI) exceeds 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
    9. Subject is taking or has taken diet pills or diet supplements within the past month.
    10. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
    11. Subject is unable or unwilling to comply with the study requirements.
    12. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
    13. Personal history of previous breast malignancy.
    14. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
    15. Subject is taking any medication which could cause abnormal breast enlargement - including but not limited to: digoxin, furosemide, gonadotropins, clomiphene, phenytoin, and exogenous testosterone, ketoconazole, metronidazole, alkylating agents, cisplatin, spironolactone, cimetidine, flutamide, finasteride, etomidate, isonicotinic acid hydrazide, methyldopa, busulfan, tricyclic antidepressants, diazepam, penicillamine, omeprazole, phenothiazines, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors.
    16. Recent history (within the past 5 years) of substance abuse (alcohol, marijuana or heroin).
    17. Subject has no history of the following medical conditions: Klinefelter syndrome, Congenital anorchia, Testicular trauma, Testicular torsion, Viral orchitis, Kallmann syndrome , Pituitary tumors, Malignancies that increase the serum level of hCG (eg, large cell lung cancer, gastric carcinoma, renal cell carcinoma, hepatoma), Renal failure, Hyperthyroidism, Malnutrition, Androgen insensitivity syndrome, Five-alpha-reductase deficiency syndrome
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791660

Contacts
Contact: Cindy L Tucker, RN CCRP 704-375-6766 ext 3537 nurse@carolinaskin.com
Contact: Razia Ludin, Research assistant 704-375-6766 ext 3606 razial@carolinaskin.com

Locations
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Cindy L Tucker, RN CCRP    704-375-6766 ext 3537    nurse@carolinaskin.com   
Contact: Razia Ludin, research assistant    704-375-6766 ext 3606    razial@carolinaskin.com   
Principal Investigator: Girish S Munavalli, MD MHS         
Sponsors and Collaborators
Dermatology, Laser & Vein Specialists of the Carolinas
Investigators
Principal Investigator: Girish S Munavalli, MD MHS Dermatology, Laser & Vein Specialists of the Carolinas
  More Information

Additional Information:
No publications provided

Responsible Party: Girish Munavalli, MD MHS, MD,MHS, Dermatology, Laser & Vein Specialists of the Carolinas
ClinicalTrials.gov Identifier: NCT01791660     History of Changes
Other Study ID Numbers: DLVSC-ZA-001
Study First Received: August 31, 2012
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gynecomastia
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014