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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01791660
Other study ID # DLVSC-ZA-001
Secondary ID
Status Recruiting
Phase N/A
First received August 31, 2012
Last updated February 12, 2013
Start date August 2012
Est. completion date April 2013

Study information

Verified date February 2013
Source Dermatology, Laser & Vein Specialists of the Carolinas
Contact Cindy L Tucker, RN CCRP
Phone 704-375-6766
Email nurse@carolinaskin.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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).


Description:

not desired


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Zeltiq Coolsculpting System
Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

Locations

Country Name City State
United States Dermatology, Laser & Vein Specialists of the Carolinas Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Dermatology, Laser & Vein Specialists of the Carolinas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduction of the fat layer Visual, photographic and ultrasound measured changes in the shape and reduction of the fat in the male breast. 8 months No
Secondary visual reduction of the fat layer Subject satisfaction measured by subject questionnaires. 8 months No
See also
  Status Clinical Trial Phase
Completed NCT05093049 - Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery N/A
Completed NCT03319862 - Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction N/A
Withdrawn NCT02711605 - UltraShape Device for Non-Invasive Fat Reduction in the Male Breast (Pseudogynecomastia) N/A
Completed NCT00241436 - Open Label Arimidex in Gynecomastia Phase 2
Completed NCT04425447 - Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery N/A
Completed NCT00637182 - Gynecomastia Extension Study Phase 3
Recruiting NCT04836364 - Skincare Products and Environmental Health
Active, not recruiting NCT04966078 - Treatment of Mild and Moderate Cases of Gynaecomastia N/A
Completed NCT04063722 - Modified Benelli Procedure For Subcutaneous Mastectomy N/A
Not yet recruiting NCT06070324 - Effect of Suture Material on Postoperative Nipple Areolar Complex Widening N/A
Withdrawn NCT04321967 - Nitropaste in Breast Reduction Phase 3

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