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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03966924
Other study ID # CLP-0007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2019
Est. completion date October 16, 2019

Study information

Verified date January 2020
Source Recros Medica, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.


Description:

This is a prospective, single-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date October 16, 2019
Est. primary completion date October 16, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Healthy male or female - At least 30 years old - Moderate to severe submental laxity - Up to moderate submental lipodystrophy - Agree to maintain weight (±5%) for the duration of the study Exclusion Criteria: - Previous intervention to treat submental fat or skin laxity - Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure - Severe acne, cystic acne or acne scars on neck - Trauma of chin or neck area - Skin infection or rash on neck - Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo - History of scarring - Body mass index (BMI) >30 - Clinically significant bleeding disorder - Anemia, kidney disease, or liver disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rotational fractional resection (1.5mm Diameter Device)
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Locations

Country Name City State
United States Steve Yoelin, MD Medical Associates, Inc. Newport Beach California

Sponsors (1)

Lead Sponsor Collaborator
Recros Medica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) 90 days post treatment
Secondary Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied"). 90 days post treatment
Secondary Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) 90 days post treatment
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