Trial record 1 of 1 for:
Recros Medica
CONFORM: Rotational Fractional Resection for Submental Contouring
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| ClinicalTrials.gov Identifier: NCT03407313 |
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Recruitment Status :
Recruiting
First Posted : January 23, 2018
Last Update Posted : August 13, 2018
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Sponsor:
Recros Medica, Inc.
Information provided by (Responsible Party):
Recros Medica, Inc.
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Brief Summary:
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Skin Laxity Lipodystrophy | Device: Rotational fractional resection | Not Applicable |
This is a prospective, multi-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 mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring |
| Actual Study Start Date : | January 8, 2018 |
| Estimated Primary Completion Date : | January 2019 |
| Estimated Study Completion Date : | April 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Cutis laxa
| Arm | Intervention/treatment |
|---|---|
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Experimental: Rotational fractional resection
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
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Device: Rotational fractional resection
Single treatment of skin resection and focal lipectomy (removal of loose skin and fat) |
Primary Outcome Measures :
- Improved Submental Contouring [ Time Frame: Pre-treatment and 90 days after treatment ]Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects
Secondary Outcome Measures :
- Improved Skin Laxity [ Time Frame: Pre-treatment and 90 days after treatment ]One grade or better reduction in score on Submental Skin Laxity (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
- Improved Lipodystrophy [ Time Frame: Pre-treatment and 90 days after treatment ]One grade or better reduction in score on Submental Lipodystrophy Scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
- Subject Satisfaction [ Time Frame: 90 days after treatment ]Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female, at least 30 years old
- Moderate submental (neck) fat
- Mild to moderate submental (neck) skin laxity (loose skin)
- Willing and able to provide informed consent
- Willing and able to comply with all protocol requirements
- Willing to limit direct sun exposure and use sunscreen for duration of the study
- Agree to maintain weight for duration of the study
- Willing to have photographs taken that could identify the participant
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
- Sensitivity to local anesthesia
- Severe acne, cystic acne or acne scars on neck
- Trauma of chin or neck area
- Skin infection or rash on neck
- Psoriasis, eczema, rosacea, or vitiligo
- History of scarring
- History or current symptoms of dysphagia
- Chronic or persistent coughing
- Body mass index (BMI) > 30
- Clinically significant bleeding disorder
- Anemia, kidney disease, or liver disease
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): NCT03407313
Contacts
| Contact: Robin McIntosh | 714-309-7667 | rmcintosh@recrosmedica.com |
Locations
| United States, California | |
| Aesthetx | Recruiting |
| Campbell, California, United States, 95008 | |
| Contact: Janelle Lee, RN, BSN 408-559-7117 janelle@aesthetx.com | |
| Principal Investigator: Kamakshi R Zeidler, MD | |
| Sub-Investigator: R Laurence Berkowitz, MD | |
| Sub-Investigator: Amelia Hausauer, MD | |
| Steve Yoelin, MD Medical Associates, Inc. | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Jo Lee 949-548-2711 auxiliary2@aol.com | |
| Contact: Thao Le 949-548-2711 letn89@gmail.com | |
| Roseville Facial Plastic Surgery | Recruiting |
| Roseville, California, United States, 95661 | |
| Contact: Elizabeth Langlois 916-773-0395 Elizabeth.rfps@gmail.com | |
| Contact: Kathy Kettenhofen, CCMA 916-773-0395 kkettenhofen@sacent.com | |
| Principal Investigator: Jonathan M Sykes, MD | |
| Sub-Investigator: David J Kiener, MD | |
| United States, Florida | |
| Miami Dermatology & Laser Institute | Recruiting |
| Miami, Florida, United States, 33173 | |
| Contact: Nicole Rieth 305-279-6060 NicoleR@miamidermlaser.com | |
| Principal Investigator: Jill S Waibel, MD | |
| United States, Illinois | |
| DeNova Research | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Selika Gutierrez- Borst, MS, RN 312-335-2070 selika@denovaresearch.com | |
| Contact: Nimit Gandhi, MD 312-335-2070 Nimit@Denovaresearch.com | |
| Principal Investigator: Steven H Dayan, MD | |
| United States, Minnesota | |
| Zel Skin & Laser Specialists | Recruiting |
| Edina, Minnesota, United States, 55424 | |
| Contact: Mona Selim 952-929-8888 mona.selim@unitedskin.com | |
| Principal Investigator: Brian Zelickson, MD | |
| Sub-Investigator: Karl Vance, MD | |
| United States, Virginia | |
| Sundaram Dermatology, Cosmetic & Laser Surgery Center | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Vidya Srinivasan 703-641-9666 vidyals@gmail.com | |
| Principal Investigator: Hema Sundaram, MD | |
Sponsors and Collaborators
Recros Medica, Inc.
Investigators
| Study Director: | Edward W Knowlton, MD | Recros Medica, Inc. |
| Responsible Party: | Recros Medica, Inc. |
| ClinicalTrials.gov Identifier: | NCT03407313 History of Changes |
| Other Study ID Numbers: |
CLP-0002 |
| First Posted: | January 23, 2018 Key Record Dates |
| Last Update Posted: | August 13, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | No | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by Recros Medica, Inc.:
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Submental fullness Submental fat Loose skin |
Additional relevant MeSH terms:
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Lipodystrophy Cutis Laxa Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders |
Metabolic Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Connective Tissue Diseases |