The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery
Phase: NA
Conditions: Skin Laxity, Lipodystrophy
Sponsor: Recros Medica, Inc.

Recros Medica - Confidential 
 
 
Protocol CLP-0007, Amendment 1 
17-May-2019 (FINAL) 
1 of 3 
 
CONFIDENTIAL - PROTOCOL 
The following contains confidential, proprietary information which is the property of Recros 
Medica 
The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy 
of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure 
Regimen for Accelerated Recovery  
 
Protocol Number:  
CLP-0007 
Version 
17-May-2019, Amendment 1 
Name of Investigational Product: 
Recros Medica Focal Contouring System 
Sponsor: 
Recros Medica, Inc. 
 
3525 Del Mar Heights Road, Suite 609 
 
San Diego, CA 92130a 
Emergency Telephone Number(s): 
714-309-7667 
Serious Adverse Event Reporting: 
rmcintosh@recrosmedica.com 
Recros Medica Safety Physician: 
Catherine Kusnick, MD 
Recros Medica Signatory: 
Robin McIntosh 
NCT Number: 
NCT03966924 
 

Recros Medica - Confidential 
 
 
Protocol CLP-0007, Amendment 1 
17-May-2019 (FINAL) 
2 of 3 
Investigational Device: 
 
Recros Medica Focal Contouring System to perform Rotational Fractional Resection (skin 
resection with and without and focal lipectomy) 
Study Objective: 
The objective is to explore and evaluate the peri-procedure treatment plan for accelerated 
recovery after Rotational Fractional Resection in patients with submental laxity.   
Study Design 
Structure: Prospective, single-center, exploratory, interventional cohort, non-significant risk 
(NSR) study.  
Duration: Approximately 4 months for each subject from the screening visit to the exit visit.  
Visit Schedule: Screening, procedure, Day 1, 4, 7, 14, 21, 30, 45, 60, and 90 post-procedure.  An 
optional visit may occur 5-6 days after procedure.  
Indication for Use: The Recros Medica focal contouring system is intended for resecting skin 
with and without fat removal for the purpose of submental contouring. 
Study Population Characteristics 
Number of Subjects:  Up to approximately 50 subjects will be enrolled (consented) to ensure up 
to approximately 30 subjects treated at 1 US site.  
Condition/Disease:  Adult subjects with moderate to severe submental laxity. 
Key Inclusion Criteria:  Healthy male or female, at least 30 years old; moderate to severe 
submental laxity; agree to maintain weight (±5%) for the duration of the study 
Key Exclusion Criteria:  History of psoriasis, hyperpigmentation, eczema, rosacea or vitiligo; 
history of keloids, hypertrophic scarring, or other skin condition that may result in excessive 
scarring; Fitzpatrick skin type 4, 5, and 6; severe or very severe lipodystrophy; body mass index 
>30 kg/m2; treatment with aspirin or aspirin containing products (e.g., Excedrin), NSAIDS, 
vitamin E within 14 days of the procedure. 

Recros Medica - Confidential 
 
 
Protocol CLP-0007, Amendment 1 
17-May-2019 (FINAL) 
3 of 3 
Response Measures 
Efficacy: 
 Submental Skin Laxity Scale, as assessed by the investigator 
 Submental Lipodystrophy Scale, as assessed by the investigator 
 Subject Satisfaction Questionnaire, as assessed by the subjects 
Safety: 
 Visual Skin Assessment in the procedure area, as assessed by the investigator 
 Visual Skin Assessment in procedure area by the subject 
 Adverse events  
 Manchester Scar Scale 
 Visible scarring  
 Pain assessment, using an 11-point Numeric Rating Scale (0 to 10), as assessed by the 
subject  
 Vital signs (blood pressure and pulse rate) 
Other: 
 Peri-procedure interventions 
 Elastic Adhesive Membrane Questionnaire 
 Weight  
 Photography  
Sample Size Calculation and Analysis Methods:  
Because this study is exploratory in nature, no sample size estimates have been performed.