The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
Phase: NA
Conditions: Skin Laxity, Lipodystrophy
Sponsor: Recros Medica, Inc.

Recros Medica - Confidential 
 
 
Protocol CLP-0002, Amendment 3 
18-OCT-2018 (FINAL) 
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CONFIDENTIAL - PROTOCOL 
The following contains confidential, proprietary information which is the property of Recros 
Medica 
The CONFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational 
Fractional Resection on Submental Contouring 
 
Protocol Number:  
CLP-0002 
Version 
18-October-2018 (Amendment 3) 
Name of Investigational Product: 
Recros Medica Focal Contouring System 
Sponsor: 
Recros Medica, Inc. 
 
3525 Del Mar Heights Road, Suite 609 
 
San Diego, CA 92130a 
NCT Number 
NCT03407313 
 

Recros Medica - Confidential 
 
 
Protocol CLP-0002, Amendment 3 
18-OCT-2018 (FINAL) 
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Investigational Device: 
 
Recros Medica Focal Contouring System to perform Rotational Fractional Resection (skin 
resection and focal lipectomy) 
Study Objective: 
The objective is to evaluate the efficacy and safety of using Rotational Fractional Resection in 
improving submental contouring.   
Clinical Hypotheses: 
Primary Efficacy: 
Removal of skin and fat using Rotational Fractional Resection will result in a noticeable 
improvement of submental contour, as determined by a mean 0.75 grade improvement on either 
the Submental Skin Laxity Scale or Submental Lipodystrophy Scale. 
Primary Safety: 
Post-procedure scarring will be assessed using the Manchester Scar Scale. 
Study Design 
Structure: Prospective, multi-center, single-arm (non-randomized), interventional cohort, non-
significant risk (NSR) study  
Duration: Approximately 7 months for each subject from the screening visit to the exit visit.  
Visit Schedule: Screening, procedure, Day 1, 7, 14, 30, 90 and 180 post-procedure.  
Indication for Use: The Recros Medica focal contouring system is intended for resecting skin 
and removing fat for the purpose of focal aesthetic contouring of the submentum. 
Study Population Characteristics 
Number of Subjects:  Up to approximately 110 subjects will be enrolled into this study to ensure 
up to approximately 70 subjects treated at approximately 4-8 investigational sites in the US to 
ensure that there are at least 55 evaluable subjects. 

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Protocol CLP-0002, Amendment 3 
18-OCT-2018 (FINAL) 
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Condition/Disease:  Adult subjects with mild to moderate submental fat and mild to moderate 
submental skin laxity. 
Key Inclusion Criteria:  Healthy male or female, at least 30 years old; mild to moderate 
submental lipodystrophy; mild to moderate submental skin laxity; Fitzpatrick skin phototype 1, 2 
or 3; agree to maintain weight (5%) for the duration of the study 
Key Exclusion Criteria:  History of any intervention to treat submental fat or skin laxity (e.g., 
liposuction, surgery, chemical lipolysis, cryolipolysis); history of psoriasis, hyperpigmentation, 
eczema, rosacea or vitiligo; history of keloids, hypertrophic scarring, or other skin condition that 
may result in excessive scarring; history of folliculitis in hirsute areas; 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. 
Response Measures 
Primary Efficacy: 
 Submental Skin Laxity Scale, as assessed by independent raters  
 Submental Lipodystrophy Scale, as assessed by independent raters 
Secondary Efficacy: 
 Submental Skin Laxity Scale, as assessed by the investigator 
 Submental Lipodystrophy Scale, as assessed by the investigator 
 Subjects with at least a 1-point improvement on the Submental Skin Laxity or 
Lipodystrophy Scales, as assessed by independent raters 
 Subject Satisfaction Questionnaire, as assessed by the subjects 
 Image Analysis (IA) of facial photography for skin laxity 
 Pre- and post-procedure photography comparison, as assessed by independent raters  
Primary Safety: 
 Manchester Scar Scale 

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Protocol CLP-0002, Amendment 3 
18-OCT-2018 (FINAL) 
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Secondary Safety: 
 Adverse events  
 Visible scarring  
 Visual skin assessment in procedure area by the investigator and the subject 
 Pain assessment, using an 11-point Numeric Rating Scale (0 to 10), as assessed by the 
subject  
 Vital signs (blood pressure and pulse rate) 
Sample Size Calculation and Analysis Methods:  
The sample size calculation is based on two t-tests of the hypotheses for the primary efficacy 
endpoints.  One endpoint is the change in the Skin Laxity Scale from baseline to 90 days; the 
other is the change in the Skin Lipodystrophy Scale from baseline to 90 days.  The null 
hypotheses are that there is no change in the scale scores.  The alternative hypotheses is that 
there is a change of at least 0.75 points on at least one scale.  The endpoint is a composite 
endpoint of the two, with the requirement for passing the Primary Efficacy Hypothesis that at 
least one of the null hypotheses be rejected. 
Assuming that the true change is 1.0 points on each test, and that the standard deviation (SD) is 
0.7 points, the sample size required for combined power of 91% and Type 1 error of 5% is 55.  
The sample size calculation was done with PASS 141 for an inequality test of one mean. 
To accommodate approximately 10% attrition, the number of subjects undergoing the procedure 
will be 55/.9 ≈ 60.  
 
 
 
1  
PASS 14 Power Analysis and Sample Size Software (2015). NCSS, LLC. Kaysville, Utah, USA, 
ncss.com/software/pass.