Conditions: Facial Volume Loss
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: yes

Brief summary:
This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.

Detailed description:
Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.

Arms:
arm 1: Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects

Interventions: intervention 1: Poly-L-Lactic Acid (Sculptra) injection
Intervention descriptions: intervention 1: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject.

Protocol document:
Prot_SAP_000.pdf: 
 
 
1 
October 21, 2015 
PROTOCOL 
The Emotional and Functional Benefits of Poly-L-Lactic Acid 
YDA-001 
 
 
Study Sponsor: 
Yardley Dermatology Associates, PC 
Yardley Clinical Research Associates  
903 Floral Vale Blvd. 
Yardley, PA 19067 
 
Principal Investigator 
Richard Fried, MD, PHD 
Sub-Investigators 
William Philip Werschler, MD (Spokane Dermatology) 
Lauren Sternberg, MD (Yardley Dermatology Associates) 
Judi Cenci, MD (Yardley Dermatology Associates) 
Priya Dhanaraj, MD (Yardley Dermatology Associates) 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
2 
October 21, 2015 
PROTOCOL APPROVAL PAGE 
 
INVESTIGATOR SIGNATURE PAGE 
 
 
I agree to: 
● Implement and conduct this study diligently and in strict compliance with the protocol, good clinical 
practices and all applicable laws and regulations. 
● Maintain all information supplied by Yardley Dermatology Associates, PC, Yardley Clinical Research 
Associates or its designate in confidence and, when this information is submitted to an Institutional Review 
Board (IRB)or another group, it will be submitted with a designation that the material is confidential. 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
Investigator Printed Name 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
3 
October 21, 2015 
 
STUDY  PERSONNEL  CONTACT  INFORMATION 
Sponsor-Investigator Contact 
Richard G Fried, MD, PhD 
Yardley Dermatology Associates. PC 
Yardley Clinical Research Associates 
903 Floral Vale Blvd 
Yardley, PA 19067 
Phone:  215 579-6155 
Email:  Dermshrink@gmail.com 
 
Principal Investigators 
Richard Fried, MD.PHD 
Yardley Dermatology Associates. PC 
Yardley Clinical Research Associates 
903 Floral Vale Blvd 
Yardley, PA 19067 
 
William Philip Werschler 
Spokane Dermatology-Werschler Aesthetics 
324 South Sherman Street 
 Spokane WA 99202 
 
 
Sub-Investigators 
 
Lauren Sternberg, MD (Yardley Dermatology Associates, 903 Floral Vale Blvd,, Yardley PA 19067) 
Judi Cenci, MD (Yardley Dermatology Associates, 903 Floral Vale Blvd,, Yardley PA 19067) 
Priya Dhanaraj, MD (Yardley Dermatology Associates, 903 Floral Vale Blvd,, Yardley PA 19067) 
Email:  Dermshrink@gmail.com 
 
Clinical Trials Coordinator 
 
Michelle Sibona 
Yardley Dermatology Associates, PC 
Yardley Clinical Research Associates 
903 Floral Vale Blvd 
Yardley, PA 19067 
Phone:  215 579-6155 x27 
Email:  Michelle903@comcast.net  
 
 
 


 
 
4 
October 21, 2015 
 
 
TABLE OF CONTENTS 
PROTOCOL APPROVAL PAGE 
 
1 
INVESTIGATOR SIGNATURE PAGE 
 
2 
STUDY PERSONNEL CONTACT INFORMATION 
 
3 
GLOSSARY OF ABBREVIATIONS 
 
5 
PROTOCOL SYNOPSIS 
 
6 
1. 
BACKGROUND AND RATIONALE 
 
7 
2. 
CURRENT CLINICAL STUDY 
 
7 
3. 
OBJECTIVES 
 
7 
4. 
STUDY DESIGN 
 
7 
5. 
STUDY POPULATION 
 
8 
 
5.1 NUMBER OF SUBJECTS 
 
 
 
 
 
 
             
8 
          
5.2 INCLUSION CRITERIA 
 
 
 
 
 
 
              
8 
          
5.3 EXCLUSION CRITERIA 
 
 
 
 
 
 
              
8 
6. 
ENROLLMENT  
 
8 
7.         INFORMED CONSENT AND SUBJECT PRIVACY 
 
 
 
 
             
8 
8. 
STUDY ASSESSMENTS 
 
9 
   
8.1 ACNE SCAR RATING SCALE  
 
 
 
 
 
              
9 
         
8.2 SUBJECT SELF-REPORT INSTRUMENT 
 
 
 
 
             
9 
 
8.3 PHOTOGRAPHY 
 
 
 
 
 
 
 
              
9 
9. 
SCHEDULE OF STUDY ACTIVITIES 
 
10 
10. 
EARLY DISCONTINUATION/WITHDRAWAL 
 
11 
11. 
COMPLIANCE WITH PROTOCOL 
 
11 
 
12.       STUDY TERMINATION 
 
11 
13.       GENERAL STATISTICAL ANALYSIS METHODS 
 
 
 
 
           
 
11 
14. 
ADMINISTRATIVE ISSUES 
 
11 
 
14.1         PROTECTION OF HUMAN SUBJECTS 
 
 
 
 
           
 
11 
14.1.1 
COMPLIANCE WITH INFORMED CONSENT REGULATIONS (21 CFR PART 50) 
 
11 
14.1.2 
COMPLIANCE WITH INSTITUTIONAL REVIEW BOARD REGULATIONS (21 CFR PART 56) 
11 
14.1.3 
COMPLIANCE WITH THE PRINCIPLES OF GOOD CLINICAL PRACTICE (ICH E6) 
 
12 
    14.2        SUBJECT CONFIDENTIALITY 
 
12 
14.2.1 
SUBJECT PRIVACY 
 
12 
    14.3        REQUIRED REGULATORY DOCUMENTS 
 
12 
14.3.1 
SOURCE DOCUMENTS 
 
12 
14.3.2 
CASE REPORT FORM (CRF) COMPLETION 
 
13 
14.3.3 
RETENTION OF DOCUMENTATION 
 
13 
14.4 
PROPRIETARY INFORMATION 
  
13 
14.5 
PUBLICATIONS 
 
14 
14.9 
REFERENCES 
 
15 
 
 
 
APPENDICES 
 
 
APPENDIX 1: Facial Volume Restoration Outcome Questionnaire 
 
1 
APPENDIX 2: Investigator Global Assessment (iga) of Facial Volume Loss 
 
3 
APPENDIX 3: Rosenberg Self-Esteem Scale 
 
 
 
 
 
 


 
 
5 
October 21, 2015 
 
 
GLOSSARY OF ABBREVIATIONS 
 
CFR 
U. S. Code of Federal Regulations 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practices 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB 
Independent Review Board 
PP 
Per protocol 
WHOdd 
World Health Organization Drug Dictionary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
6 
October 21, 2015 
 
 
PROTOCOL SYNOPSIS 
Title 
The Emotional and functional benefits of Poly-L-Lactic Acid 
Study Objective 
To assess the emotional and functional benefits of Poly-L-Lactic Acid injections in 
the face 
Study Population 
Male and female subjects >35 years of age. 
Study Design  
Cross-sectional, multicenter trial. 
Number of Sites 
2 sites. 
Total Number of 
Subjects 
50 subjects. 
Duration of Study 
6 months. 
Inclusion Criteria 
1. Subject must be an outpatient, male or female subjects of any race, 35 years of 
age or older.   
2. Subjects must have no evidence of clinically moderate to severe active acne 
activity or significant infectious process in the 6 months prior to study initiation.  
3. Subjects of all Fitzpatrick skin types are eligible. 
4. Subject must be able to follow study instructions and likely to complete all 
required visits, as assessed by the Investigator. 
5. Subject must sign an IRB-approved Informed Consent form, Photographic 
Release Form, and the Authorization for Use and release of Health and 
Research Study Information (HIPAA) form prior to any study-related procedures 
being performed. 
Exclusion Criteria 
1. Any of the previous facial treatments: 
a. Any facial filler in the past 2 years  
b. Prior injection of permanent facial implant 
2. Have any skin pathology or condition that could interfere with the evaluation of 
the face. 
3. Be unable to communicate or cooperate with the Investigator due to a language 
barrier (non-English speaking), poor mental development, or impaired cerebral 
function.  
4. Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor 
cooperation, non-compliance with medical treatment, or unreliability. 
5. Have used an investigation device, biologic or drug in the past 30 days, or be 
currently participating in an experimental drug, biologic or device trial. 
6. Have a condition or be in a situation that, in the Investigator's opinion, may put 
the subject at significant risk, may confound the study results, or may interfere 
significantly with the subject's participation in the study. 
7. Be an employee (or a relative of an employee) of the Investigator, Sponsor or 
representative of the Sponsor. 
 
Study 
Measurements 
Subject self-reported quality of life scale 
Study Procedures 
and Assessment 
Schedule 
Eligible subjects will be given a self report questionnaire to complete 1 month after 
their second or third injection while in the physician’s office. A subset of subjects will 
have baseline and post injection photographs taken.  
Statistical 
Methods  
Data will be summarized using descriptive statistics. 


 
 
7 
October 21, 2015 
 
 
1. 
Background and Rationale 
 
Facial volume loss can substantially impact both self perception of the affected individual and their social/professional 
interactions and opportunities. Persons who are perceived as more youthful and attractive are rated as nicer, more 
energetic, healthier, and more likely to be productive than those perceived to be older and unattractive. 
The observed facial changes that result from underlying volume loss often produce an older and less attractive 
appearance. Loss of facial volume often produces a sad, sunken, deflated, dull, tired, and lackluster appearance. These 
changes can be interpreted as evidence of aging and loss. In addition, some may consciously or subconsciously see them 
as harbingers of progressive deterioration and decline. Filler correction of localized areas of facial volume loss has been 
demonstrated to affect positive changes in emotional and functional status by patient self report measures. 
 
2. 
Current Clinical Study 
A concern among some clinicians is the “delayed gratification” aspect of poly L-Lactic Acid.  While its efficacy, 
safety, and duration of benefit are well supported by the literature, it is unique as a biostimulator leading to the 
gradual onset of tissue augmentation over several months. Many clinicians wonder whether patients will 
objectively “remember” their baseline appearance and thus be satisfied with their ultimate cosmetic outcome. 
The goal of this study is to assess both the short term and longer term (3 months post first injection and 6 
months post first injection) satisfaction with facial volume restoration  with poly L-Lactic Acid.  
 
Specifically, a patient self report questionnaire, previously utilized in several facial filler studies, will be completed by study 
participants at 3 months and six months after their initial facial injections to assess the emotional and functional effects 
produced by pan facial treatment with Poly-L-Lactic Acid. The obtained data will hopefully further enhance our 
appreciation and understanding of the benefits of facial volume restoration. Insight will hopefully be provided into the 
benefits of gradual onset of volumization with prolonged duration of improvement. 
. 
Buttressing and clarifying the data on the emotional and functional benefits of facial volume restoration can 
further “legitimize” treatment with poly L-Lactic Acid as an effective and meaningful medical procedure. 
Dissemination of data substantiating that volume restoration is more than simply a vanity or cosmetic 
intervention can serve as a compelling “recruitment tool” for the growing number of “maturing persons” 
struggling with the deflation and lackluster appearance that accompany the volume loss associated with aging, 
medications, stress, and illness. 
 
 
3. 
Objectives 
Objective 1: To assess the emotional and functional improvement produced by pan facial improvement with Poly-L-Lactic 
Acid 
Objective 2: To assess to stability of these affects after treatment 
 
Objective 3: To further substantiate the legitimacy and value of facial volume restoration. 
 
 
4. 
Study Design 
This is a multi-center study utilizing 2 centers (Yardley Dermatology Associates, 903 Floral Vale Blvd., Yardley PA 19067 
and Spokane Dermatology-Werschler Aesthetics, 324 South Sherman Street, Spokane WA 99202. Subjects will be 
recruited from private practice dermatology offices. Eligible patients must meet the inclusion and exclusion criteria as 
stated below. 


 
 
8 
October 21, 2015 
 
5. 
Study Population 
 
5.1 
Number of Subjects 
50 male and/or female subjects 35 years of age or older who meet the protocol’s participant eligibility 
requirements will be enrolled in the study at 2 investigational sites.   
Study sites will be selected on the basis of experience in facial volume restoration and anticipated subject 
enrollment rate, with the objective of completing enrollment within approximately 2 months. 
 
5.2 
Inclusion Criteria 
1. Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.   
2. Subject must have any degree of facial volume loss. 
3. Subjects of all Fitzpatrick skin types are eligible. 
4. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the 
Investigator. 
5. Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the 
Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-
related procedures being performed. 
 
5.3        Exclusion Criteria 
1. Any of the previous facial treatments: 
c. Any facial filler in the past 2 years  
d. Prior injection of permanent facial implant 
2. Have any skin pathology or condition that could interfere with the evaluation of the face. 
3. Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English 
speaking), poor mental development, or impaired cerebral function.  
4. Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-
compliance with medical treatment, or unreliability. 
5. Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in 
an experimental drug, biologic or device trial. 
6. Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant 
risk, may confound the study results, or may interfere significantly with the subject's participation in the 
study. 
7. Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the 
Sponsor. 
 
6. 
Enrollment 
Subjects will have the study explained and will be asked about their willingness to participate, including their willingness to 
sign an informed consent and a photography release form. To comply with Health Insurance Portability and Accountability 
Act (HIPAA) requirements, a separate authorization for disclosure or use of protected health information will be signed.  
After full consent, subjects will be considered enrolled into the study.   
7. 
Informed Consent and Subject Privacy 
The purpose and procedures to study participation will be discussed with each potential subject.  Prior to any study-
related procedures subjects must give their written informed consent.  The subject must also give Authorization for Use 
and Release of Health and Research Study Information (HIPAA), authorization to take identifying clinical photographs for 
scientific and regulatory use and other written documentation required by local regulations and/or the reviewing IRB prior 
to any study-related procedures. 
 
 


 
 
9 
October 21, 2015 
8. 
Study Assessments 
Prior to enrollment of any study subjects, the Investigators will be trained in the use of the assessment scale. Subjects will 
receive training on how to complete the Volume Restoration Quality of Life Scale.. 
 
The Sponsor will prepare written procedures on how to perform digital imaging in a standardized fashion.   
 
8.1 
Investigator Global Assessment (IGA) of Facial Volume Loss 
Grade 
Description  
0 
No visible volume loss 
1 
Mild volume loss. 
2  
Moderate volume loss 
3  
Severe volume loss 
4 
Very severe volume loss 
 
 
 
8.2 
Subject Self- Report Quality of Life Instrument 
 
A subject self-report instrument with 35 questions will be distributed to the subject for completion at the study site. 
This questionnaire is designed to assess the emotional and functional impact of facial acne scarring. 
 
8.3 Photography 
Photographs for the study may be taken only at an investigators site as designated by the sponsor. Written 
training regarding study related photography will be provided during site initiation visits (where applicable).   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
10 
October 21, 2015 
9. 
Schedule of Study Activities 
 
 
Subjects must meet all screening criteria as assessed by subject interview and through examination of facial volume loss. 
Please refer to the following schedule for additional details: 
 
1. Discuss with each subject his/her willingness to participate in the study and obtain Informed Consent/HIPAA. 
2. Inclusion/Exclusion Criteria 
3. Document Subject Demographic Information 
4. Subject Photography 
a. To be conducted at baseline prior to first injection and 3 month and 6 month post initial injection.  
Photography instructions to be provided in a separate study document. 
5. Facial volume loss assessment by Investigator and subject 
a. Investigator/Subject Facial Volume Loss Global Assessment   
6. Subjects will receive 1 vial of poly-L-lactic acid reconstituted in the usual sterile fashion with 7cc of sterile 
water and 2cc of Lidocaine without epinephrine.  The contents of the vial will be injected as deemed 
appropriate by the certified injector and agreed upon by the study subject. 
7. Approximately 4-6 weeks later, a second vial will be reconstituted as above and injected according to the 
above parameters. 
8. Approximately 4-6 weeks later (8-12 weeks after the first injections), subjects will be evaluated and a decision 
jointly made with the injector regarding whether a third vial is desired and appropriate. 
9. Injection sites will be prepared in the usual sterile fashion and sites will have Lidocaine topical application 30-
90 minutes before the procedure. 
10. All subjects will receive full informed consent and will have time for any questions before procedures are 
initiated. 
11. Explicit post procedure instructions will be provided as per usual protocol. 
12. Subjects will be instructed to contact the study site immediately with any concerns after each injection 
session. 
13. QOL and Self-Esteem measures by subject 
a.     To be completed 3months and 6 months post initial injection.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
11 
October 21, 2015 
10. 
Early Discontinuation/Withdrawal 
It is the right and duty of the Investigator to discontinue a subject’s participation when the subject's health or well-being is 
threatened by continuation in the study. Such subjects should be withdrawn from the study.  In the event of premature 
discontinuation, the Investigator should determine the primary reason for discontinuation.    Subjects may voluntarily 
withdraw from the study at any time without jeopardy to future medical care. For any subject who withdraws from the 
study the date and reason for withdrawal will be recorded on the CRF.   
 
11. 
Compliance with Protocol 
The Investigator is responsible for compliance with the protocol at the investigational site.  A representative of the 
Sponsor will make contact with the Investigator and his/her research staff to obtain completed CRFs. 
 
 
12. 
Study Termination 
 
If conditions arise during the study that indicate that the study or an investigational site should be terminated, the Sponsor, 
Investigator, Monitor, IRB, and/or regulatory agencies will discuss the situation and take appropriate action after 
consultation.   
 
Conditions warranting termination of the study or site include, but are not limited to: 
▪ 
The decision on the part of the Sponsor to suspend or discontinue evaluation, or development of the study. 
▪ 
Failure of the Investigator to comply with pertinent national or state regulations, IRB-imposed conditions, or 
protocol requirements; 
▪ 
Submission of knowingly false information from the Investigator to the Sponsor, IRB, or any regulatory agency. 
 
 
13. 
General Statistical Analysis Methods 
Relevant subject information i.e. demographics, facial volume restoration questionnaire answers will be collected and 
analyzed. This data will be summarized using descriptive statistics. 
 
 
14. 
Administrative Issues 
This protocol will be conducted in accordance with the applicable U.S. Food and Drug Administration (FDA) regulations 
and guidelines and Good Clinical Practice (GCP), i.e., the International Conference on Harmonization (ICH) Guideline on 
Good Clinical Practice. 
 
14.1 
Protection of Human Subjects 
14.1.1 Compliance with Informed Consent Regulations (21 CFR Part 50) 
Written informed consent will be obtained from each subject prior to enrollment into the study, i.e., before performing any 
screening evaluations or questionnaire completion.   
 
 
14.1.2 Compliance with Institutional Review Board Regulations (21 CFR Part 56) 
This study will be conducted in accordance with IRB regulations (U.S. 21 CFR Part 56.103).  The Investigator must obtain 
approval from a properly constituted IRB prior to initiating the study.  Yardley Clinical Research Associates is to be notified 
immediately if the responsible IRB has been disqualified or if proceedings leading to disqualification have begun. 
 


 
 
12 
October 21, 2015 
14.1.3 Compliance with the Principles of Good Clinical Practice (ICH E6) 
This protocol will be conducted in accordance with the applicable Good Clinical Practice (GCP) regulations and guidelines 
(ICH E6). 
 
No amendments to the protocol will be implemented without the prior written consent of the Sponsor. Should an 
amendment be necessary, the reviewing IRB may require review and approval prior to implementation. 
 
 
 
14.2 
Subject Confidentiality 
A report of the results of this study may be published, but the subject’s name will not be disclosed in this document.  The 
subject's name may be disclosed to the Sponsor of the study (Yardley Clinical Research Associates), the governing health 
authorities, or the FDA (U.S. Food and Drug Administration) if they inspect the study records.  Appropriate precautions will 
be taken to maintain confidentiality of medical records and personal information. 
 
14.2.1 Subject Privacy 
Written authorization will be obtained from each subject prior to enrollment into the study in accordance with the 
applicable privacy requirements [e.g., the Health Insurance Portability and Accountability Act Standards for Privacy of 
Individually Identifiable Health Information (“HIPAA”)].  
 
14.3 
Required Regulatory Documents 
It is the responsibility of the Investigator and study staff to maintain a comprehensive and centralized filing system of all 
study-related documentation, which is suitable for inspection at any time either by the IRB or FDA  .  Elements should 
include: 
 
● 
Subject files containing the completed case report forms, supporting source documentation and the informed 
consent, with signatures by the Investigator or sub-Investigators. 
● 
Confidential disclosure agreement with the sponsor. 
● 
Financial disclosure forms for each Investigator or sub-Investigator. 
● 
Study files, containing the following required documentation: 
- 
Protocol with all amendments 
- 
Copies of all pre-study documentation and all correspondence to and from the IRB and the sponsor or sponsor 
representatives 
- 
An up-to-date curriculum vitae for the principal Investigator. 
- 
Signed and dated Investigator agreement 
- 
Assurance that the reviewing IRB complies with the requirements set forth in Title 21 Part 56 of the CFR.  The 
required documentation will consist of the name and address of the IRB and a list of its members, including 
their titles, occupations, and any institutional affiliations, or a DHHS Assurance number. 
- 
A copy of the formal written notification regarding approval of the protocol by the IRB. 
- 
A copy of the IRB approved informed consent form and other adjunctive materials (e.g., advertising) used in 
the study, including written documentation of IRB approval of these items. 
- 
In addition to the documents required prior to the study, other documentation may be required during the 
course of the study. 
 
14.3.1 Source Documents 
Individual subject records will be maintained in the Investigator’s Source Documents (SDs).  Source documentation is 
generally considered to be the document on which the information or data point was first recorded.  SDs may include a 
subject's medical records, hospital charts, clinic charts, and the Investigator's study files as well as the results of 
diagnostic tests such as X-rays, laboratory tests, and electrocardiograms. The Investigator's copy of the CRF may also 
serve as part of the Investigator's source record for a subject's study-related data.  The following information should be 
entered into the subject's medical record: 


 
 
13 
October 21, 2015 
a. 
Subject’s name 
b. 
Subject’s contact information 
c. 
The date that the subject entered the study and the subject number assigned 
d. 
The study title and/or the protocol number of the study and the Sponsor’s name (Yardley Dermatology Associates, 
PC) 
e. 
A statement of the informed consent process and the date that informed consent and HIPAA authorization were 
obtained. 
f. 
Records of previous and current dermatological treatments and/or therapies 
g. 
Dates of all subject visits 
h. 
The date the subject exited the study, and a notation as to whether the subject completed the study or reason for 
discontinuation 
 
Study-specific information, such as Investigator and subject effectiveness and safety assessments may be recorded 
directly on the CRF.  With no prior written or electronic record, these data are considered to be source data and will be 
maintained in the Investigator’s study files.  Pertinent records related to the study, e.g., the subject’s medical chart, will be 
made available to the Sponsor representative on request with due precaution to protect the privacy of the subject.  
Personal identifying information (except subject initials) will be redacted on any photocopies of relevant medical records 
and replaced with the unique Subject Number before submission to the Sponsor.  The Investigator will protect the 
confidentiality of all subjects’ records within applicable federal, state and local laws.   
 
14.3.2 Case Report Form (CRF) Completion 
The Investigator is responsible for ensuring that data are properly recorded on each subject's CRFs and related 
documents.  The Investigators must sign the protocol signature page and will personally sign where indicated on the 
respective CRF pages to certify that the observations and findings are recorded on the CRFs correctly and completely. All 
required data will be recorded on the CRFs for this study, which will be designed and provided by the Sponsor. 
 
All CRF entries must be in ink; black is preferred.  An error will be corrected by a single line drawn through it, and the 
correct data, recorder’s initials and correction date will be entered adjacent to the error.  All errors must remain legible.  
Erasure or obliteration of errors on the CRF or other permanent study record is strictly prohibited.  
 
The reason for any missing CRF data will be explained: 
a. Not performed or not done = ND 
b. Cannot be determined or approximated, unknown = UNK or UN  
c. Does not apply, not applicable = NA 
d. No data are available = NAV 
 
Copies of the CRF pages will be collected by the Sponsor after review and verification of the completion and accuracy of 
the study data.  As needed, the Investigator will be contacted to clarify illegible or incomplete CRF entries.   
 
 
14.3.3 Retention of Documentation 
Essential documents are any records that demonstrate the compliance of the subject, Investigator, Sponsor, and Monitor 
with the study protocol, with standards of Good Clinical Practice (GCP), and with all applicable regulatory requirements.  
Essential documents (including but not limited to study-related correspondence, subject records, subject privacy 
documentation, records of the distribution and use of all investigational devices, and copies of CRFs should be retained 
and available for audit by the Sponsor’s auditor and regulatory authorities until at least 2 years after completion or 
termination of the study.  It is the responsibility of the Sponsor to inform the Investigator when these documents no longer 
need to be retained 
 
14.4 
Proprietary Information 
The information generated during this study is considered to be the property of the Sponsor, and cannot be used in 
publication without the written consent of the Sponsor. 


 
 
14 
October 21, 2015 
14.5 
Publications 
Sponsor-Investigator retains the right to publish study findings in the venue of its choice. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
15 
October 21, 2015 
14.6 
References 
 
1. Werschler, WP.  “Treating the Aging Face:  A Multidisciplinary Approach With Calcium Hydroxyl apatite and Other 
Fillers, Part 1”. Cosmetic Dermatology, November 2007; Vol 20(11): 739-742 
2. Werschler, WP; Smith, Scott, DO.  “Mechanism of Action of Poly-L-Lactic Acid: A Stimulatory Dermal Filler”.  
Supplement to Journal of Drugs in Dermatology, January 2007: Vol 6(1):18-20 
3.Beer, K. Popular Treatments for 2010. Skin and Aging, March 2011; Vol 19(3):23-24. 
4. Sapijaszko MJA. Dermal Fillers: Ever-Expanding Options For Esthetic Use. Skin Therapy Letter 2007;12(8):4-7 
5. LaTrenta GS. The aging face. In: Atlas of Aesthetic Face and Neck 
Surgery. Philadelphia, Pa: Saunders; 2004:46-66. 
6. Alam M, Yoo SS. Technique for calcium hydroxyl apatite injection for correction of nasolabial fold depressions. J Am 
Acad Dermatol 2007; 56: 285-9. (s) 
7. Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM. Update on Facial Aging. 
Aesthetic Surgery, July/August 2010 30: 11S-24S. 
8. Fried RG, Werschler WP. The Botulinum Toxin Experience: Results of a Patient Self-Report Questionnaire. J of Clinical 
and Aesthetic Dermatology 2009; Vol. 2, No. 11, 37-40. 
9. Fried RG. Remember me?  Helping patients come face to face with aging.   Skin and Aging 2009; Vol. 17, Issue 10, 42-
44. 
10. Fried RG. Filler cheeks: A bright idea? The “Eyes” have it.  Journal of Cosmetic and Aesthetic Dermatology 2011, Vol. 
4., No.5, 17-20 
11. Fried  RG.  Optimal Facial Rejuvenation: Looking for Help From Above. The Dermatologist 2014 Vol.22(12);18-19. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
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October 21, 2015 
APPENDIX 1:  Facial Volume Restoration Outcome Questionnaire 
Site # ______________  Subject # ______________ 
Treatment visit 1 date: _______________________ 
Treatment visit 2 date: _______________________ 
Treatment visit 3 date: _______________________ 
 
Date:  ________________________      
Sex:     ___ Female           ___ Male 
Age:  ___ 35-45     ___ 45-60    ___ 60-75 
City/Country of residence: ________________________ 
Number of Poly-L-Lactic Acid treatments: ____________
Please circle the number that best describes how you feel.  Circling the number one suggests that you believe 
that the description on the left hand column best describes how you feel. Circling the number 7 suggests that 
you believe that the description on the right hand column best describes how you feel.  Circling number 4 
suggests that you feel that there has been no change. Please be honest. 
 
Since my Poly-L-Lactic Acid injection (s),  I find that I am in general… 
 
1.  Less anxious     
 
 
 
1   2   3   4   5   6   7        
More anxious       
2.  More optimistic     
 
 
 
1   2   3   4   5   6   7       
Less Optimistic       
3.  More energetic     
 
 
 
1   2   3   4   5   6   7       
Less energetic       
4.  Eating more healthy food       
 
1   2   3   4   5   6   7        
Eating less healthy food       
5.  Happier    
 
 
 
 
1   2   3   4   5   6   7        
Sadder       
6.  Exercising more     
 
 
 
1   2   3   4   5   6   7        
Exercising less       
7.  Less irritable     
 
 
 
1   2   3   4   5   6   7        
More irritable       
8.  More amorous     
 
 
 
1   2   3   4   5   6   7         
Less amorous       
9.  More social     
 
 
 
1   2   3   4   5   6   7        
Less social       
10.  More productive      
 
 
1   2   3   4   5   6   7        
Less productive   
11.  More focused      
 
 
 
1   2   3   4   5   6   7        
Less focused       
12.  Less tired      
 
 
 
1   2   3   4   5   6   7        
More tired       
13.  Less angry      
 
 
 
1   2   3   4   5   6   7        
More angry       
14.  More confident        
 
 
1   2   3   4   5   6   7        
Less confident       
15.  More sexually confident       
 
1   2   3   4   5   6   7        
Less sexually confident       
16.  More assertive        
 
 
1   2   3   4   5   6   7        
Less assertive       
17.  Less argumentative       
 
 
1   2   3   4   5   6   7        
More argumentative       
18.  More comfortable with others      
 
1   2   3   4   5   6   7       
Less comfortable with others       
19.  More likely to go out     
 
 
1   2   3   4   5   6   7         
Less likely to go out       
20. More involved in community activities    
1   2   3   4   5   6   7      
 Less involved in community activities 
21.  Doing better at work/school     
 
1   2   3   4   5   6   7        
Doing worse at work/school       
22.  More in control       
 
 
1   2   3   4   5   6   7        
Less in control       
23.  Taking more medications       
 
1   2   3   4   5   6   7        
Taking less medications       
24.  Less depressed      
 
 
1   2   3   4   5   6   7         
More depressed       
25. Seen by others as less stressed    
 
1   2   3   4   5   6   7     
Seen by others as more stressed     
26. Feeling more attractive     
 
 
1   2   3   4   5   6   7         
Feeling less attractive       


 
 
2 
October 21, 2015 
27.  More relaxed       
 
 
 
1   2   3   4   5   6   7        
Less relaxed       
28.  Happier when looking in mirror    
 
1   2   3   4   5   6   7     
Less happy looking in mirror       
29.  Using less cosmetics to hide defects   
1   2   3   4   5   6   7     
Using more cosmetic to hide defects     
30.  Happier when my face is touched     
1   2   3   4   5   6   7     
 Less happy when my face is touched    
31.  My life is better        
 
 
1   2   3   4   5   6   7        
My life is worse      
32. Drinking more alcohol       
 
 
1   2   3   4   5   6   7        
Drinking less alcohol      
33.  Happier with my body     
 
 
1   2   3   4   5   6   7         
Less happy with my body     
34.  More in control of my eating     
 
1   2   3   4   5   6   7         
Less in control of my eating 
35.  More content     
 
 
 
1   2   3   4   5   6   7        
Less content          
Thank you for your time and honesty. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
3 
October 21, 2015 
APPENDIX 2: Investigator Global Assessment (IGA) of Facial Volume Loss 
 
Grade 
Description  
0 
No visible volume loss 
1 
Mild volume loss. 
2  
Moderate volume loss 
3  
Severe volume loss 
4 
Very severe volume loss 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
4 
October 21, 2015 
 
APPENDIX 3: Rosenberg Self-Esteem Scale 
 
 
Rosenberg Self-Esteem Scale 
Circle one response for each of the following ten items. 
 
Strongly 
Agree 
Agree 
Disagree 
Strongly 
Disagree 
1. I feel that I am a person of worth, 
at least on an equal basis with 
others. 
1 
2 
3 
4 
2. I feel that I have a number of good 
qualities. 
1 
2 
3 
4 
3. All in all, I am inclined to feel that I 
am a failure. 
1 
2 
3 
4 
4. I am able to do things as well as 
most other people.  
1 
2 
3 
4 
5. I feel I do not have much to be 
proud of.  
1 
2 
3 
4 
6. I take a positive attitude toward 
myself.  
1 
2 
3 
4 
7. On the whole, I am satisfied with 
myself. 
1 
2 
3 
4 
8. I wish I could have more respect 
for myself. 
1 
2 
3 
4 
9. I certainly feel useless at times.  
1 
2 
3 
4 
10. At times, I think I am no good at all.  
1 
2 
3 
4 
Source: Morris Rosenberg’s “Self-Esteem Scale” from pp-325-327 of Society and Adolescent Self-Identity 1989 by Morris 
Rosenberg, Wesleyan University Press.