Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Phase: EARLY_PHASE1
Conditions: Wrinkle, Photoaging
Sponsor: University of California, Davis

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
Page 1 of 11 
 
Revised:  January 31, 2017 
Protocol Title: Comparison of the cosmetic effects of bakuchiol 
and retinol 
Protocol Version Date: 31 August 2017  
1) Objectives 
We are looking to compare Bakuchiol and Retinol in 
reducing the appearance of photodamage. 
 
2) 
Background 
 
Retinoids are widely used in the treatment of wrinkles; however, the 
use of retinoids is associated with side effects such as skin dryness, 
redness, and peeling.  
 
Bakuchiol is a purified meroterpene of natural origin from the leaves of 
Psoralea Corylifolia. This compound acts as a retinoid analog. Clinical 
studies have shown significant improvement in the appearance of 
wrinkles, as well as skin firmness and photo-damage in patients using 
Bakuchiol without the side effects associated with the use of 
Retinoids(1).  
 
The aim of this study is to compare the cosmetic effects of Bakuchiol to 
Retinol over a 12-week period.  
 
3) Inclusion and Exclusion Criteria 
Inclusion criteria: 
 Individuals aged 30-55 
Exclusion Criteria: 
 Adults unable to consent 
 Individuals who are not yet adults (infants, children, 
teenagers) 
 Pregnant or breast feeding women 
 Prisoners 
 Those with visible signs in the area of application of or 
on active treatment for acne, eczema, seborrheic 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Revised:  January 31, 2017 
dermatitis, papulopustular rosacea or polycystic ovarian 
syndrome. 
 Those who have used isotretinoin in the last 6 months  
 Those who have used products containing salicylic acid, 
beta hydroxyl acids or vitamins A, C, or E in the last 14 
days  
 Those who have used topical antibiotics or topical 
retinoids in the last 30 days 
 Those who are currently smoking or have smoked within 
the past 3 years.  
 Those who have had a recent surgical or cosmetic 
procedure in the last 3 months that can affect facial 
wrinkles or facial hyperpigmentation, such as botulinum 
toxin injections, chemical peels, laser based therapies to 
the face, or face lift surgeries 
4) Study Timelines 
The duration of each subject’s participation is as follows: 
 
 Healthy volunteers –12 weeks 
 
This study will be conducted over the course of one year.  
 
5) Study Endpoints 
Primary study endpoints include: 
 Change in appearance of skin pigmentation 
 Change in wrinkle appearance 
 
         Secondary study endpoints: 
 Change in photographically measured skin texture and 
roughness 
 
 
 
 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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6) Procedures Involved 
 
Subjects meeting the inclusion criteria without any of the exclusion 
criteria will be enrolled into this study.  
 
Subjects will be randomized (double blind) to two groups: 
 
 Retinol Group (n= 25)  
 Bakuchiol group (n=25) 
         
The following procedures will be conducted:  
 
Procedures related to research: 
Bakuchiol 
Bakuchiol 0.5% applied to face twice daily  
 
Retinol 
0.5% retinol applied to face nightly 
 
Facial Photography: 
This will be conducted using digital visible light photography with 
no UV exposure of the face and neck. These photographs will be 
taken at all visits. After completion of all study visits, a 
dermatologist blinded to study group assignment will grade 
pigmentation, redness or wrinkles.  
 
Assessments: 
There will be a tolerability assessment of the skin performed by 
study staff to assess for subject based grading of facial redness,  
stinging, scaling, itching, and burning, as well as assessments by a 
board-certified dermatologist regarding facial erythema, scaling, 
hyperpigmentation, and hypopigmentation.  
 
Schedule of visits: 
 
Prescreening: 
1. Informed consent 
2. Review concomitant medication, topical agents and 
medical history  

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Revised:  January 31, 2017 
 
Visit 1: 
1. Pregnancy test for all female subjects, excluding females with 
hysterectomy. 
2. Facial photographs 
3. Randomization to either Bakuchiol or Retinol 
4. Study agent log given to each subject for the next 4 weeks  
5. Study agent will be weighed prior to being given to subjects 
6. Assessment: tolerability assessments 
7. In person application 
        
(Pre-screening and Visit 1 may take place on the same day) 
 
      
Visit 2 (week 4):  
1. Pregnancy test for all female subjects, excluding females with 
hysterectomy. 
2. Facial Photographs 
3. Previous diary card collected 
4. New diary card issued 
5. Study agent weighed  
6. Assessment: Tolerability assessments   
 
Visit 3 (week 8):  
1. Pregnancy test for all female subjects, excluding females with 
hysterectomy. 
2. Facial Photographs 
3. Previous diary card collected 
4. New diary card issued 
5. Study agent weighed  
6. Assessment: Tolerability assessments  
 
Visit 4 (week 12):  
1. Facial Photographs 
2. Previous diary card collected 
3. Study agent weighed and collected 
4. Assessment: Tolerability assessment 
 
 
 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Revised:  January 31, 2017 
 
 
 
 
Subject compensation is outlined as follows: 
 
 $100 for completion of the whole study.  If the subject leaves the 
study early, this amount will be pro-rata:  
Visit 1: $20 
Visit 2: $20 
Visit 3: $30 
Visit 4: $30 
 
 
Protocol Activity 
Screening 
 
 
 
Pre-Screen 
      
Visit 1  
(Day 0) 
Visit 2 
(4 
weeks 
+/-1 
week) 
Visit 3 
(8 weeks 
+/- 1 
week)  
Visit 4 
(12 
weeks 
+/- 1 
week)  
 
Informed Consent 
X 
 
 
 
 
 
Medical and Surgical 
History 
X 
 
 
 
 
 
Review concomitant 
Medication 
X 
 
 
 
 
 
Pregnancy test 
 
 
 
X 
X 
 
 
X 
 
 
Facial photography 
 
X 
X 
 
X 
 
X 
 
Tolerability 
assessments  
 
X 
X 
 
X 
 
X 
 
Study agent 
dispensed 
 
X 
X 
 
X 
    
 
 
Application of study 
agent 
 
X 
 
 
 
 
Sunscreen dispensed 
 
X 
 
X 
 
 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Study agent returned 
 
 
X 
 
X 
 
 
X 
 
Weighing of study 
agent and sunscreen 
 
X 
X 
 
X 
 
X 
 
 
 
 
7) Data and/or Specimen Management and Confidentiality 
All data will be coded for the safety of the study subjects. Research data 
will only be available to the listed research personnel. The research site 
will maintain appropriate medical and research records for this study in 
compliance with ICH E6, Section 4.9 and regulatory and institutional 
requirements for the protection of confidentiality of subjects.  
 
All of the study data will be coded and stored within a locked cabinet 
within a locked room with two levels of keyed entry required to gain 
access. Furthermore, data files will either be stored in password-
protected files within a locked room that will require two levels of 
keyed entry for access.  
 
Precaution will be taken to maintain the privacy of the participants. 
These include the following: All subjects will be assigned a subject ID 
number after signing the consent form. This will be their only form of 
identification throughout the remaining of the study period. Each 
subject’s name, age, medical record number, and group assignment will 
be recorded. The consent forms will be kept in a binder. The subjects 
will be entered into the data analysis sheets as subject ID numbers and 
a separate password-protected file will contain the key for these codes. 
All of the files will be saved on password-protected computers within 
locked rooms. All study related material will be kept in a locked cabinet 
within a locked room at UC Davis Department of Dermatology. Only the 
research team personnel will have access to study- related materials. 
Participant information will not be disclosed to third party individuals 
except for those authorized to oversee the research project. 
 
Samples that are already collected will not be destroyed but will be 
stored in a codified format that will not allow linkage to identifying 
information. If the subject withdraws from the study, we will destroy 
their entry in the code key. We will make subjects aware that any 

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collected material/samples will not be destroyed during the consent 
process but that their identifying code entry in the code key will be 
deleted if they withdraw from the study.  
 
The facial photographs are immediately stored after capture into a 
password-protected computer that will be stored in a locked room within 
the UC Davis Clinical Trials unit. These photographs will not have any 
associated names or other identifiers with them and will be stored with 
coded file names.  
 
Each of the subjects’ signed consents will be filed in a locked cabinet 
within a locked room. All of the subjects’ data will be entered into the 
data analysis sheets as codes and a separate password protected file 
will contain the key for these codes. All of the files will be saved on 
computers that will be within locked rooms. The research team will 
follow the UC Davis Institutional Policy for data security to ensure that 
all subjects and collected data are protected. The coded images will not 
have any link to identifying information except through the subject code 
that will be stored in a password protected document that will be stored 
on password protected computers within a locked room. At the end of 
the study, the code key files will be deleted such that there will be no 
way for the study team to link the codes with any identifiable 
information. 
 
We will also utilize StudyPages for recruitment. StudyPages is a 
secure cloud-based clinical research recruitment solution. Study 
coordinators can set up a dedicated webpage for a research study, 
share over email and social media with target communities, and 
collect contact information from potential participants. 
 
StudyPages listings are intended to be consumer-facing, with an 
emphasis on the use of plain language combined with educational 
materials and a clear call to action for interested visitors. The goal is 
to provide a simple way for people to discover and participate in 
research. 
 

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StudyPages is an additional tool for researchers to maximize the 
success of a human subject study; reaching a more diversified 
audience, compressing recruitment timelines, and reducing costs. 
 
Privacy and Security 
Yuzu Labs does not sell data to third parties. User data collected is 
only provided to the study coordinator and optionally to Yuzu Labs, if 
a user chooses to be notified of future research. The full policy is 
located here: http://studypages.yuzulabs.com/privacy_terms 
 
StudyPages meets applicable 21 CFR Part 11 requirements. The 
StudyPages platform consists of a network of cloud servers and any 
data transfer in/out of the system is encrypted using SSL. It is hosted 
on Amazon Web Services (AWS) using Heroku. Both AWS and Heroku 
have implemented robust security tracking and monitoring 
procedures to ensure secure transactions and data protection in the 
cloud. Additional information about the security and compliance of 
our hosting infrastructure can be found at 
http://aws.amazon.com/security, 
http://aws.amazon.com/compliance, and 
http://policy.heroku.com/security 
 
All StudyPages data is stored in the Application Database and Yuzu 
Labs maintains daily backups to ensure data integrity and provide 
disaster recovery protection. 
 
 
8) Data and/or Specimen Banking 
 
All patient information will be only accessible to authorized research 
personnel only, and otherwise personalized information will be locked 
in a cabinet and password protected electronic drive at the UC Davis 
Department of Dermatology during the trial. After the study has 
completed and analyzed, all patient information will be discarded. The 
code keys will be stored in a secure file in a password-protected 

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computer in a locked room and this code key will be deleted upon 
completion of the analysis.  
 
 
9) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The records and study materials will be maintained in a locked 
cabinet. Subjects will be asked about their health and any adverse 
events that may have occurred. Adverse effects will be related to 
the treating physician if it is deemed to be study agent related. All 
subjects will receive a number to contact if they note any side 
effects. Noted and serious adverse effects will be relayed to the 
IRB within 24 hours of the occurrence.   
 
10) Withdrawal of Subjects 
 
The subjects may withdraw consent at any time and they will be 
reassured that their clinical care will not be compromised if a 
subject were to withdraw. Subjects will be withdrawn from the 
study if they develop adverse side effects. The investigator can 
remove the subject from the study. Possible reasons for removal 
include: 
 Noncompliance with the protocol 
 Significant protocol deviation 
 
11) Risks to subjects 
The two randomized treatments have certain risks. Subjects will be 
counseled that the physical risks from retinoid based topical agent (if 
they are randomized into this group) may include skin redness, dryness, 
peeling, or irritation. The physical risks from bakuchiol topical (if 
subject is randomized into this group) may include mild itching or 
redness with sensitive skin. Subjects will be advised to inform the 
research team if they experience any side effects.  
Additionally, some subjects may feel uncomfortable during the 
photographic process.  Although provisions are put in place to protect 
identifiable data, we cannot guarantee absolute protection of the data 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Revised:  January 31, 2017 
and photographs collected from each subject. Accordingly, the subjects 
will be informed of this risk.  
 
12) Potential Benefits to Subjects 
There are no direct benefits to the subjects. Subjects may see 
improvements in wrinkles and/or photo-damage. 
This study will help us add to the general scientific knowledge 
that may benefit individuals in the future.   
  
13) Sharing of Results with Subjects 
Any peer reviewed manuscripts that result from the study will be 
made available to the subjects on request.  
 
14) Provisions to Protect the Privacy Interests of Subjects 
 
Steps will be taken to protect subjects’ privacy interests. Subjects will 
only interact with approved study personnel who have successfully 
completed human subjects training. This includes those involved in the 
study visits, consent, and in any study related procedures. We will do 
our best to make sure that the personal information in the subject’s 
medical record is kept private. However, no study can guarantee 100% 
protection of private information despite all of our measures to protect 
each subject’s privacy. Subjects will be made aware of this during the 
consent process.  
 
 
15) Compensation for Research-Related Injury 
 
If a subject is injured as a result of being in this study, the University of 
California will provide necessary medical treatment. Depending on the 
circumstances, the costs of the treatment may be covered by University 
or the study sponsor or may be billed to the subjects’ insurance 
company just like any other medical costs. The University and the study 
sponsor do not normally provide any other form of compensation for 
injury. For more information about compensation, call the IRB 

PROTOCOL TITLE: Comparison of the cosmetic effects of bakuchiol and retinol 
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Revised:  January 31, 2017 
administration at (916) 703-9151 or email at 
IRBAdmin@ucdmc.ucdavis.edu. 
. 
16) Economic Burden to Subjects 
 
Standard of care and other routine costs will be billed to the patient or 
the patient’s insurance carrier, Medicare, or Medi-Cal where 
appropriate. Only the costs of research and experimental procedures 
will be paid by the sponsor/department. Subjects may incur a cost in 
relation to travel needed to get to the UC Davis Dermatology 
Department for each visit.  
 
17) Drugs or Devices 
☒ I confirm that all investigational drugs will be received by the 
IDS pharmacy, which will store, handle, and administer those 
drugs so that they will be used only on subjects and be used 
only by authorized investigators.  
 
☒ I confirm that all investigational devices will be labelled in 
accordance with FDA regulations and stored and dispensed in 
such a manner that they will be used only on subjects and be 
used only by authorized investigators. 
 
There are no investigational drug or devices used in this topical 
cosmetic study.  
 
References: 
 
1. 
Chaudhuri RK, Bojanowski K. Bakuchiol: a retinol-like functional compound 
revealed by gene expression profiling and clinically proven to have anti-aging effects. Int 
J Cosmet Sci. 2014;36(3):221-30.