Effect of Combination Laser Treatment and Skin Brightening Topical on the Appearance of Skin Tone and Photoaging: A Pilot Study
Phase: NA
Conditions: Photoaging
Sponsor: University of Miami

IRB Study Number: 20171006 
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Title: Prospective Comparative Study of Non-ablative Laser with and 
without LyteraTM 2.0 Pigment Correcting Serum on the Appearance of 
Skin Tone and Photoaging 
 
 
NCT: NCT03661697 
Last IRB Modification and Approval: 3/25/2019 
 

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1) 
Protocol Title 
 
Effect of Combination Laser Treatment and Skin Brightening Topical on the 
Appearance of Skin tone and Photoaging: A Pilot Study 
 
2) 
Objectives*  
 
Our objective is to determine the effects of (1) basic skin care regimen + 
“active” (Lytera 2.0) vs (2) basic skin care regimen only, both groups 
combined with laser treatment on the appearance of skin tone and photo-
aging on the face 
 
 
Our hypothesis is that combination laser + brightening cream (active arm) 
will improve appearance of skin tone and photoaging of the face when 
compared to combination laser + non-brightening cream. 
 
3) 
Background*  
Photodamaged skin can be characterized by alterations to skin tone, fine 
wrinkles, and tactile roughness. These changes in skin appearance are 
usually due to chronic exposure to ultraviolet radiation. It is a common and 
often distressing skin condition that can also be difficult to treat. A wide 
variety of treatments are available to treat these alterations in skin such as 
cosmetic topicals, chemical peels, dermabrasion, cosmetic lasers, 
neuromodulators, and dermal fillers. Topicals are often the starting point for 
treatment of photodamage and can be used before, during, and after office 
procedures to augment outcomes for patients.  Laser treatment is indicated 
for correction of existing mild-severe photodamage/aging skin. After 
treatment, patients can expect to have more uniform skin tone, improved 
texture, more radiant skin, minimized pore size appearance, and skin that 
looks and feels clear and brilliant. Results can be immediate but are also 
progressive, improving over multiple treatments. Clinicians have now begun 
to investigate the usefulness of integrating skincare products and cosmetic 
lasers.  
The gold standard for improving the appearance of photoaging and 
hyperpigmentation (specifically solar lentigines) has been a hydroquinone-
containing product. Makino et al compared Lytera 2.0 (a Correcting Serum) 
to Hydroquinone 4% in a randomized, split-face double blind study in 
subjects with moderate to severe skin tone. Lytera 2.0 showed statistically 
significant results at 2 weeks and Hydroquinone 4% showed statistically 
significant results at 4 weeks. Lytera 2.0 is a cosmetic product that is for 
brightening the appearance of skin does not contain any hydroquinone or 
other ingredient classified as a drug. (Please see the Lytera 2.0 patient 
brochure in the attached documents).The 1927 nm fractional non-ablative 

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laser has also been found to be effective in treating the pigment in photo-
damaged skin.  
In our study, only patients with Fitzpatrick skin types I through IV will be 
recruited as those with a higher level than skin type IV can be prone to 
overproduction of melanin following certain laser types. Fitzpatrick skin type 
I is highly sensitive, always burns, and never tans. Type II is very sun 
sensitive, burns easily, and hardly tans. Type III is sensitive, sometimes 
burns, and tans to light brown. Type IV is minimally sun sensitive, burns 
minimally, and tans to moderate brown. Type V is insensitive skin, rarely 
burns, and tans well. Type VI is insensitive, never burns, and is deeply 
pigmented. 
Although laser treatment and lightening skin care products have been 
shown to improve skin tone and photo aging, currently, there is no clinical 
data to support the efficacy and longevity of combination laser treatment + 
brightening skin care products for photoaging and skin tone.  Our study will 
attempt to observe if combination non-ablative laser (1927 nm also known 
as Clear and Brilliant) and Lytera 2.0 Correcting Serum will improve the 
appearance of skin tone and photoaging when compared to laser alone.  
 
4) 
Inclusion and Exclusion Criteria*  
Inclusion criteria: 
Healthy adult male and female patients 18 years and older 
Fitzpatrick skin types I-IV 
Has at least mild mottled skin tone of the face (score of 2 or more on a 5 
point skin tone scale) 
Has at least 2 areas of the face with significant roughness, dyspigmentation, 
or fine lines or has all these characteristics in 1 or more areas 
Willing to refrain from using any other topical products on the face, systemic 
retinoids, or steroids, facial peels or other facial laser procedures throughout 
the duration of the study 
Willing to refrain from any cosmetic procedure including but not limited to 
facial surgery, dermal fillers, and neuromodulators for the duration of the 
study 
Willing to use only the facial skin care product regimen provided for the 
study 
Willing to avoid extended periods of sun exposure and the use of tanning 
beds during the study 
Willing to have photographs taken of the face to be used de-identified in 
evaluations, publications, and presentations 
For females: proof that they are not pregnant (urine pregnancy test) 
English-speaker 
 
 
Exclusion criteria: 
Has any uncontrolled systemic disease (such as autoimmune disorders and 

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connective tissue disorders such as lupus erythematosus or Sjogren’s 
syndrome 
Has any active infection in face 
Has history of any skin conditions that could interfere with treatment 
Has used self-tanner recently 
Is currently participating in another drug research study 
Is NOT willing to refrain from using any other topical products such as skin 
lightening, retinoids, alpha/beta-hydroxyl acids, salicylic acid, vitamins C or 
D, steroids, or antibiotics on the face or systemic retinoids, steroids, facial 
peels, neuromodulators, dermal fillers, facial surgery, or other facial laser 
procedures throughout the duration of the study  
For females: is pregnant 
Non English-speaker 
 
 
Individuals will be screened for eligibility via questionnaires that address 
each of the inclusion and exclusion criteria. Our final study sample will 
include the subjects who met the inclusion/exclusion criteria and did not 
voluntarily drop out of the study or develop adverse effects that prohibited 
them from safely completing the study. We will exclude adults unable to 
consent, patients under the age of 18, pregnant women, and prisoners. 
 
5) 
Number of Subjects* 
After recruiting our subjects, 14 patients will be randomized into either arm 
of the study (7 in each arm).  
 
6) 
Study-Wide Recruitment Methods* 
This is a single center study. We will recruit subjects from a clinical 
database of the practice of Dr. Lisa Grunebaum.  We will use several 
recruitment methods including invitation via a scripted email providing 
information describing the study protocol and end-points, scripted 
invitation telephone calls, and flyers.  
 
 
 

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7) 
Study Timelines* 
 
  
Screening/Baseline 
Visit 1  
Washout 
period 
Visit 2 First 
Laser 
treatment (4 
weeks +/- 5 
days after 
baseline 
visit) 
Visit 3 
Second 
Laser 
Treatment 
(3 weeks +/- 
5 days after 
first laser 
treatment) 
Visit 4 Last 
day of 
topical 
treatment (4 
weeks +/- 5 
days after 
second laser 
treatment)  
Procedures 
  
  
  
  
  
Informed Consent 
X  
  
 
 
 
Inclusion/Exclusion 
criteria 
X  
  
 
 
 
Demographic History 
Questionnaire 
X  
  
  
  
  
Medical History 
Review 
X  
  
  
  
  
Skincare History 
Review 
X  
  
  
  
  
Evaluate Fitzpatrick 
skin type 
X 
  
  
  
  
Evaluate baseline 
hyperpigmentation 
X 
  
  
  
  
Urine dipstick test 
X  
  
X 
X 
X 
Self assessment 
questionnaire 
X 
  
  
  
X 
Standardized Digital 
photography 
X 
  
X 
X 
X 
Adverse effects 
review 
X 
  
X 
X 
X 
MoPASI evaluation 
X 
  
X 
X 
X 
GAIS evaluation 
X 
  
X 
X 
X 
Anesthetizing topical 
application 
 
  
X 
X 
X 
Protective goggles 
placed 
  
  
X 
X 
 
Laser treatment 
performed 
 
  
X 
X 
 
Exit Questionnaire 
 
 
 
 
X 
 
 
Potential participants will receive a thorough history and dermatologic 
physical exam to determine if patients meet the inclusion/exclusion criteria 
for being in the study. Urine dipstick tests will be performed on female 

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patients to confirm they are not pregnant. Consent will be obtained from 
eligible participants and will be enrolled in the study. 
 
The study will be conducted over a 12 week period. There will be a 4 week 
washout period prior to laser treatments when the subjects will begin two 
skin care regimens, which are described below. Then there will be 2 laser 
treatments separated by 3 weeks. The subjects will continue the topical 
treatment 1 month after the 2nd laser treatment.  
 
There will be 4 study visits: Baseline Visit 1, First laser treatment Visit 2 (4 
weeks +/- 5 days after baseline visit), Second laser treatment Visit 3 (3 
weeks +/- 5 days after first laser treatment), and Last day of topical 
treatment Visit 4 (4 weeks +/- 5 days after second laser treatment). During 
these visits, photographs of the participants’ faces will be taken. Patient 
questionnaires will be given at baseline and at the end of the study. 
 
Investigators will complete the study 4 months after subjects have 
completed their participation in the study.  
 
8) 
Study Endpoints* 
The study will reach endpoint for each patient either 1) once they 
have completed their exit survey after the 2 laser treatments and the 
topical treatments or 2) if they experience any adverse reactions from 
treatment and must be pulled from the study.  
 
9) 
Procedures Involved* 
One month prior to laser treatments (washout period), 14 male and female 
subjects with moderate hyper pigmentation and photo damage of the face 
will be randomized to 2 skincare regimens.  
 
The regimens are: 
- “Placebo arm” – Basic skin care regimen* (Facial Cleanser, TNS ceramide 
Treatment Cream (standard post-procedure moisturizer), and Essential 
Defense Mineral Shield Broad Spectrum SPF35 (all-physical sunscreen) 
- “Lytera arm” – Basic skin care regimen + Lytera 2.0, which will be added 
between the Facial Cleanser and TNS Ceramide Treatment Cream 
 
*The basic skin care regimen is a standard regimen used in several 
skincare product experiments 
 
After cleansing the face, the patients in the Lytera arm will apply one pump 
of the pigment-correcting serum in a circular motion to the entire face 

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including the forehead, cheeks, chin, nose, and neck with care to avoid the 
eyes. The Lytera 2.0 is applied prior to applying moisturizer and sunscreen. 
 
On laser treatment days, patients will come into the office without having applied 
any topical cream that day. Lidocaine topical may or may not be applied over the 
face avoiding the eyes (lidocaine use will be at discretion of Principal 
Investigator), and patients will be given protective goggles to shield the eyes 
during laser treatment. Next, the laser wand is pressed to the face and passed 
over the skin in various horizontal and vertical directions. Treatment takes 20 to 
30 minutes.  
 
Standardized digital photographs will be taken at baseline and at each 
subsequent visit using the Canfield VISIA Complexion Analysis (VISIA-CA) 
camera system at the highest resolution in a consistent position.  Pictures 
will be taken before laser treatments on Visit 2 and Visit 3. 
 
The subjects will complete an exit questionnaire after completion of the 
study at their last study visit (Visit 4).  Through the questionnaire, we 
will obtain information on subject satisfaction with the study as well as their 
opinion of how their skin has changed. We hope to use the responses 
to assess efficacy of our skincare regimen and to improve future related 
research protocols. 
 
Local tolerability including itching, redness, burning, or pain will be assessed 
at each visit by the investigator. Subjects will also be asked to assess 
discomfort during treatment and also to maintain diary at home to record 
any side effects after each facial laser treatment. To lessen the probability of 
risks of laser treatment, will use the standard pulse energy and coverage 
known to produce the minimal amount of side effects, increase subject 
comfort, and allow for rapid healing.  
 
Once all subjects have completed the study, one independent evaluator will 
retrospectively analyze the VISIA high definition photography data that was 
taken at each visit. The independent observer will evaluate the photos of 
each patient for clinical efficacy and tolerability using two validated grading 
scales (Modified Pigmentation Area and Severity Index (MoPASI) and 
Global Aesthetic Improvement Scale (GAIS)) at baseline and at weeks 5, 8, 
and 12. 
 
The GAIS is used to evaluate change in aesthetics after intervention. 0 = 
worse, 1 = no change, 2 = improved, 3 = much improved, 4 = very much 
improved. The MoPASI is a dermatologist-developed modified scale derived 
from the validated Melasma area and severity index scale. Pigmentation is 
assessed in 4 sections of the facial skin, and three variables are assessed 
within each region: percentage of area involved, darkness of pigment in the 
area, and pattern of involvement in the area. Subjects will complete self-

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assessment questionnaires at baseline and at the end of the study. 
 
The Clear and Brilliant 1927nm laser has been used extensively in facial 
cosmetic surgery for skin resurfacing to improve the skin changes 
associated with photoaging and skin tone. The laser is FDA approved for 
this use (see Device attachments for documentation). The Solta Medical 
Company has proven that it produces safe and effective treatment and even 
in combination with topicals, has a high safety profile (see supporting 
documents).  
 
 
Lytera 2.0 Correcting Serum, a Skin Medica product, is a non-hydroquinone, 
non-drug advanced Correcting Serum that has been proven to minimize the 
appearance of skin discoloration and dark spots.  Our proposed study is to 
observe the effect of Lytera 2.0 on skin tone, and will not evaluate any 
underlying changes to skin structure or function.   The assessments in the 
proposed study are observational and do not include biopsy or other 
method.  
 
Key ingredients of Lytera 2.0 Pigment Correcting Serum: 
Tranexamic Acid  
Phenylethyl Resorcinol  
Niacinamide and Tetrapeptide 30  
Marinen Extract blend  
Phytic Acid  
Other ingredients: Vitis Vinifera SCE, Plankton Extracts, 
Hydroxyacetaphenone, Artemisia Capillaris, Marine Exopolysaccharides 
 
Data that will be collected about subjects (see attached data collection 
form): 
Age 
Gender 
Race 
Past medical history including current and past illnesses, current 
medications, allergies, past surgeries, any past adverse effects to facial 
cosmetics, family history, social history including alcohol, tobacco, or illicit 
drug use.  
Past skin care history including any surgical cosmetic procedures, fillers, 
injectables, lasers, or topical treatments.  
Fitzpatrick skin type (I-IV) 
Evaluation of baseline skin tone 
Adverse effects experienced throughout the study 
MoPASI scores 

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GAIS scores 
Representative photographs of subjects at baseline and at subsequent visits 
 
 
 
10) Data and Specimen Banking*  
Data will be stored on Box, a secure file sharing, storage, and collaboration 
system using a password-protected, encrypted laptop. Data will be stored 
for 1 year after the completion of the study. Only Dr. Lisa Grunebaum, 
principal investigator and Dr. Ope Fawole and Caitlin Coviello, co-
investigators and study coordinator will have access to the data. Data will 
only be released by Drs. Grunebaum or Fawole for publication of study 
results.  
 
Stored data will include: 
Age 
Gender 
Race 
Past medical history including current and past illnesses, current 
medications, allergies, past surgeries, any past adverse effects to facial 
cosmetics, family history, social history including alcohol, tobacco, or illicit 
drug use.  
Past skin care history including any surgical cosmetic procedures, fillers, 
injectables, lasers, or topical treatments.  
Fitzpatrick skin type (I-IV) 
Evaluation of baseline skin tone 
Adverse effects experienced throughout the study 
MoPASI scores 
GAIS scores 
Representative photographs of subjects at baseline and at subsequent visits 
 
11) Data Management* 
Statistical analysis will be conducted to determine the effect size necessary 
to power a study. All statistical tests will be two-sided and interpreted at a 
5% significance level. The primary analyses will be based on the MoPASI 
and GAIS scores. Scores after each laser treatment will be compared to 
baseline scores using the appropriate statistical test.  
 
Data will be secured and stored on Box, a secure file sharing, storage, and 
collaboration system using a password-protected, encrypted laptop.  
 
Information that will be included in data include demographic information, 
skin type, baseline hyper pigmentation, adverse effects, validated scale 
scores, photographs, past medical and skin care history as listed above.  
 
Data will be stored in Excel sheet on the encrypted system, Box, which will 

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give us access to the data via an encrypted stream of traffic. No actual copy 
of the data will be stored on a machine. Data will be stored for a short-term 
retention period of 5 years or less at the location 1150 NW 14th St Suite 150 
Miami, Fl 33136. The principal and co investigators will have access to the 
data. Drs. Grunebaum and Fawole will be responsible for transmission of 
data. Data will be transported via laptop.  Aforementioned laptop will be 
completely shut down after all browser data has been cleared before being 
transported or left unattended. In addition to the data encryption, a 
passcode into the device will be required.  
 
12) Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
The physician investigators and the subjects themselves will monitor the 
type, severity, duration, and frequency of adverse effects during treatment. 
Adverse effects will be evaluated by investigator at each visit. Subjects will 
fill out diary while at home to record any adverse effects. Investigator will be 
accessible to subjects via email and phone to answer questions about any 
adverse effects. Safety data and efficacy data (based off of validated scale 
scores) will be reviewed after each visit. Safety information will be collected 
at study visits and by email communication with participants. Safety data 
collection will begin on day 1 of the washout period when subjects begin the 
skin care regimen. The investigators will review the data at each visit and as 
needed. Safety information that will be collected includes pain, visual 
disturbance, rash, fever, infection, photosensitivity, scarring, and changes in 
skin color.  
 
If a patient becomes pregnant, develops severe post-inflammatory skin 
tone, or experiences an anaphylactic or other severe allergic reaction, they 
will be pulled from the study. If they exhibit any of the “exclusion criteria” 
after initial evaluation of eligibility for participation in study, they will also be 
removed from the study.  
 
13) Withdrawal of Subjects* 
If a patient becomes pregnant, develops severe post-inflammatory skin 
tone, excessive scarring, burning, or experiences an anaphylactic or other 

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severe allergic reaction or infection requiring antibiotic treatment, they will 
be pulled from the study.  
 
If they exhibit any of the “exclusion criteria” after initial evaluation of 
eligibility for participation in study, they will also be removed from the study.  
 
Exclusion criteria: 
Has any uncontrolled systemic disease (such as autoimmune disorders and 
connective tissue disorders such as lupus erythematosus or Sjogren’s 
syndrome 
Has any active infection in face 
Has history of any skin conditions that could interfere with treatment 
Has used self-tanner recently 
Is currently participating in another drug research study 
For females: is pregnant 
Non English-speaker 
 
Participants that develop criteria for withdrawal from the study or any 
potential side effect will be examined in the office.  Participants that meet 
criteria for withdrawal from treatment will be informed during office visit.  
Safety information will still be collected until week 12 of the study. 
 
 
 
14) Risks to Subjects* 
 
Side effects of Lytera topical include stinging or tingling on application, 
redness, and general irritation in those with sensitive skin.  
 
There are some expected side effects of the Clear and Brilliant facial laser 
procedure. These may include discomfort, redness, swelling, heat 
sensation, dark spots, flaking, itching, acne formation, herpes simplex 
reactivation, blistering, and dryness. Patients can expect facial redness 
immediately after treatment that commonly resolves within a few hours but 
may last until the next day in some patients. Possible risks or complications 
associated with this facial laser procedure include bleeding or crusting, 
burns, scarring, pigment changes, infection, and eye injury.  It has been 
shown that adverse effects typically resolve without discontinuation of the 
products. There may be psychological risks associated with treatments as 
patients may feel self-conscious about erythematous face for a couple days 

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after the laser treatments. If subjects experience any of the aforementioned 
side effects, this may also be distressing.  
 
Potential risks of combination Clear and Brilliant laser and Lytera treatment 
include all of the side effects listed above.  
 
Lytera 2.0 Pigment Correcting Serum does not contain any known 
teratogenic ingredients, however, the safety of the product has not been 
established in women who are pregnant, planning to be pregnant, or 
breastfeeding. While laser treatment is not recommended during pregnancy, 
it has not been shown to harbor any risks to the embryo. Patients will need 
to discuss risks vs benefits with their obstetricians. Subjects who become 
pregnant during study will not continue participation and will also be 
instructed to notify their obstetrician about their study participation.  
 
15) Potential Benefits to Subjects* 
Benefits to subjects are myriad, as combination topical and laser treatment 
is intended to moderately improve photo damaged and poor skin tone which 
can be distressing for patients. Facial cosmetic laser helps prevent and 
address early signs of aging skin, maintain younger-looking skin, and 
improve tone, texture and radiance. After even two treatments, patients can 
expect to have more uniform skin tone, improved texture, more radiant skin, 
minimized pore size appearance, and skin that looks and feels clear. The 
skin will continue to improve for several months following treatment.  
16) Vulnerable Populations* 
We will not be investigating any vulnerable populations. Once again, we will 
not include pregnant females in the study as skin changes that may be 
seen in pregnancy may influence the results of the study.  
17) Sharing of Results with Subjects* 
Results of study will be shared with subjects if they are interested in 
knowing results. This will be shared over the phone after the data has been 
analyzed.  
18) Setting 
Research will be conducted in the Facial Plastic and Reconstructive Surgery 
Department at the Professional Arts Center at the University of Miami 
Health System. 
19) Resources Available 
The principal investigator is a double board certified physician by 
the American Academy of Otolaryngology and the American 
Academy of Facial Plastic and Reconstructive Surgery. She has 
been in practice in Miami for over a decade and is thus very familiar 
with the population seeking skin care options for photo damage. 
One of her areas of expertise includes laser treatments for scars 
and facial rejuvenation. She already uses the laser specific to our 
study in her practice and is thus quite familiar with it. The 
secondary investigator is a third year Otolaryngology resident with 

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a 4 month dedicated research period in which she plans on 
recruiting subjects, performing treatments, taking standardized 
photos, and analyzing results with the Biostatistician.  
Our facilities include a dedicated Plastic surgery and reconstructive 
state-of-the-art treatment center with spacious, inviting rooms. 
There is a dedicated area for taking standardized photos. 
We will provide pamphlets on medical and psychological resources 
that subjects may need throughout duration of treatment 
We will have several meetings with all members of the team prior to 
the start of the study in order to make sure everyone is informed 
about the protocol and their duties. 
 
 
Recruiting 14 participants for this study is feasible as Dr. 
Grunebaum’s clinical database contains over 100 interested 
patients. 
 
20) Prior Approvals 
We are applying for an Allergan Research Grant for Investigator 
Initiated Trials.  
21) Recruitment Methods 
We will recruit subjects from a clinical database of the practice of Dr. 
Lisa Grunebaum.  We will contact these patients with invitation via 
several methods: a scripted email, a telephone script, and study 
flyers providing information describing the study protocol and end-
points.  
22) Local Number of Subjects 
We need 14 subjects. Seven patients will be randomized to one of 
two treatment arms. We expect to screen several patients and 
identify 14 participants that meet inclusion/exclusion criteria. 
23) Provisions to Protect the Privacy Interests of Subjects 
Subject’s demographic and safety and efficacy data will be stored 
in password-protected, encrypted laptop. Only the investigators and 
biostatisticians will have access to these files. Patients will be de-
identified and will be assigned a number that will go along with the 
data.  
Subjects will be reassured that this is a clinical trial and that they 
can be guaranteed the same confidentiality that they would be 
afforded in a Doctor’s office information. Only personal questions 
pertinent to patient’s history of skin care will be asked. Procedures 

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are noninvasive and there will be a second party (nurse or 
assistant) in the exam room during treatments as a witness.  
24) Compensation for Research-Related Injury 
Participants will not be compensated for this study or for research-
related injury.  Participants will be treated for their injuries, however, 
patient or insurance may incur costs related to injury.  
 
25) Economic Burden to Subjects 
Topical facial treatments and laser treatments will be provided to 
the subjects at no cost. Participants will not be compensated for 
this study or for research-related injury.  Participants will be treated 
for their injuries, however, patient or insurance may incur costs 
related to injury.  
 
 
26) Consent Process 
After the potential subject receives information/invitational email 
about the study and endorses interest in participation, the potential 
subject will be contacted via telephone to schedule a face-to-face 
interview, history, and physical exam, and to answer any 
outstanding questions and counsel on what to expect. If potential 
subject agrees to participate after conversation and meets 
inclusion/exclusion criteria, we will obtain informed consent. During 
each visit, subject will confirm ongoing consent to participate in 
study. We will follow the “SOP: Informed Consent Process for 
Research (HRP-090).” Our study will NOT include Non-English 
speaking subjects, minors, cognitively-impaired adults, pregnant 
women, prisoners, or adults unable to consent. Our rationale for 
excluding non-English speakers is that the department has no 
provision for readily available interpreters; thus, it would not be 
possible to obtain a valid consent due to the inability to fully 
understand the research and the risks and benefits of participation 
making this non-English speaking population vulnerable. Given that 
the study does not target serious or life threatening conditions, the 
investigators did not find it imperative to include eligible, non-
English speaking subjects.  
27) Non-English Speaking Subjects 
Not applicable 
 

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28) Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
A chart review from the Investigator clinical database will be 
required to identify prospective subjects who will then be contacted 
and asked to participate in the study. Investigators request a partial 
HIPAA waiver to review the charts to identify subjects. Only the 
minimum information will be collected in order to make contact with 
the subject. Informed consent/HIPAA authorization will be obtained 
from the subjects prior to any additional data collection.  
29) Subjects who are not yet adults (infants, children, teenagers) 
Not Applicable 
30) Cognitively Impaired Adults 
Adults who do not meet minimum criteria on the MME will be 
excluded.  
31) Adults Unable to Consent 
Not. Applicable 
32) Adults Unable to Consent 
Not applicable. 
33) Process to Document Consent in Writing 
Our study will have a written consent documenting the goals of the 
study, possible risks and benefits. Consent will be documented on 
standard informed consent form. (HRP-091 – see attached). 
34)  Drugs or Devices 
The Clear and Brilliant 1927 nm laser handpiece will be kept in 
the Plastic Surgery clinic and only handled during laser 
treatments. The topical creams will be applied by subjects at 
home and held on the day of laser treatment. None of the 
devices or topicals are investigational.  
 
References: 
1. www.skinmedica.com 
2. www.clearandbrilliant.com 
3. Pandya et al. “Reliability assessment and 
validation of the Melasma Area and Severity Index 
(MASI) and a new modified MASI scoring 

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method”. Journal American Academy of 
Dermatology. Apr 16, 2010: 78-83. 
4. Fabi, S. Goldman, M. “Comparative Study of 
Hydroquinone-Free and Hydroquinone-Based 
Hyperpigmentation Regimens in Treating Facial 
Hyperpigmentation and Photoaging”. Journal of 
Drugs in Dermatology. Mar 2013: 32-37. 
5. Fabi et al. “A Randomized, Split-Face Clinical Trial 
of Low-Fluence Q-Switched Neodymium-Doped 
Yttrium Aluminum Garnet (1064 nm) Laser Versus 
Low-Fluence Q-Switched Alexandrite Laser (755 
nm) for the Treatment of Facial Melasma”. Journal 
of Cosmetic and Laser Therapy. Sept 2014. 
6. Marini, Leonardo. “Advanced film-forming gel 
formula vs spring thermal water and white 
petrolatum as primary dressings after full face 
ablative fractional CO2 laser resurfacing: A 
comparative split-face pilot study”.  
7. Makino et al. “Efficacy of Lytera 2.0 in multiple 
ethnicities compared to 4% HQ; ingredients, 
preclinical data.” JDD Dec 2016.