Investigating the Efficacy of a Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes
Phase: NA
Conditions: Skin Pigment
Sponsor: University of Texas Southwestern Medical Center

STU2021-1191, ct.gov 
 
 
 
 
 
 
Investigating the Efficacy of a Fractionated 1927nm Laser for 
Diffuse Pigmentation and Actinic Changes  
 
NCT05226104 
 
30 September 2022 
 
 
 
 
 
SPONSOR 
UT Southwestern Department of 
Plastic Surgery  
 
TESTING & AMINISTRATIVE 
FACILITY 
 
UT Southwestern Medical Center 
1801 Inwood Road 
Dallas, TX 75390-9132 
 
PRINCIPLE INVESTIGATORS 
 
Dr. Abby Culver, MD 
 
SUB-INVESTIGATORS 
 
Dr. Jeffrey Kenkel, MD 
Nicole Vingan, BS 
 
 
 
 
 
 
 

STU2021-1191, ct.gov 
 
 
 
1. Background 
Melasma is an acquired skin condition defined by symmetric hyperpigmentation, typically occurring on the face. 
It arises from hyperfunctional melanocytes that deposit excess melanin into the epidermis and dermis, resulting 
in irregular light to greyish brown macules on the skin.1-3 Studies have shown that the estimated prevalence in 
the general population exists at about 1% while higher-risk populations can reach a prevalence of up to 50%.4,5 
The condition is also noted to have female predominance, particularly during reproductive years.1,6,7 
Pathogenesis is multifactorial and not yet fully understood; however common etiologic factors that play a role 
include sun exposure, genetic influences and female sex hormones. Hormonal influences play a significant role, 
most notably seen by the increased prevalence of melasma amongst pregnant women or those who use 
hormonal therapies such as hormonal contraceptives.8-12 Melasma can occur in all skin types, however, more 
commonly affects darker skin types.13 Current management includes topical agents, chemical peels, oral agents, 
and procedural treatments such as laser and light-based devices, as well a combination of the lot to treat various 
aspects including hyperpigmentation, skin inflammation, hypervascularity and photodamage.1,14 Hydroquinone 
monotherapy and triple combination cream using hydroquinone, tretinoin and corticosteroids remain the most 
effective interventions while laser and light-based devices have been shown to be effective while carrying a 
higher risk of adverse effects.14-17 Oral tranexamic acid is a promising new systemic adjunct treatment for those 
with moderate to severe recurrent disease but requires more studies to determine its efficacy. Despite the 
numerous treatment options, management is challenging given the lack of complete understanding of the 
pathogenesis, giving way to recurrent flares. 
MOXI is a fractionated 1927 wavelength thulium non-ablative laser (f1927) developed to reduce unwanted 
pigment, improve skin texture and tone and promote new cell growth. The fractionated 1927 nm thulium non-
ablative laser is suitable for targeting epidermal lesions and has been shown to be effective in resurfacing 
photoaged skin as well as addressing pigmented lesions without exacerbation.18-25  Thus it is a very effective 
option for addressing pigment concerns and the treatment itself requires less downtime than more aggressive 
laser procedures.  
This study intends to evaluate the clinical performance of f1927 for the treatment of diffuse pigmentation 
including melasma. We hypothesize that the treatment will produce a statistically significant improvement in 
the appearance of hyperpigmentation over the course of 30 days, followed by 1-month and 3-month post-
treatment visits when compared to baseline.  
 
2. Purpose 
This single-center clinical trial is being conducted over the course of 30 days followed by 1-month and 3-month 
follow-up visits. The primary objective of this study is to assess the efficacy of f1927 when used by men and 
women with diffuse hyperpigmentation and/or melasma. 
 
3. Concise Summary of Project 
3.1. Clinical Study  
This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in 
the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving 

STU2021-1191, ct.gov 
 
 
 
f1927 treatments under an IRB approved protocol. The Principal Investigators have been selected based on 
expertise, qualifications, subject access, previous clinical research, facilities, and interest in this field of 
research. Subjects will be identified from Dr. Jeffrey Kenkel and Dr. Abby Culver’s clinical practices at the 
University of Texas Southwestern Medical Center. Subjects will be numbered sequentially in the order in 
which they qualify for entry into the study.  
These patients will receive treatment using  a f1927 device and will be treated twice over the affected areas, 
once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-
treatment. Overall assessment of the effects of f1927 treatment will be based on evaluation of standard and 
close-up photography using pre- and post-procedural photos. These photos will be identifiable full-face 
photos, and subjects will be adequately informed of such. In conjunction with the standard photographic 
assessment, subjects will also have photos taken using the H2 3D Imaging System and VISIA Imaging System 
(Canfield Scientific, Parsippany, NJ).  A quantitative assessment of the effects of treatment will be performed 
using VISIA and Vectra H2 3D facial skin analysis at 1-month and 3-months post-treatment. 
From these procedures, the improvement in diffuse pigmentary changes can be evaluated in comparison to 
pre-treatment assessments. 
3.2. Primary Endpoints 
 
Assessment of improvement in overall facial hyperpigmentation using quantitative 
measurements provided by VISIA and Vectra H2 3D analysis of photos obtained at Baseline, 1-
Month and 3-Months post-treatment to evaluate the efficacy of f1927 treatments  
o Calculate percent change from baseline in visualization and numeric analysis of brown 
and red areas utilizing the Facial Skin Analysis on Canfield’s Imaging Systems  
 
Clinician assessment of pigmentation improvement using the Physician’s Global Assessment 
Scale 
3.3. Secondary Endpoints 
 
Monitoring incidence, severity, and relatedness of adverse events throughout the study. 
 
4. Test Material Information 
4.1. Study Device Description  
The following devices will be evaluated during the study:  
 
Proprietary Name 
Device Description 
Regulatory Information 
Sciton MOXI 
Aesthetic device that utilizes a 
fractionated laser to treat 
uneven pigmentation and heal 
photodamaged skin 
 
Class II 
510(K) Number: N/A 
Regulation Number:878.4810 
 
5. Study Population and Enrollment 
5.1. Subject Enrollment 

STU2021-1191, ct.gov 
 
 
 
Healthy subjects who are interested in treatment for diffuse pigmentary changes will be recruited for the 
study through recruitment flyers and social media posts. Prospective patients will be screened to check if 
they are acceptable candidates by a delegated member of the research team. Additionally, if subjects 
express an interest in the procedure during a clinic appointment with Dr. Kenkel or Dr. Culver, he or she may 
discuss the study with them and assess the treatment area. If a subject is deemed a good candidate, Dr. 
Kenkel or Dr. Culver will connect the patient with a research coordinator or delegated member of the 
research team to answer any further questions. Subjects meeting eligibility requirements will be scheduled 
for an official screening visit.  Potential subjects will have the study explained to them, will be asked about 
their willingness to be involved in the study, and their willingness to sign an informed consent form.  
5.2. Informed Consent Form 
An IRB-approved informed consent form (ICF), explaining the purpose, design, risks and duration of the 
study, will be given to each candidate subject before participation in any study procedures. The candidate 
subject will be given as much time as needed to read the ICF and will have the opportunity to have any 
study-related questions answered to their satisfaction prior to signing the ICF.  An original signed copy for 
each subject participating in the study will be retained in the study file and each subject will receive a signed 
copy.  By signing the consent form, subjects indicate that they are willing to have their full-face photograph 
and acknowledge that these photos may be used for scientific publication. If the subjects decline permission 
to be photographed, they may not participate in the study since the photographic documentation of 
treatment outcome is an important measure of evaluation. The candidate subject will be ineligible to 
participate in this study without a signed ICF.   
5.3. Subject Identification 
Subjects will be assigned a 2-digit number, which, when used in conjunction with the clinical study ID, will 
uniquely identify every subject on the study. The number will remain with the subject throughout the study 
and should be used in all references to the individual in this study. No number will be reassigned once the 
study begins.  
5.4. Eligibility Criteria 
Inclusion Criteria 
1. 
Healthy male and female adults between 20-75 years of age. 
2. 
Fitzpatrick skin type I-IV. 
3. 
Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and 
that desire correction of this condition. 
4. 
Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact 
results to the treatment areas for the duration of the study. 
5. 
Women of childbearing potential who agree to take a urine pregnancy test at the Screening visit or 
when deemed by Investigator. Women of childbearing potential must have a negative urine 
pregnancy test and must not be lactating at Screening.  Women must be willing and able to use an 
acceptable method of birth control (see below) during the study. Women will not be considered of 
childbearing potential if one of the following is documented – postmenopausal for at least 12 
months prior to study, without a uterus and/or both ovaries, bilateral tubal ligation at least 6 
months prior to study enrollment. 

STU2021-1191, ct.gov 
 
 
 
6. 
Individuals of childbearing potential who use an acceptable method of contraception throughout 
the study. Acceptable methods of birth control include: 
 
Established use of hormonal contraception (oral, injected, implanted, patch or vaginal ring) 
 
Barrier methods with spermicide: condom or occlusive cap (diaphragm or cervical/vault 
caps) with spermicidal foam/gel/film/cream/suppository 
 
Intrauterine device (IUD) or intrauterine system (IUS) 
 
Surgical sterilization (e.g., vasectomy confirmed to be effective by sperm count check, tubal 
occlusion, hysterectomy, bilateral salpingectomy/oophorectomy) 
 
Abstinence from heterosexual intercourse, when this is in line with the preferred and usual 
lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-
ovulation methods) and withdrawal methods are not acceptable forms of contraception 
7. 
Individuals who can read, speak, write and understand English and who are willing to provide 
written informed consent. 
8. 
Individuals willing to sign a photography release. 
9. 
Individuals willing and able to cooperate with all study requirements for the duration of the study. 
Exclusion Criteria 
1. 
Fitzpatrick skin type V-VI.  
2. 
Known allergies to general skin care products. 
3. 
Sensitivity to topical lidocaine or ester-based local anesthetics. 
4. 
Active systemic or local conditions that may affect wound healing. 
5. 
Current or recent history of inflammatory skin disease, infection or unhealed wound in the 
proposed treatment area(s). 
6. 
History of systemic granulomatous diseases, either active or inactive, (e.g., Sarcoid, Wegener’s, TB, 
etc.) or connective tissue diseases (e.g., lupus, dermatomyosistis, etc.). 
7. 
Recent history of significant trauma to the areas to be treated (< 6 months). 
8. 
Significant scarring, other than acne scars, in the area(s) to be treated. 
9. 
Current or history of hypertrophic scarring or keloid scars. 
10. Severe or cystic and clinically significant acne on the area(s) to be treated. 
11. Tattoos in the area to be treated. 
12. Observable suntan, nevi, excessive hair, etc. or other dermal conditions on the treatment area(s) 
of the face that might influence study results in the opinion of the Investigator. 
13. Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated 
and/or with a history of skin cancer. 
14. Individuals with skin pathology and/or pre-existing dermatologic condition in the treatment area 
(i.e., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation 
conditions such as post inflammatory hyperpigmentation) that the Investigator deems 
inappropriate for participation or could interfere with outcomes of the study. 
15. History of chronic drug or alcohol use. 
16. Microdermabrasion or glycolic acid treatment to the treatment area(s) within 4 weeks of study 
participation or who plan on having this treatment during the study. 
17. History of the following cosmetic treatments in the area(s) to be treated: 
 
Injectable filler of any type within the past 2 weeks 
 
Neurotoxins within the past week 

STU2021-1191, ct.gov 
 
 
 
 
Ablative resurfacing laser treatment within the past 6 months  
 
Non-ablative, rejuvenative laser or light treatment within the past 6 months 
 
Chemical peel or dermabrasion within the past 3 months  
18. Individuals undergoing concurrent therapy that, in the Investigator’s opinion, would interfere with 
the evaluation of the safety or efficacy of the study devices. 
19. History of using the following prescription medications: 
 
Accutane or other systemic retinoids within the past 6 months 
 
Topical retinoids within the past 4 weeks 
 
Prescription strength lightening devices (e.g., hydroquinone, tretinoin, AHA, BHA, poly-
hydroxy acids, 4-hydroxyanisole alone or combined with tretinoin, etc.) within 4 months 
 
Any anti-wrinkle or skin lightening devices, or topical or systemic medication known to 
affect skin aging or dyschromia (e.g., devices containing alpha/beta/polyhydroxy acids, 
Vitamin C, soy, Q-10, hydroquinone, systemic or licorice extract (topically), Tego ®, Cosmo 
C250, gigawhite, lemon juice extract (topically), embilica extract, etc.) within 2 weeks 
 
Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use), and/or 
 
Psychiatric drugs that, in the Investigator’s opinion, would impair the subject from 
understanding protocol requirements or understanding and signing consent.  
20. Individuals who are pregnant or nursing or those planning on becoming pregnant during the study 
according to self-report. 
21. Immunocompromised individuals or those currently using immunosuppressive medications and/or 
radiation. 
22. Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically 
significant hypertension, or hypothyroidism. Those with multiple health conditions may still be 
excluded from participation even if conditions are controlled. 
23. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical 
procedures planned during the course of the study. 
24. Individuals who, in the Investigator’s opinion, have a history of poor cooperation, unreliability or 
noncompliance with medical treatment. 
25. Individuals who are unable to understand instructions or give informed consent 
26. Individuals who have physical or psychological conditions which, in the opinion of the Investigator, 
makes them unable to complete the study per protocol (e.g., not likely to avoid other cosmetic 
treatments to area; not likely to stay in study for entire duration due to other commitments; or 
those with concomitant conditions that may develop symptoms that might confuse or confound 
study treatments or assessments). 
 
6. Subject Instructions 
Subjects will be asked to wash off all skincare products at least 30 minutes prior to each scheduled clinic visit 
using a cleanser of your choice. No other topical products should be applied to the treatment area until the 
study visit has been completed. If a subject arrives having not removed skincare products, she or he will be 
required to remove the residual product at the clinic and wait at least 20 minutes prior to procedures. 

STU2021-1191, ct.gov 
 
 
 
Blistering, bleeding, oozing, strong pain, swelling persisting for more than 24 hours, or signs of infection 
(e.g., pus, drainage, fever) are cause for immediate concern and you should contact the investigator and/or 
his designee to be evaluated and potentially treated at no cost to the subject.  
Subjects will be asked to avoid extended periods of sun exposure and all use of tanning beds for the 
duration of the study. Extra care should be taken to wear protective clothing and avoid sun exposure from 
10 AM to 4 PM.  
Subjects will be encouraged to consistently use face wash, moisturizer, and sunscreen of their choosing. 
Subjects will be asked to refrain from using any new anti-aging, acne, and acne scar products or devices and 
beginning the use of any new skincare products or devices other than the assigned test material for the 
duration of the study.   
7. Study Design 
7.1. Outline of Procedures  
Procedures/ 
Time Points: 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Screening 
(-30 to 0 days) 
Baseline/ 
Treatment #1* 
(Day 0 ; + 3 days) 
Treatment #2 
(Day 30; + 3 days) 
1-month 
post-treatment 
(+ 3 days) 
3-months 
post-treatment 
(+ 3 days) 
Informed Consent 
X 
 
 
 
 
Enrollment 
Paperwork 
X 
 
 
 
 
Medical History/ 
Concomitant 
Medications 
X 
X 
X 
X 
X 
Pregnancy Test 
X 
 
 
 
 
MOXI Treatment 
 
X 
X 
 
 
Standard 
Photography 
X 
 
 
X 
X 
H2 3D and VISIA 
Photography 
X 
 
 
X 
X 
Physician’s Global 
Assessment Scale 
 
 
 
X 
X 
Safety 
Assessment 
 
X 
X 
X 
X 
 
* Treatment #1 (Visit 2) activities may be conducted at the Screening visit (Visit 1) 
7.2. Pre-Study Procedures 
Prior to the start of the study, potential subjects will be screened for eligibility requirements via chart review 
on EPIC. Prospective subjects will be informed of study details and study visit instructions as detailed in 
section 6. An appointment to visit the clinic for an official screening visit will be scheduled if interest is 
demonstrated. Additionally, if subjects express an interest in the procedure during a clinic appointment with 
Dr. Kenkel or Dr. Culver, he/she may discuss the study with them and assess the treatment area. If a subject 
is deemed a good candidate, they will be connected to a research coordinator to answer any further 
questions and provide consent. 
7.3. Screening: Visit 1 (Day 0; -14 to 0 days) 

STU2021-1191, ct.gov 
 
 
 
The purpose of the study, eligibility criteria and potential risks will be discussed with the potential subject. 
All interested candidates will be given an IRB approved Informed Consent Form (ICF) as detailed in section 
5.2, with adequate time for review. The Investigator and/or designee will address questions and/or concerns 
raised by the subject. Those subjects who elect to participate will sign the consent form prior to any study 
procedures. The subject will receive a signed copy of their ICF and the original will be kept in the study file. 
Subjects will then be screened to ensure they meet all study criteria.  
The following is a complete list of the screening and enrollment activities to be performed: 
1. Obtain informed consent and HIPAA authorization. 
2. Assign a screening number to candidate subjects that sign the initial paperwork. 
3. Collect a brief medical history including current medications, skin type, allergies, major 
conditions, or illnesses, etc. and assess if subjects meet eligibility criteria. 
4. For those that pass eligibility requirements and are females of childbearing potential, perform a 
urine pregnancy test. If the test is negative or candidate is male, the subject will be enrolled in 
the study and assigned a subject number.  
5. Obtain close up and standard photography as described in section 8.1.  
6. Obtain photographs and measurements using the Vectra H2 3D Imaging System and VISIA 
Imaging System as described in section 8.1. 
 
 
This visit will take 30-45 minutes. Screening (Visit 1) may be combined with Visit 2.  
7.4. Treatment Visits: Visit 2 (Day 0; +/-3 days) and Visit 3 (Day 30; +/-3 days) 
A member of the study team will record concomitant medications and will ask subjects if they have 
experienced any changes in their health since the previous visit. If an adverse event (AE) is reported than the 
Investigator will be informed, and an AE log will be completed/updated for PI review. 
The following activities will be completed before the treatment:  
1. The physician or study staff will ask subjects if they have experienced any changes in their health 
since the previous visit. Changes will be recorded accordingly. If an adverse event (AE) is 
reported than the Investigator will be informed, and an AE form will be completed. 
2. Subjects will acclimate to ambient temperature and humidity conditions for 15 minutes prior to 
any procedures being done. 
The procedure will then be performed in our Plastic Surgery clinic following standard of care procedures. A 
trained staff member will apply a topical triple anesthetic (benzocaine, lidocaine, tetracaine) to anesthetize 
the areas being treated. After allowing 10 minutes for the anesthetic to take effect, the skin will be cleansed 
and prepped with antiseptic. A trained staff member will treat the subject’s face with f1927. Treatment 
settings and parameters will be determined by the provider and will be chosen according to Fitzpatrick skin 
type and location of the body for which it will be used. Ultimately, 4-6 passes will be performed at the 
discretion of the provider. 
Appropriate post-treatment care instructions will be provided as deemed appropriate by the Investigator or 
study staff. Post treatment assessment will be performed.  Subjects will be instructed that blistering, 

STU2021-1191, ct.gov 
 
 
 
bleeding, oozing, strong pain, swelling persisting for more than 72 hours, or signs of infection (e.g., pus, 
drainage, fever) are cause for immediate concern and they should contact the investigator and/or his 
designee, to be evaluated.  Expected downtime is minimal after treatment, typically lasting 0-3 days. 
These visits will take approximately 1 hour.  
7.5. Follow-Up Visits: Visit 4 (1-Month Post Treatment) and Visit 5 (3-Months Post Treatment)  
At a minimum, all subjects will return for follow-up visits at 1 month (+/- 3 days) and 3 months (+/-3 days) 
after treatment. 
The following activities will be performed on all study subjects during the follow-up visits:   
1. The physician or study staff will ask subjects if they have experienced any changes in their 
health since the previous visit. Changes will be recorded accordingly. If an adverse event (AE) is 
reported than the Investigator will be informed, and an AE form will be completed. 
2. Subjects will acclimate to ambient temperature and humidity conditions for 15 minutes prior to 
any procedures being done. 
3. The physician or study staff will perform an examination of the skin in the treatment area 
4. Obtain post-treatment close up and standard photography as described in section 8.1.  
5. Obtain post-treatment photographs and measurements using the Vectra H2 3D Imaging System 
and VISIA Imaging System as described in section 8.1. 
 
These visits will take about 30 minutes. 
8. Assessments 
8.1. Photography Procedures 
Prior to photography procedures, clinic personnel will ensure that the subjects have clean faces with no 
makeup or skincare products as described in the study procedures. Subjects will remove any jewelry from 
the area(s) to be photographed and equilibrate for at least 15 minutes to ambient conditions within the 
clinic before any photographs are taken. Subjects will be provided with a headband or hair tie to keep hair 
away from the face. 
1. 
NIKON D7200 
Standard, close up and cross-polarized photography of the face will be utilized for evaluation of 
pigmentation. These photographs will be taken utilizing the Nikon D7200 at Baseline, 1-month 
post treatment and 3-months post treatment. 
2. 
Vectra H2 3D Imaging System 
Subjects will be instructed to adopt neutral, non-smiling expressions for each photograph. Images 
will be taken of each applicable subject with diffuse pigmentation of the face using the Vectra H2 
3D Imaging System at Baseline, 1-month post-treatment and 3-months post-treatment. Each 
subject will have a total of 3 photos taken (right side, left side and center view). 
3.     VISIA Imaging System 

STU2021-1191, ct.gov 
 
 
 
 
Subjects will be instructed to adopt neutral, non-smiling expressions with their eyes gently 
closed for each photograph. Images will be taken of each applicable subject using the VISIA Imaging 
System at Baseline, 1-month post-treatment and 3-months post-treatment. Subjects will be carefully 
positioned for each photograph, directly facing the camera for the center view and turned at a 45-
degree angle for the right and left side views. The scan is objectively able to measure spots, wrinkles, 
texture, pores, UV spots, brown spots, red areas and porphyrins.  
8.2 Physician’s Global Assessment  
Trained clinician reviewers will use the Physician’s Global Assessment Scale to evaluate subject’s clinical 
photography and assess melasma response to f1927 laser treatment. Reviewers will be presented with 
baseline or follow-up photos and will use the attached scale to score individual subjects’ improvement. 
 
 
9. Statistical Methods of Analysis 
The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will 
include all subjects who received treatment and completed the study in general accordance with the protocol. 
Only the data of completing subjects will be analyzed. 
This study will include descriptive statistics and change from baseline analysis.  
The primary outcome of effectiveness will be a paired comparison of baseline to all applicable post-baseline 
time points for hyperpigmentation and melasma severity using data obtained from Vectra H2 3D imaging 
results. 

STU2021-1191, ct.gov 
 
 
 
A descriptive statistical summary will be provided the VISIA, Vectra H2, and Physician’s Global Assessment Scale. 
The descriptive statistical summary includes the number of observations (N), mean, median, and standard 
deviation (SD), minimum (MIN) and maximum (MAX) values at all applicable time points. 
The following will be calculated and reported for each evaluation parameter at the applicable post-baseline time 
point(s): 
Percent Mean Change from Baseline = 
(Visit Mean Score – Baseline Mean Score) x 100 
Baseline Mean Score 
 
For each new measurement set we will conduct a repeated measures of analysis of variance to detect difference 
between sample distributions. If differences are detected, we will subsequently evaluate specific pairwise 
comparisons among the post treatment visit times using a paired T-test or Wilcoxon signed-rank tests.   All 
statistical tests will have a significance level alpha =0.05. P-values will be reported to 3 decimal places (0.000). 
 
10. Potential Risks 
Blistering, burning, scaling and infection (Rare) 
A crust, blister or superficial wound can occur in the treatment area. The risk of infection will be minimized 
by proper wound care. 
Bruising (Rare) 
A mild bruising may occur at the treatment area. This is usually transient and resolves in a few hours to few 
days. 
Transient edema and/or erythema (Common) 
Edema and erythema typically develop within the irradiated areas but are usually temporary and fade within 
24-72 hours. There is a 90% chance of transient edema and 99% chance of erythema to occur after 
treatment. 
Skin roughness and/or peeling (Common) 
Patients can expect their treated skin to feel rough like sandpaper for a few days while the skin heals. This is 
transient and should resolve in a few days. This is specific to the f1927 treatment.   
Pigmentary changes (Rare) 
This treatment can cause undesired pigmentary changes such as hyper or hypopigmentation. Although this 
is usually temporary, it may be permanent on rare occasions. Sun avoidance and/or the use of total sun 
block (SPF 30 or higher) will help to minimize the intensity and duration of pigmentary changes. 
Eye injury (Rare) 
There is a risk of eye injury associated with the use of this device. This risk will be minimized by wearing 
protective eyewear designated for use with this device. All subjects and other personnel must use proper 
protective eyewear during the use of this device  

STU2021-1191, ct.gov 
 
 
 
Scarring (Rare) 
There is a small risk of scarring. However, this is minimized by proper technique and wound care. 
Allergic reaction (Rare) 
There is a possibility of an allergic or toxic reaction to the anesthesia used to the numb the treatment areas. 
Subjects will be questioned with regard to any history of allergies and carefully monitored for signs of 
allergic or toxic reaction. 
Photography 
The subject may be uncomfortable with sitting still for an extended period of time or from turning his/her 
body in various positions. Subjects may be sensitive to bright and repeating flashes from the camera, which 
can sometimes cause headaches, eye irritation, discomfort, aftereffects such as seeing spots, and in rare 
cases, could stimulate a migraine headache or epileptic seizure. 
Photographs include a risk of identification, as these will be full face photos. Privacy will be protected to the 
greatest extent possible. Photos will only be identified by unique subject identification number that contains 
no personal identifying information. All photos will be stored on a password secure drive, with only access 
by research personnel. For research purposes, photos may be used in scientific publications. 
Subject will be instructed that blistering, bleeding, oozing, strong pain, swelling persisting for more than 24 
hours, or signs of infection (e.g., pus, drainage, fever) are cause for immediate concern and they should 
contact the investigator and/or his designee, to be evaluated.  Downtime after treatment typically can last 
approximately 0-3 days.  After about three days, there is rarely any evidence that the procedure has taken 
place.   
Symptoms of mild irritation, including the examples discussed above, will not be treated as adverse 
reactions if they are mild in nature. These conditions may or may not resolve over time. Symptoms that are 
persistent and moderate to severe in nature, or that involve elevation (e.g., edema, papules, vesicles, 
spreading) will be considered AEs.  The Investigator will have the final determination as to whether a 
reaction will be considered an AE. 
11. Adverse Events  
At each visit, the Investigator will question the subject about adverse events using an open-ended question. If a 
potential adverse event is reported by the subject or identified during examination, directed questioning and 
examination will be performed when appropriate. At this time, the following will be performed: 
1. Obtain a complete history of the event in question as well as conduct an examination of the 
subject and determine if the reported event qualifies as an Adverse Event (AE). If the event is 
determined to be an AE, an AE case report form and Event Follow-up (EF) visit case report form 
must be completed. One AE case report form should be used to track the history of an individual 
AE throughout the period of the study. 
2. Collect an updated medical and surgical history along with recording of concomitant 
medications or treatments. 
3. Take photographs of the subject with attention to the area in question. 

STU2021-1191, ct.gov 
 
 
 
4. Render treatment for the event, if any, as determined by the medical judgement of the 
Investigator.  
Photographs will be taken to document any AEs if possible. 
For the duration of the study, medical assistance will be provided to the subject for study-related problems at no 
expense, if in the opinion of the Investigator, the reaction was caused by MOXI treatments. Should a subject 
choose to seek their own medical treatment, no reimbursement will be offered.  
When an AE persists at the end of the study, the Investigator will ensure a follow-up of the subject until the 
Investigator believes that the event is satisfactorily resolved.  
12. Subject Safety and Data Monitoring  
12.1. 
Research Standards/Good Clinical Practice 
The conduct of this study will follow all applicable guidelines for the protection of human subjects for 
research as outlined in 21 CFR 50, in accordance with the accepted standards for Good Clinical Practice 
(GCP), International Conference on Harmonization (ICH), and the standard practices of UT Southwestern. 
12.2. 
Data Monitoring 
For this protocol, which involves the use of a non-significant risk device, the Investigator will monitor 
accrual, subject experience, attrition, patterns of adverse events and/or unexpected adverse events, any 
protocol deviations, or violations any changes in the risk/benefit analysis.   
Subjects will be asked about any adverse events throughout the study. Subjects will be asked to contact the 
Investigator if adverse events develop between visits.  If necessary, an unscheduled visit will be arranged so 
that the Investigator can clinically evaluate and photograph these findings. 
12.3. 
Procedures to Maintain Confidentiality 
All study records and information will be identified by the subject number. All subject identifiers will be 
removed from all documents. The link between subject name and study ID number will be kept in separate 
password-protected files. Documents containing identifying information will be kept in locked files in the 
research staffs’ locked office. All electronic study data will be password protected with access limited to 
members of the research team.  No direct identifying information will be shared with any outside entities.  
Electronic data (electronic data entry - Case Report Forms) will be password protected.   
Photographs of subject’s faces will be taken at enrollment, treatment, and follow-up visits. These 
photographs will be identified by subject numbers. Subject confidentiality will be protected to the greatest 
extent possible 
This study will be performed in accordance with Health Insurance Portability and Accountability Act. These 
guidelines will be followed specifically with regard to the privacy and confidentiality of patient care and 
study records. Personnel associated with Investigator’s office, the U.S. Food and Drug Administration (FDA) 
and the governing Institutional Review Board, have the right to review the data, including photographs, 
collected during this study. 
 
13. References 

STU2021-1191, ct.gov 
 
 
 
1. 
Ogbechie-Godec OA., Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther 
(Heidelb). 7(3):305-318. doi:10.1007/s13555-017-0194-1 
2. 
Grimes PE, Yamada N, Bhawan J. Light microscopic, immunohistochemical, and ultrastructural 
alterations in patients with melasma. Am J Dermatopathol. Apr 2005;27(2):96-101. 
doi:10.1097/01.dad.0000154419.18653.2e 
3. 
Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. Dec 1995;131(12):1453-
7. doi:10.1001/archderm.131.12.1453 
4. 
Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. Mar 
2006;45(3):285-8. doi:10.1111/j.1365-4632.2004.02470.x 
5. 
Taylor SC. Epidemiology of skin diseases in ethnic populations. Dermatol Clin. Oct 2003;21(4):601-7. 
doi:10.1016/s0733-8635(03)00075-5 
6. 
Hexsel D, Lacerda DA, Cavalcante AS, et al. Epidemiology of melasma in Brazilian patients: a multicenter 
study. Int J Dermatol. Apr 2014;53(4):440-4. doi:10.1111/j.1365-4632.2012.05748.x 
7. 
Vázquez M, Maldonado H, Benmamán C, Sánchez JL. Melasma in men. A clinical and histologic study. Int 
J Dermatol. Jan-Feb 1988;27(1):25-7. doi:10.1111/j.1365-4362.1988.tb02329.x 
8. 
Achar A, Rathi SK. Melasma: a clinico-epidemiological study of 312 cases. Indian J Dermatol. Jul 
2011;56(4):380-2. doi:10.4103/0019-5154.84722 
9. 
Handel AC, Lima PB, Tonolli VM, Miot LD, Miot HA. Risk factors for facial melasma in women: a case-
control study. Br J Dermatol. Sep 2014;171(3):588-94. doi:10.1111/bjd.13059 
10. 
Rodríguez-Arámbula A, Torres-Álvarez B, Cortés-García D, Fuentes-Ahumada C, Castanedo-Cázares JP. 
CD4, IL-17, and COX-2 Are Associated With Subclinical Inflammation in Malar Melasma. Am J Dermatopathol. 
Oct 2015;37(10):761-6. doi:10.1097/dad.0000000000000378 
11. 
Bak H, Lee HJ, Chang SE, Choi JH, Kim MN, Kim BJ. Increased expression of nerve growth factor receptor 
and neural endopeptidase in the lesional skin of melasma. Dermatol Surg. Aug 2009;35(8):1244-50. 
doi:10.1111/j.1524-4725.2009.01219.x 
12. 
Ortonne JP, Arellano I, Berneburg M, et al. A global survey of the role of ultraviolet radiation and 
hormonal influences in the development of melasma. J Eur Acad Dermatol Venereol. Nov 2009;23(11):1254-62. 
doi:10.1111/j.1468-3083.2009.03295.x 
13. 
Grimes P. Melasma: Epidemiology, pathogenesis, clinical presentation, and diagnosis. In: Dellavalle R, 
Alexis A, Corona R, eds. UpToDate. 
14. 
McKesey J, Tovar-Garza A, Pandya AG. Melasma Treatment: An Evidence-Based Review. Am J Clin 
Dermatol. Apr 2020;21(2):173-225. doi:10.1007/s40257-019-00488-w 
15. 
Bilaç C, Şahin MT, Öztürkcan S. Chronic actinic damage of facial skin. Clin Dermatol. Nov-Dec 
2014;32(6):752-62. doi:10.1016/j.clindermatol.2014.02.014 
16. 
Fleming J, Bashir S. Combination (5% Hydroquinone, 0.1% Tretinoin and 1% Hydrocortisone) Cream in 
Treating Facial Hyperpigmentation: A Retrospective Patient Satisfaction Survey. Journal of Cosmetics, 
Dermatological Sciences and Applications. 2014;04:329-331.  
17. 
Bandyopadhyay D. Topical treatment of melasma. Indian journal of dermatology. 2009;54(4):303-309. 
doi:10.4103/0019-5154.57602 
18. 
Brauer JA, McDaniel DH, Bloom BS, Reddy KK, Bernstein LJ, Geronemus RG. Nonablative 1927 nm 
fractional resurfacing for the treatment of facial photopigmentation. J Drugs Dermatol. Nov 2014;13(11):1317-  
19. 
Chang HS, Lim NK. Clinical Applications of a Non-ablative Fractional Dual Laser (1550/1927 nm). Medical 
Lasers. 2020;9(2):110-118. doi:10.25289/ML.2020.9.2.110 
20. 
Geddes ER, Stout AB, Friedman PM. Retrospective analysis of the treatment of melasma lesions 
exhibiting increased vascularity with the 595-nm pulsed dye laser combined with the 1927-nm fractional low-
powered diode laser. Lasers Surg Med. Jan 2017;49(1):20-26. doi:10.1002/lsm.22518 
21. 
Polder KD, Bruce S. Treatment of melasma using a novel 1,927-nm fractional thulium fiber laser: a pilot 
study. Dermatol Surg. Feb 2012;38(2):199-206. doi:10.1111/j.1524-4725.2011.02178.x 

STU2021-1191, ct.gov 
 
 
 
2225. Polder KD, Harrison A, Eubanks LE, Bruce S. 1,927-nm fractional thulium fiber laser for the treatment of 
nonfacial photodamage: a pilot study. Dermatol Surg. Mar 2011;37(3):342-8. doi:10.1111/j.1524-
4725.2011.01884.x 
2326. Preissig J, Hamilton K, Markus R. Current Laser Resurfacing Technologies: A Review that Delves Beneath 
the Surface. Seminars in plastic surgery. 2012;26(3):109-116. doi:10.1055/s-0032-1329413 
2427. Brauer JA, Alabdulrazzaq H, Bae YS, Geronemus RG. Evaluation of a Low Energy, Low Density, Non-
Ablative Fractional 1927 nm Wavelength Laser for Facial Skin Resurfacing. J Drugs Dermatol. Nov 
2015;14(11):1262-7.  
25. 
Chan CS, Saedi N, Mickle C, Dover JS. Combined treatment for facial rejuvenation using an optimized 
pulsed light source followed by a fractional non-ablative laser. Lasers Surg Med. Sep 2013;45(7):405-9. 
doi:10.1002/lsm.22162