Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes
Phase: NA
Conditions: Pigment Skin
Sponsor: University of Texas Southwestern Medical Center

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Combining broad based light, fractionated 1927 and dual wavelength 
2940/1470 for diffuse pigmentation, texture and actinic changes 
 
NCT06091215 
10/21/24 
 
 
 

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Combining broad based light, fractionated 1927 and dual 
wavelength 2940/1470 for diffuse pigmentation, texture and actinic 
changes 
 
Sponsor Sciton 
PI Dr. Jeffrey Kenkel, MD 
Facility UT Southwestern Medical Center 
Site Department of Plastic Surgery 
1801 Inwood Road 
5th Floor 
Dallas, TX 75390-9132 
 
 
ClinicalTrials.gov Identifier: NCT06091215 
 
 
 

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Background  
Skin concerns encompass a range of issues, including photodamage, dyspigmentation, UV spots, brown spots, red 
birthmarks, broken blood vessels, and overall skin texture and appearance. Various devices and technologies have been 
developed to address these concerns, including broad-based light therapy, fractionated laser, ablative lasers, and 
nonablative lasers. 
 
Broad-Based Light (IPL): Berlin et al. (2007) demonstrated the effectiveness of combining superficial Er:YAG ablative 
treatments and nonablative BBL (Intense Pulsed Light) treatments, leading to significant clinical improvements in 
photodamaged skin, enhanced collagen formation, and high patient satisfaction. Siperstein (2021) also demonstrated the 
safety and efficacy of BBL in improving the clinical appearance of senile purpura and reducing ecchymoses, making it a 
versatile treatment option. 
 
MOXI (Fractionated Non-Ablative Thulium 1927 nm Laser): Vingan et al. (2023) highlighted the effectiveness and 
safety of non-ablative 1927 nm laser treatments in improving dyspigmentation, particularly in Fitzpatrick skin types I-IV, 
with a statistically significant reduction in spots and brown spots sustained over three months. Li et al. (2023) found that 
the 1927 nm fractional thulium fiber laser (FTL) effectively addressed photoaging, with significant improvements in 
various parameters and high patient satisfaction. Current studies are exploring the efficacy of this laser in Fitzpatrick skin 
types V-VI. 
 
HALO (Dual Fractionated Hybrid Laser): Kislevitz et al. (2020) observed significant improvements in skin appearance 
after a single treatment with the 1,470/2,940 nm HALO laser, particularly in reducing UV spots and brown spots. 
Additionally, a study by Waibel et al. (2018) involving Fitzpatrick skin types I-IV demonstrated high patient satisfaction, 
significant skin improvement, and minimal adverse events when using this hybrid fractional laser for photodamaged skin. 
 
The combined use of these lasers represents a novel approach to addressing diverse skin care goals. To our knowledge, 
this is the first study to investigate the combined effects of these three modalities on skin rejuvenation and overall skin 
health in a single setting.  
 
Device 
Characteristics Wavelength  
Target  
Previous Studies 
BBL  
Broad based light   
(BBL HERO) 
  
IPL 
Nonablative 
 
Freckles  
Age Spots  
Cherry Angiomas  
Rosacea  
Dull complexion  
Acne  
Skin Laxity  
Unwanted hair  
Berlin et al  2007  
  
Siperstein et al  2021  
  
Handler et al 2017  
  
MOXI  
Fractionated thulium 
Nonablative  (1927 nm laser) 
Pigmentation  
Sun damage (UV spots) 
Signs of aging (brown spots) 
Vingan et al . 2023  
  
Li et al 2023  
HALO  
Dual fractionated hybrid laser  
Non-ablative (1470 nm) & Ablative (2940 
nm) 
Fine lines & Wrinkles  
Sun damage & dyschromia  
Scar revision  
Pigmented lesions  
Enlarged pores  
Kislevitz et al  2020   
  
Waibel et al 2018  
 
Purpose 
This single-site clinical trial is being conducted over the course of 4 to 6 months.  Healthy subjects will receive 1-2 
treatments combining BBL/MOXI/HALO during this trial and be followed up 1 month and 3 months after their final 
treatment to assess noted changes. 
 
The primary objective of the study is to assess the efficacy of this BBL/MOXI/HALO combination treatment. 
 

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Project Summary 
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.  The study is designed to follow up to 15 consenting subjects who may receive up to 2 
BBL/MOXI/HALO treatments under an IRB approved protocol. The BBL/MOXI/Halo treatments are all within the Joule 
System and is used as separate or combination treatments as part of standard of care within the clinic. 
 
The Principal Investigator (PI) has been selected based on expertise, qualifications, previous clinical research and interest 
in this field of research.  Subjects will be identified and recruited from the clinic of plastic surgery at UT Southwestern 
Medical Center.   
 
Subjects will be consented by a member of the research team and subjects will be numbered in the order that consent is 
obtained, and all assessments and documents will contain the assigned ID for the duration of the study.  Subjects will 
receive 1-2 BBL/MOXI/HALO treatments.  All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to 
ensure the skin has enough time to recover.  Overall assessments will be collected before the first treatment and at 
subsequent follow-up visits at 1 Month and 3 Months post final treatment.  Identifiable full-face standard and close-up 
photography will be obtained and used to evaluate any changes.  Subjects will also have photos obtained with the VISIA-
CR Imaging System (Canfield Scientific, Parsippany, NJ).  Quantitative analysis will be completed on the VISIA imaging 
system and be used to compare the effects of the treatments.  Any improvements will be evaluated to pre-treatment 
assessments. 
 
Primary Endpoints 
Assessment of changes by VISIA Imaging System of photos obtained pre-treatment, 1 Month and 3 Months 
post-treatment. 
▪ 
Calculate percent change from baseline in numeric analysis via the VISIA Imaging System 
▪ 
VISIA- CR Imaging system will be utilized to capture qualitative and quantitative data including, 
but not limited to: spots, wrinkles, texture, pores, UV spots, brown spots, red areas and 
porphyrins.  
▪ 
Clinician assessment of improvement using the Global Aesthetic Improvement Scale. 
 
Secondary Endpoint 
Monitor incidence, severity and relatedness of adverse events throughout the study. 
 
Study Device Information 
 
Proprietary Information 
Device Description 
Regulatory Information 
Device 
Name: 
JOULE 
Multi-
Platform 
System 
Sciton BBL 
HERO 
Aesthetic device utilizing broadband light to 
improve the appearance of aging, reduces 
rosacea, acne, melasma and sun spots 
Class II 
510(K) Number: N/A 
Regulation number: 
878.4810 
Sciton MOXI 
Aesthetic laser device that utilizes a 
fractionated laser to treat uneven 
pigmentation and heal photodamage skin 
Sciton HALO 
Aesthetic laser device that utilizes a hybrid 
fractionated laser to treat fine lines & 
wrinkles and reduce the appearance of 
enlarged pores, sun damage and dyschromia 
 
Study Population & Enrollment 
Enrollment 

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Healthy subjects who are interested in being treated with BBL/MOXI/HALO will be recruited for the study through the 
Plastic Surgery Clinic at UT Southwestern.  Subjects may include UTSW patients, employees, students and the general 
population.  Prospective subjects will be screened by a member of the research team delegated by the PI in clinic or via a 
phone call.  If the subject is deemed to be a good candidate for the study based off the eligibility criteria, a clinic 
appointment will be made where a member of the research team will explain the purpose of the study and all the 
procedures and assessments that will be completed.  The subject will be given time to consider their participation in the 
study before the informed consent is signed. 
 
Informed Consent Form 
An IRB-approved informed consent form (ICF) will be provided to each prospective subject during the study teams initial 
contact with the subject.  The ICF will contain information explaining the purpose, design, risks and duration of the study.  
The candidate will be given as much time as necessary to read the form and discuss the study with their family or doctor.  
Study team will answer any study-related questions to their satisfaction prior to signing of the ICF.  An original signed 
copy will be filed in the subjects study file and a copy will be provided to the subject.  Additionally, a scanned copy of the 
ICF will be included in the subjects electronic record. 
 
Subject Identification 
All subjects will be assigned a unique study ID and 2-digit number which will be used on all files and assessments to 
identify the subject.  The ID will consist of a unique clinical study ID and the 2-digit number will be the sequential order 
of subject enrollment.  The ID will remain with the subject throughout the study and should be used in all references to the 
individual.  No ID will be reassigned once the study begins and the ID will not contain any identifiable subject 
information.   
 
Eligibility Criteria 
Inclusion Criteria: 
1. Healthy male and female adults between 20-75 years of age 
2. Fitzpatrick skin type 1-4 
3. Individual deemed by the Investigator to benefit from skin resurfacing treatment(s) 
4. Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the 
duration of the study 
5. Women of childbearing potential: 
5.1. will be asked to agree to a pregnancy test before their screening visit in clinic 
5.2. must use an acceptable method of birth control 
• 
Hormonal contraception (oral, injected, implanted, patch or vaginal ring) 
• 
Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository 
• 
Intrauterine device (IUD) 
• 
Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral 
salpingectomy/oophorectomy) 
• 
Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the 
subject.  Periodical abstinence and withdrawal methods are not acceptable forms of contraception. 
6. Individuals who can read, speak, write and understand English and who are willing to provide written informed 
consent. 
7. Individuals willing to sign a photography release with the understanding that their photos may be used during 
presentations at national conferences and/or published in journals 
8. 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 local anesthetic 
4. Current or recent history of skin diseases: 

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• 
Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or 
connective tissue diseases (e.g., lupus, dermatomyositis, etc.) 
5. Significant scars in the treatment area: 
• 
Severe or cystic and clinically significant acne or acne scars on the areas to be treated 
• 
Current or history of hypertrophic scarring or keloid scars 
6. Tattoos in the area to be treated 
7. Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face 
in the opinion of the Investigator 
8. Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated 
9. Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate 
for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic 
dermatitis, vitiligo, etc. 
10. History of chronic drug or alcohol use 
11. Recent aesthetic treatments: 
• 
<4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this 
treatment during the study 
• 
<2 weeks of any type of injectable filler 
• 
<1 week of neurotoxin’s 
• 
<6 months of ablative resurfacing laser treatments 
• 
<6 months of non-ablative, rejuvenative laser or light treatment 
• 
<3 months of chemical peels or dermabrasion 
12. Use of the following prescription medications: 
• 
<6 weeks of Accutane or other systemic retinoids on the treatment area 
• 
<4 weeks of topical retinoids 
• 
<4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, 
poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin) 
• 
<2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or 
dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, 
Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract 
• 
Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use) 
• 
Psychiatric drugs that would impair the subject from understanding protocol requirements or 
understanding and signing the ICF. 
13. Individuals who are pregnant or planning to become pregnant during the course of the study 
14. Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation 
15. Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, 
or hypothyroidism.  
16. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during 
the course of the study. 
17. Individuals who, in the Investigator’s opinion, have a history of poor cooperation, unreliability or noncompliance with 
medical treatment. 
18. Individuals who are unable to understand instructions or give informed consent 
19. Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them 
unable to complete the study per protocol.

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Study Timeline 
Outline of Visits 
 
Single Treatment Arm  
Study Procedures 
Visit 1 
Screening 
 
 
(Day -45 to 0) 
Visit 2 
Treatment  #1 
 
 
(Day 0) 
Visit 3 
Follow-Up #1 
PI Assessment 
Tx1 1M 
(Day 30)  
Visit 4 
Follow-Up #2 
 
Tx1 3M 
(Day 90)  
Demographic & Eligibility  
 
Informed Consent ; Eligibility Criteria  
Medical History & Demographics  
X 
 
 
 
Safety Assessments    
Adverse Events; Concomitant Medications  
 
X 
X* 
X 
Study Intervention  
BBL /MOXI/ Halo  
 
X 
 
 
Assessments  
Standard Photography; VISIA 
Imaging/Analysis  
X 
 
x 
X 
Evaluations  
Global Aesthetic Improvement Scale 
 
 
 
X 
 
Dual Treatment Arm 
Study Procedures 
Visit 1 
Screening 
 
(Day -45 to 0) 
Visit 2 
Treatment #1 
 
(Day 0) 
Visit 3 
Follow-Up #1 
PI Assessment 
(Day 30) 
Visit 4 
Treatment #2 
 
(Day 45) 
Visit 5 
Follow-Up #2 
Tx2 1M 
(Day 75) 
Visit 6 
Follow-Up #3 
Tx2 3M 
(Day 135) 
 
Demographic & 
Eligibility  
 
Informed Consent ; Eligibility Criteria  
Medical History & Demographics  
X 
 
 
 
 
 
Safety Assessments    
Adverse Events; Concomitant Medications  
 
X 
X* 
X 
X 
X 
Study Intervention  
BBL /MOXI/ Halo  
 
X 
 
X 
 
 
Assessments  
Standard Photography; VISIA Imaging/Analysis  
X 
 
 
 
X 
X 
Evaluations  
Global Aesthetic Improvement Scale 
 
 
 
 
 
X 
*Visit 3 determine whether patient is candidate for second treatment.   
 

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Study Visits 
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, he 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. 
 
Visit 1: Screening (Day -45 to 0) 
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.  
 
Treatment(s): Visit 2 (First treatment), Visit 4 (Second treatment* - if indicated, see Visit 3) 
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 then 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. 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. 
2. Subjects will acclimate to ambient temperature and humidity conditions for 15 minutes prior to any 
procedures being done. 
3. A trained staff member will apply a topical triple anesthetic (benzocaine, lidocaine, tetracaine) to 
anesthetize the areas being treated. After allowing 30 minutes for the anesthetic to take effect, the skin 
will be cleansed and prepped with antiseptic. 
 
The procedure will then be performed in our Plastic Surgery clinic following standard of care procedures. A trained staff 
member will treat the subject’s face with BBL/MOXI/HALO. 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.  Post-treatment cooling will be offered at the 
discretion of the treating provider and depending on clinical availability. 
 

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After the procedure, subjects will be provided appropriate post-treatment care instructions as deemed appropriate by the 
Investigator or study staff. Subjects will be instructed that blistering, 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 after BBL/MOXI/HALO is expected to 
be 7-10 days. 
 
The treatment visit(s) is expected to take approximately 1 hour. 
 
*A subset of subjects will return for a second treatment 45-60 days after the initial treatment.  The PI and/or Sponsor will 
make a determination if a second treatment would be beneficial to the subject.  All follow up visits will be scheduled 
accordingly. 
 
PI Assessment: Visit 3 (1-month follow-up from initial treatment) 
The physician will assess the patient at their 1-month follow-up after the initial treatment. The treating 
physician will determine if a single treatment is sufficient for achieving aesthetic goals or a second treatment is 
indicated based on the patient’s presentation. Candidacy for a second treatment may involve assessment of the 
following factors: 
• 
Stage of healing 
• 
Absence of complications and adverse events 
• 
Treatment tolerance by patient 
• 
Patient interest and consent 
• 
Review of VISIA data and Photography 
 
Follow Up Visits (1M & 3M post final treatment): Visit 3 & 4 (Single tx) or Visit 5 & 6 (Double tx) 
At a minimum, all subjects will return for follow-up visits at 1 month (± 7 days) and 3 months (± 7 days) after the final 
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 then 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-range and standard photography as described in section entitled, 
“Assessments”, for research purposes.  
5. Obtain post-treatment photographs and measurements using the Vectra H2 3D Imaging System and 
VISIA Imaging System as described in section entitled, “Assessments”, for research purposes. 
 
These visits will take about 30 minutes. 
 
Assessments 
Photography Procedures 
NIKON D7200 
Standard and close-range of the face will be utilized for evaluation of pigmentation. These photographs will be taken 
utilizing the Nikon D7200 at Baseline (Screening Visit), 1-month post-treatment and 3-months post-treatment. 
 
VISIA CR 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). 

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Potential Risks 
Risks of Anesthetic 
Allergic Reaction (Rare) 
There is a possibility of an allergic or toxic reaction to anesthesia used to numb the areas. Subjects will be questioned with 
regard to any history of allergies and carefully monitored for signs of allergic reaction. 
 
Risks of Treatments 
BBL: Broad Band Light 
Erythema: (Occasionally < 3%) 
May 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. 
Swelling and/or itching: (Occasional <3%) 
May occur in the area of treatment and may last up to several hours.  The pattern of the treatment may be visible on the 
skin, but this usually fades with healing.  Itching and hive-like appearance may also occur. 
Bruising: (Rare < 1%)  
A mild bruising may occur at the treatment area as a result of laser exposure. This is usually transient and resolves in a few 
hours to few days. 
Skin roughness and/or peeling (Occasional <3%) 
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.  
 
Lasers: MOXI (Non-ablative Laser Facial Resurfacing & HALO (Fractionated Laser) 
Blistering, burning, scaling and infection:  Rare < 1%)  
A crust, blister or superficial wound can occur at the treatment area.  The risk of infection will be minimized by proper 
wound care.   
Bruising: (Rare < 1%)  
A mild bruising may occur at the treatment area as a result of laser exposure. This is usually transient and resolves in a few 
hours to few days. 
Transient edema and/or erythema: (Occasionally < 3%) 
May 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. 
 Pigmentary changes: (Rare < 1%) 
Laser exposure can cause pigmentary changes such as hyper- (3% chance) and hypo-pigmentation (<.5% chance). Although 
this is usually temporary, it may be permanent on rare occasions. Sun avoidance and/or the use of a total sun block (SPF 30 
or higher) will help minimize the intensity and duration of any pigmentary changes. 
Skin roughness and/or peeling (Occasional <3%) 
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.  
Eye injury: (Rare < 1%) 
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. 
Scarring: (Rare < 1%) 
As with any form of laser exposure, there is a small risk of scarring. However, this is minimized by proper technique and 
wound care. 
 
Risks of 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 

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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. 
 
Adverse Events 
At each visit, a member of the research team 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. 
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 BBL/MOXI/HALO 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.  
Subject Safety & Data Monitoring 
Research Standards and 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. 
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. 
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 

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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. 
Statistical 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 data obtained from VISIA Imaging Analysis results. 
A descriptive statistical summary will be provided the VISIA Imaging Analysis. 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). 
References 
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