The Effects of Fractional CO2 Laser on Poikiloderma of Civatte
Phase: NA
Conditions: Poikiloderma of Civatte
Sponsor: University of Texas Southwestern Medical Center

Official title: The effects of fractional CO2 laser on Poikiloderma of 
Civatte 
 
NCT number: NCT04581330 
IRB Approved date: 09-09-2020 

STU2020-0827, Goff, FormA-ResearchProtocol, NS, 09-09-20 (3) 
 
The University of Texas Southwestern Medical Center at Dallas 
Institutional Review Board 
 
Protocol Template (for Investigator Initiated Studies)  
 
Title: The effects of fractional CO2 laser on Poikiloderma of Civatte 
Principal investigator: Heather W. Goff, M.D. 
Funding Sponsor: UTSW Dept of Dermatology 
IND Number (if applicable): 
Version number and date: Version 1; 7/19/2020 
 
Introduction and Purpose: This study will assess the safety and efficacy of fractional CO2 
laser treatment for Poikiloderma of Civatte (POC). POC is a chronic vascular and pigmentary 
disorder typically involving the lateral and inferior neck region, as well as the chest area. 
Clinically, poikiloderma appears as a combination of telangiectasia, irregular pigmentation, and 
atrophic changes1.  Previously studied effective treatments of POC include pulsed dye lasers and 
IPL devices.2,3,4,5 Ineffective treatments include hydroquinone, electrosurgery, argon laser 
photocoagulation, and cryotherapy.6 Although PDL and IPL laser technologies are relatively 
safe, there have been a few reports of PDL treatment with subsequent complications, which may 
include ulceration developing immediately after treatment as well as scarring.7,8,9,10Additionally, 
 
1 Arielle NB Kauvar MD, Agneta Troilius MD PhD, Chapter 39. Laser and Light Treatment of Acquired and 
Congenital Vascular Lesions. Surgery of the Skin, 2005 Pages 625-644. Available online 18 September 2013. 
2 Haywood RM, Monk BE. Treatment of poikiloderma of Civatte with the pulsed dye laser: a series of seven cases. J 
Cutan Laser Ther. 1999;1(1):45-48. doi:10.1080/14628839950517093 
3 Clark RE, Jimenez-Acosta F. Poikiloderma of Civatte. Resolution after treatment with the pulsed dye laser. N C 
Med J. 1994;55(6):234-235. 
4 Goldman MP, Weiss RA. Treatment of poikiloderma of Civatte on the neck with an intense pulsed light source. 
Plast Reconstr Surg. 2001 May;107(6):1376-81. PubMed PMID: 11335804. 
5 Wheeland RG, Applebaum J. Flashlamp-pumped pulsed dye laser therapy for poikiloderma of Civatte. J Dermatol 
Surg Oncol. 1990 Jan;16(1):12-6. PubMed PMID: 2299018. 
6 Geronemus R. Poikiloderma of Civatte. Arch Dermatol. 1990;126(4):547–548. 
doi:10.1001/archderm.1990.01670280133038 
7 Levine VJ, Geronemus RG. Adverse effects associated with the 577- and 585-nanometer pulsed dye laser in the 
treatment of cutaneous vascular lesions: a study of 500 patients. J Am Acad Dermatol. 1995;32:613-617. 
8 Witman PM, Wagner AM, Scherer K, et al. Complications following pulsed dye laser treatment of superficial 
hemangiomas. Lasers Surg Med. 2006;38:116-123. 
9 Sommer S, Sheehan-Dare RA. Atrophie blanche-like scarring after pulsed dye laser treatment. J Am Acad 
Dermatol. 1999;41:100-102. 
10 Navid Ezra, MD; Daniel Behroozan, MD. Linear Scarring Following Treatment With a 595-nm Pulsed Dye Laser. 
Cutis. 2014 August;94(2):83-85 

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PDL and IPL laser treatments require multiple sessions before seeing a clinically significant 
effect and do not address textural issues.11 Therefore, alternative safe and effective options for 
management of POC are still needed. Fractional CO2 laser has been widely used for photoaging 
due to its effectiveness and high safety profile.12,13 Clinically evident improvement can be 
appreciated even after only one session of treatment.13 
One previous study showed that ablative fractional laser resurfacing was both safe and effective 
for the treatment of the vascular, pigmentary and textural components of POC.14  Little data exist 
regarding the use of fractional CO2 laser for management of POC. This study hopes to fulfill this 
purpose.  
2. Background 
Poikiloderma of Civatte (POC) is characterized by vascular and pigmented lesions consisting of 
linear telangiectasias, mottled dyspigmentation and superficial atrophy in a reticular pattern 
found on sun-exposed areas of the face and neck, often sparing the shaded, submental area.15,16 
Fair-skinned women in their 4th and 7th decades of life are predominantly affected.15  Most 
cases are benign and asymptomatic, however, some report symptoms of pruritus, burning 
sensation and flushing triggered by sun exposure.15 The cosmetically unappealing lesions can be 
distressing to affected individuals. The cause of POC is multifactorial. Chronic sun exposure, 
 
11 Hruza, George. Lasers and Lights: Procedures in Cosmetic Dermatology Series. Elsevier, 2018. 
12 Tierney EP, Hanke CW. Fractionated carbon dioxide laser treatment of photoaging: prospective study in 45 
patients and review of the literature. Dermatol Surg. 2011;37(9):1279-1290. doi:10.1111/j.1524-4725.2011.02082.x 
13 Tierney EP, Hanke CW. Ablative fractionated CO2, laser resurfacing for the neck: prospective study and review 
of the literature. J Drugs Dermatol. 2009;8(8):723-731. 
14 Tierney EP, Hanke CW. Treatment of Poikiloderma of Civatte with ablative fractional laser resurfacing: 
prospective study and review of the literature. J Drugs Dermatol. 2009;8(6):527-534. 
15 Katoulis, A.C., et al., Poikiloderma of Civatte: a clinical and epidemiological study. J Eur Acad Dermatol 
Venereol, 2005. 19(4): p. 444-8. 
 
16 Errichetti, E. and G. Stinco, Dermoscopy in Facilitating the Recognition of Poikiloderma of Civatte. Dermatol 
Surg, 2018. 44(3): p. 446-447. 

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photoallergy, and contact dermatitis to perfumes and cosmetics are implicated.15,17 While the 
disease has a chronic and unrelenting course, effective treatments have not been fully 
established. The goal of treatment is to target both the vascular and pigmented lesions to improve 
symptoms and appearances. Current treatments that yield satisfying results include pulse dye 
laser, fractional non-ablative photothermolysis, and intense pulsed light.15, 18,19,20,21,22 However, 
these therapies may induce crusting, purpura, blisters, hypopigmentation and postinflammatory 
hyperpigmentation. 18, 20,21,23,24 Multiple sessions are often needed to achieve desired cosmetic 
results.  
Carbon dioxide laser was introduced for skin resurfacing in the mid-1990s. It has a wavelength 
of 10,600 nm, has an absorbing chromophore of water, and is used to vaporize tissue. It was 
initially used as a full-field laser resurfacing device which removes the entire skin surface in the 
area being treated. In 2004, Manstein et al. introduced the concept of fractional photothermolysis 
in which only small fraction of the skin would be treated at each session, leaving skip areas in 
between.25 For the traditional full field laser resurfacing, healing occurs from deeper structures 
alone; however, fractionated laser resurfacing has the advantage of healing from deeper 
 
17 Katoulis, A.C., et al., Evaluation of the role of contact sensitization and photosensitivity in the pathogenesis of 
poikiloderma of Civatte. Br J Dermatol, 2002. 147(3): p. 493-7. 
18 Rusciani, A., et al., Treatment of poikiloderma of Civatte using intense pulsed light source: 7 years of experience. 
Dermatol Surg, 2008. 34(3): p. 314-9; discussion 319. 
19 Bernstein, E.F., et al., Treatment of poikiloderma of Civatte using a redesigned pulsed dye laser with a 15 mm 
diameter treatment spot. Lasers Surg Med, 2019. 51(1): p. 54-58. 
20 Meijs, M.M., F.A. Blok, and M.A. de Rie, Treatment of poikiloderma of Civatte with the pulsed dye laser: a series 
of patients with severe depigmentation. J Eur Acad Dermatol Venereol, 2006. 20(10): p. 1248-51. 
21 Behroozan, D.S., et al., Fractional photothermolysis for treatment of poikiloderma of civatte. Dermatol Surg, 
2006. 32(2): p. 298-301. 
22 de Medeiros, L.M., A.R. de Luzuriaga, and R. Tung, Treatment of Poikiloderma with Chemical Peeling, in Body 
Rejuvenation, M. Alam and M. Pongprutthipan, Editors. 2010, Springer New York: New York, NY. p. 39-45. 
23 Weiss, R.A., M.P. Goldman, and M.A. Weiss, Treatment of poikiloderma of Civatte with an intense pulsed light 
source. Dermatol Surg, 2000. 26(9): p. 823-7; discussion 828. 
24 Wat, H., et al., Application of intense pulsed light in the treatment of dermatologic disease: a systematic review. 
Dermatol Surg, 2014. 40(4): p. 359-77. 
25 Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for 
cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-438. 
doi:10.1002/lsm.20048 

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structures as well as adjacent untreated structures.26 This approach avoids open wound as well as 
lowers risk of pigment disturbance or scarring.11 Non-ablative fractional devices such as the 
1,550 nm wavelength Erbium fiber laser was used for treatment of POC which showed some 
clinical improvement in the degree of erythema, dyschromia, and overall texture of the neck with 
very little adverse effects.21 Fractional ablative resurfacing with carbon dioxide intends to 
provide more significant results than non-ablative systems, while achieving shorter healing times 
and complications when compared with full-field ablative systems. While fractional CO2 laser 
has been used for successful management of acne scars, facial skin rejuvenation, benign nevus, 
seborrheic keratosis, syringoma, xanthelasma, recalcitrant warts, its efficacy has not been widely 
proven for management of POC.27 This study hopes to fill that knowledge gap in order to best 
optimize treatments for future patients. 
3. Concise summary of project 
 
The study subjects’ neck and décolletage area will be divided into two equal halves. The line of 
division will be from the mid mental protuberance to manubriosternal junction. One half of the 
neck and upper chest area will be treated with ablative fractional CO2 laser while the other half 
will be untreated and used as a control. If desired after the study endpoint, patients may have the 
other side of their neck treated at no additional charge. 
Primary Outcome Measures: 
Physician's Global Aesthetic Improvement Scale at 12- and 24-weeks post treatment. 
Photographs will be presented to a panel of independent dermatologists. The panel will be 
blinded to treatment parameters and the treatment laterality at each photograph time point. Each 
 
26 Ramsdell WM. Fractional carbon dioxide laser resurfacing. Semin Plast Surg. 2012;26(3):125-130. doi:10.1055/s-
0032-1329414 
27 Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 
2014;23(1):49-60. doi:10.5978/islsm.14-RE-01 

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dermatologist will be asked to identify the baseline and post-treatment images from randomized, 
paired images for all subjects. Reviewers will rate improvement in POC in 10% increments on a 
10-point scale (0% no improvement to 100% or complete clearance)  
Secondary Outcome Measures 
Subject Satisfaction Assessment at 12- and 24-weeks post treatment.  Subjects will assess overall 
satisfaction with improvement of poikiloderma of civatte using an 5-point satisfaction and 
aesthetic scale. 
Study subjects will be followed for 24 weeks post-laser treatment to assess incidence and 
severity of all procedure-related adverse events. 
4. Study procedures 
 
Patients with a clinical diagnosis of POC defined by a skin change with atrophy, 
hypopigmentation, hyperpigmentation, dilation of the fine blood vessels (telangiectasia) will be 
recruited. Ten patients will be consented. Before the initial visit, all patients will complete a one-
month preoperative daily use of SPF 50+ sunscreen.  The sun protection is to reduce further sun 
damage and protect skin from increased photosensitivity that may occur after laser resurfacing. 
At the initial visit, high resolution photographs of the affected area on the neck and décolletage 
area will be taken. All patients will fill out a form with demographic information. Patients will be 
instructed to come to their appointment with clean skin and without any lotions or moisturizers 
on the neck or décolletage area. Laser-specific eyewear will be provided to practitioners, 
patients, and all other people in the treatment room. A blue skin marking pen will be used to 
draw a line from mid mental protuberance to manubriosternal junction to divide tested area into 
two equal halves. Compounded benzocaine, lidocaine, and tetracaine (BLT) cream in a 20:8:4% 
concentration will be applied to the treatment area for 40 minutes prior to the procedure. Before 

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the treatment, topical anesthesia will be thoroughly washed off with chlorhexidine gluconate and 
distilled water. One pass with a 1-mm spot density and a 60micron depth will be performed 
followed by a 1mm spot density and a 200-micron depth will be used.  The other half of the 
testing area will be left intact and used as the control for easy comparison. The side that 
undergoes treatment will be selected randomly. Forced cold air (Zimmer cooler) will also be 
used in conjunction with the laser device for better patient comfort.  
Cold compresses with refrigerated distilled water can be used to reduce swelling and to soothe 
the skin with frequent reapplication of white petrolatum to keep the skin coated for days 1-5 
post-procedure with strict sun avoidance for the first week post-procedure. Daily use of broad-
spectrum sunscreen with SPF50+ will be required after the first week.  
Given the current pandemic, limited in-person follow-ups will be scheduled (once at baseline 
before treatment, then at 12 and 24-weeks post-treatment. Participants will communicate 
immediate post-treatment issues or concerns along with selfies through MyChart on day 2, 3, 7, 
10, 14 to track progress and to identify any post procedural complications in a timely fashion. 
There will also be no costs to the patients for the laser procedures as funding will be supplied by 
the UT Southwestern Dermatology department via an educational grant.  Patients desiring 
treatment of the control side after the study end-point (24 weeks) will be provided at no cost for 
the participants.  
 
5. Sub-Study Procedures: N/A 
 
6. Criteria for Inclusion of Subjects 
• Male and female subjects, English and non-English speakers, and subjects more than 18 
years old 
• Clinical diagnosis of poikiloderma of Civatte affecting the neck and chest 

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• Agree to not undergo any other procedures on the neck and chest area during the study 
• Agree to refrain from tanning for 6 months post-procedure 
• Willing and able to read, understand, and sign the consent form 
• Willing and able to adhere to the treatment and follow-up schedule as well as post-
treatment care  
7. Criteria for Exclusion of Subjects 
• Patients under 18 years old 
• Active skin infection, dermatitis, or a rash on the treatment area 
• Pregnant or lactating patients 
• Patients on immunosuppressive medications 
• Any laser procedures or chemical peel procedures on the neck or chest area within the 
past 6 months 
• Patients with multiple comorbidities such as diabetes mellitus, cardiovascular diseases, 
neurologic disorders, internal malignancies 
• Personal history or family history of forming keloids or hypertrophic scars, or abnormal 
wound healing 
• Patients with known bleeding disorders or taking more than one anticoagulation 
medications  
• Undergoing any surgery in the treatment area within the past 12 months  
• History of radiation to the head, neck, and chest area 
• Systemic use of isotretinoin within 6 months 
• Any use of gold therapy 
• Current smoker or history of smoking within 12 months of study 

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• Any physical or mental condition in which the investigators deem unsafe for the subject 
to participate in the study. 
• History of recurrent herpes simplex on the neck or chest. 
 
8. Sources of Research Material 
 
Sources of materials used during this study will include data collected from patient surveys, data 
collected from blinded dermatologists’ assessment, and pictures taken of the participants. These 
materials and data will be obtained at each patient visit. Given the current pandemic, only limited 
in-person follow-ups will be scheduled (once at baseline before treatment, then at 12 weeks, 24 
weeks). Participants will communicate immediate post-treatment issues or concerns along with 
selfies through MyChart on day 2, 3, 7, 10, 14 to track progress and to identify any post 
procedural complications in a timely fashion. Materials and data gathered will be obtained 
specifically for research purposes, and no existing records or specimens will be used. 
 
9. Recruitment Methods and Consenting Process 
 
Subjects will be identified from patients presenting to the dermatology department at UT 
Southwestern. When a patient with POC is identified, they will be offered inclusion in the study. 
Informed consent will be obtained. Both English and non-English speaking patients will be 
included. If the patient is non-English speaking, a certified translator will be used to obtain 
consent. Each patient will be informed that he or she has the right to withdraw consent and 
terminate participation in the study at any point if he or she so desires. No vulnerable populations 
(cognitively impaired, institutionalized, children) will be included in the study to minimize the 
risk of undue influence or coercion. 
 
10. Potential Risks: 

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• Ocular – severe ocular complications such as corneal ulceration and cataract could 
happen with any laser devices. Therefore, CO2 laser specific eyewear will be provided to 
everyone in the treatment room. Ocular complication for this study should be low since 
we are mainly targeting the neck and upper chest area instead of the facial area.   
• Pain – Topical anesthesia, and a forced-air cooling device will be used to help patients 
tolerate the procedure. Prolonged severe pain postoperatively may indicate other 
complications such as infection infection and patient should contact the investigators and 
will be examined in-person to determine the cause. 
• Infection – patients will be counseled on signs of infection such as increased erythema, 
purulence, oozing and crusting. Patients will submit electronic selfies of the treatment 
area electronically to investigators on day 2, 3, 5, 7 and 10.  Investigators will contact 
patients if any signs of infection are identified. For patients with skin infection within the 
past 6 months, topical mupirocin ointment TID applied to the nares will be prescribed to 
prevent staph colonization.  
• Post-inflammatory hyperpigmentation: This usually happen less frequently in lighter skin 
types which are the groups most commonly affected by POC.  However, should this 
occur, hydroquinone and topical retinoids can be prescribed for the patient at the study 
end-point to alleviate the dyschromia. 
• Prolonged erythema: if erythema lasts more than 3 weeks postoperatively, a mid-potency 
topical steroid will be prescribed to the patient.  
• Scarring: patients with personal and family history of keloid disease and hypertrophic 
scar formation will be excluded from the study. If hypertrophic or keloidal scars happen, 
intralesional steroids will be used to flatten the scars.  

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11. Subject Safety and Data Monitoring   
 
All treatments will be completed at the Dermatology clinics at UT Southwestern where there are 
adequate resources for medical intervention in case of an adverse event such as increased 
bleeding, pain, or infection. The risk of severe bleeding is minimal and does not warrant the need 
for spare blood products or type and screening. 
12. Procedures to Maintain Confidentiality 
The study materials will not be disclosed to any outside persons or entities. Patient surveys 
collected will be stored securely in files in the dermatology offices and will not be removed from 
campus. 
13. Potential Benefits 
• Improved overall dyschromia and telangiectasia of the chest and neck area 
• Overall increased patient satisfaction and quality of life 
• Provide patients safe and effective alternative for treatment of discoloration and atrophy 
of neck and chest area which hopefully can be generalized to similar patient populations. 
 
14. Biostatistics 
Descriptive statistics will be used to summarize patient demographics. Count (%) will be used 
for categorical variables; and mean, standard deviation (SD), and range (min/max) will be used 
to summarize continuous variables with approximately normal distributions. Skewed continuous 
variables will be summarized by median and interquartile range (IQR). Outcome data will be 
collected on patient satisfaction assessment scores and physician’s global aesthetic improvement 
scores, as well as assessment of adverse events. The Wilcoxon signed rank test will be used to 
compare the magnitude of change between the baseline scores and post-intervention scores. The 
Wilcoxon signed rank test will also be used to compare the magnitude of change of the treated 

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area and the control area.   A p-score of <0.05 will be considered statistically significant. The 
target sample size is 10 people. 
Outcome Measurement: 
 
Global Aesthetic Improvement Scale` 
 
 
 
Patient Satisfaction Assessment