H. John Visser, DPM 1, E. Dennis Harris, MD 2, Peter Hurwitz 3, Derek Dietze 4

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1 Presented at the 6th Annual Scar Club Conference (Montpellier, France) and the European Tissue Repair Society & the Wound Healing Society (Copenhagen, Denmark) Patient-Reported Outcomes and Perceptions Following the Use of Topical Compounded Scar/ Burn Creams: Interim Results from an IRB-approved Observational Study (TARGET) H. John Visser, DPM 1, E. Dennis Harris, MD 2, Peter Hurwitz 3, Derek Dietze 4 1 Mid-West Podiatry and Associates, LLC, Creve Coeur, Missouri, 2 Safe Harbor Compliance and Clinical Services, LLC, Austin, TX, 3 Clarity Research and Consulting, LLC, Narragansett, RI, 4 Metrics for Learning, LLC, Queen Creek, AZ TARGET is an ongoing IRB-approved Observational Study by Clarity Research on the effectiveness of compounded topical treatments for scar/burn characteristics, symptoms and patient perceptions.

2 Key Interim Results From Enrolled Patients (N=109): Over an average 128 days of scar/burn cream treatment use, patients reduced their usage of pain medications by 69%. The creams were safe and well-tolerated, and no serious adverse events occurred. Reductions in scar size were reported in 69% of patients, results confirmed by clinician measurements which showed a statistically significant reduction in the percentage of patients with largest (>20 mm) scars at baseline. Patients also reported reductions in itching and scar/burn interference with general activity, mood, sleep, life enjoyment and an improvement in emotional well-being with the use of the treatment compound. Introduction In addition to aesthetic implications, scar tissue can cause symptoms including pain, itching, tenderness, physical deformities, and psychological effects, and can interfere with daily activities (1). While scarring is a widespread issue impacting most individuals, there is no consensus on optimal treatment (2). Pharmaceutical compounding allows the tailoring of treatment among clinicians to individual patient needs and may present a more effective therapeutic strategy. This interim analysis of the first 109 patients enrolled into this observational, IRB-approved study involving 31 sites across the United States evaluated patient- and clinician-reported outcomes and perceptions regarding the use and effectiveness of scar/burn treatment compounds. Purpose The purpose of this observational study is to assess the effectiveness of compounded topical treatment therapies on scar attributes and patient perceptions. Methods Adult patients (ages years) with scar/burn tissue 1 month, healed, closed and not infected and using one of two formulations of compounded scar tissue treatment were enrolled: Collagenase 200U/gm, Naltrexone 1% 10mg/gm, Aloe Vera freeze dried 1:200 3mg/gm in Pracasil Plus gel Naltrexone 1% 10 mg/gm, EGCG 1%, Dimethyl Sulfone 5%, Caffeine 1% in anhydrous gel Surveys were administered at each visit, with a section for the clinician and a section for the patient to complete. Interim results collected from surveys 1 and 3 and reported. OR

3 Results Table 1. Patient Characteristic Mean + SD Female/Male (n), n=109 97/12 Range Age at Survey 1 (years), n= Race, n=110 White/Caucasian: 76 Hispanic/Latino: 20 How long had scar/burn (n), n=108 Time between Surveys 1 & 3 (days), n=110 SD= standard deviation 1 month: months: months: Black/African American: 8 Other: years: 30 > 5 years: 43 Table 2. Changes in Pain Medication Use from Survey 1 to Survey 3 Current Medication Usage Survey 1(%, n) Survey 3 (%, n) Yes 63.1, 65 *19.4, 20 None 36.9, , 83 *P <.001, a 69.3% decrease in medication use Table 3. Patient-Reported Side Effects from Scar Medication* (n=108) Side Effects %, n None 90.7, 98 Rash or redness at scar site 3.7, 4 Other (not specified) 3.7, 4 Skin Dryness 1.9, 2 *No serious adverse events were reported

Sizes at Baseline Clinician Measurements (n=93) 60 50 Survey 1

4 Figure 1. Have you noticed a reduction in the size of the scar since you started the medication? (n=109) Yes 69% No 31% Figure 2. Reduction in the Percentage of Patients with Largest Scar/Burn Sizes at Baseline Clinician Measurements (n=93) Survey 1 Survey 3 P=.003* Percent of Patients mm 6-10 mm mm >20 mm Scar/Burn Length

Figure 3. Reductions in Patient-Reported Scar/Burn Itching Over the Previous 7 Days (n=104) 5 Mean Itching Rating* 4 3 2 1 P<.001, 47% decrease in itching rating 1.7 0.

5 General Activity 2.0 1.1 Mood (n=106) Survey 1 Survey 3 *P.017 for each component and the Overall Interference Score. 50% decrease in Overall Interference Score. 1.2 1.3 0.

5 Figure 3. Reductions in Patient-Reported Scar/Burn Itching Over the Previous 7 Days (n=104) 5 Mean Itching Rating* P<.001, 47% decrease in itching rating Survey 1 Survey 3 Figure 4. Improvements in Patient-Reported Scar/Burn Interference from Survey 1 to Survey 3 Mean Interference Rating** General Activity Mood (n=106) Survey 1 Survey 3 *P.017 for each component and the Overall Interference Score. 50% decrease in Overall Interference Score Restrictions--using limbs (n=108) 0.3 Normal work Relations with other people Interference Component Sleep Enjoyment of life Overall Interference Score (n=102)

a. Rate your experience using the scar cream (n=108) Hasn't helped at all 12% Has helped with scar

Rate your emotional well-being since using the scar medication (n=108) I feel a lot better about

suggest that the compounded scar/burn creams may reduce scar/burn size, itching, mood and pain

A majority of patients believed that the compounded creams helped scar appearance and improved

Limitations This was an interim analysis.

6 a. Rate your experience using the scar cream (n=108) Hasn't helped at all 12% Has helped with scar appearance 36% Has helped slightly 52% b. Rate your emotional well-being since using the scar medication (n=108) I feel a lot better about myself 19% No change 44% A slight change 37% Conclusions Results from this interim analysis suggest that the compounded scar/burn creams may reduce scar/burn size, itching, mood and pain interference scores. A majority of patients believed that the compounded creams helped scar appearance and improved their emotional well-being. The compounded scar/burn creams were safe and well-tolerated. Limitations This was an interim analysis. A more detailed analysis will be conducted at the conclusion of the study. This is an observational survey study and thus, changes observed cannot definitely be attributed to the scar/burn creams. These preliminary, observational study results provide a good foundation for future randomized controlled trials.

References 1. Brown BC, McKenna SP, Siddhi K, McGrouther DA, Bayat A. The hidden cost of skin scars: quality of life after skin scarring. J Plast Reconstr Aesthet Surg. 2008;61(9):1049-58. 2. Reish RG, Eriksson E.

7 References 1. Brown BC, McKenna SP, Siddhi K, McGrouther DA, Bayat A. The hidden cost of skin scars: quality of life after skin scarring. J Plast Reconstr Aesthet Surg. 2008;61(9): Reish RG, Eriksson E. Scar treatments: preclinical and clinical studies. J Am Coll Surg. 2008;206(4): For a PDF of the presented TARGET Poster, please scan the QR Code For questions please contact Clarity Support at:

PracaSil -Plus. Scientific Publications. The original topical silicone base for scars and other skin conditions. Provided by

PracaSil -Plus. Scientific Publications. The original topical silicone base for scars and other skin conditions. Provided by PracaSil -Plus The original topical silicone base for scars and other skin conditions. Scientific Publications Provided by PracaSil -Plus TECHNICAL REPORT In Vitro Evaluation of the Safety Profile of PracaSil