Abstract
In addition to aesthetic implications, scar/burn tissue can cause symptoms including pain, itching, tenderness, physical deformities, and psychological effects, and interferes with daily activities. Collection of physician- and patient-reported outcomes is important in the study of scar/burn treatments. This prospective observational survey study (IRB-approved, informed consent) evaluated physician- and patient-reported outcomes for patients treated with compounded scar/burn gel over 4 and 8 months. Adult patients with scar/burn tissue ≥1-month old, healed/closed, uninfected, using one of two formulations of compounded scar tissue treatment (collagenase 200U/gm, naltrexone 1% 10mg/gm, aloe vera freeze-dried 1:200 3mg/gm, in anhydrous silicone base with pracaxi plant seed oil; OR naltrexone 1% 10mg/gm, EGCG 1%, dimethyl sulfone 5%, caffeine 1%, in anhydrous silicone base with carapa guaianensis plant seed oil) enrolled. Results (2014–2017) report paired analyses from physician/patient surveys at baseline to visit 3 (120 days, n=522, 435F/87M) and to visit 6 (240 days, n=68, 60F/8M). From baseline to visit 3: 52% (272/522) reported reduced scar size; in those with itching rating >0, ratings ↓73% (3.79 to 1.02/10, P<.001, n=130); scar interference with mood/daily activities ↓52% (0.90 to 0.43/10, P<.001, n=522); patients taking medication for pain ↓75% (43.1% to 10.9%, P<.001, n=522); adverse events reported by 4% (21/522)—none serious; 91% (473/522) indicated the creams helped/improved scar appearance. From baseline to visit 6: 74% (50/68) reported reduced scar size; in those with itching rating >0, ratings ↓88% (3.85 to 0.45/10; P<.001, n=20); scar interference with mood/daily activities ↓75% (1.22 to 0.30/10, P<.001, n=68). The compounded gel treatments used in this study may reduce: scar size, itching ratings, mood/daily living interference scores, and pain medication use, at 4 months, and more so at 8 months. The compounded gels were safe/well-tolerated. Compounded gels may provide a safe and well-tolerated treatment for reduction of: scar size, mood/daily living interference scores, and pain medication use, in adult patients with burn scars.
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