OBJECTIVE: To compare the effectiveness of 1 and 2 radiofrequency (RF) treatments with the ThermaCool TC system (Thermage Inc, Hayward, Calif) on middle and lower face laxity. METHODS:Twenty patients with mild to moderate laxity of the middle and lower face were randomly assigned to receive either a single RF treatment or 2 treatments spaced 1 month apart. Treatment energy levels were titrated to patient tolerance and ranged from 85 to 135 J/cm(2). Acute clinical response was recorded after each session. Standardized photographs were taken before treatment and at 1 and 4 months after the last treatment. Using a percentage scale, 4 blinded physicians experienced in dermatologic laser therapy independently rated improvement in nasolabial folds, marionette lines, jowls, laxity under the chin, and overall appearance. In addition, subjects completed quality-of-life surveys 1 and 4 months after treatment. Each patient paid the same fee for involvement in the study. RESULTS: Eleven patients received a single RF treatment, and 9 patients underwent 2 treatments. All subjects experienced mild edema and mild to moderate erythema as an acute clinical response; no patients experienced burns, skin breakdown, or scarring. At 4-month follow-up, patients in the 2-treatment group received higher scores in all categories of photographic analysis; the difference in improvement in the nasolabial folds was statistically significant (P = .04). In self-assessment ratings, individuals receiving 2 treatments reported more improvement than subjects in the single-treatment group 4 months after treatment (P = .03). In both treatment groups, physician photographic assessment demonstrated continued improvement in all subsites between the 1-month and 4-month assessments (P<.05). Although the overall change noted by both patients and physicians was modest in most patients, 75% of subjects (n = 15) stated they would consider paying for additional treatments. CONCLUSIONS: Two RF treatments yielded significantly better improvement than a single treatment in the nasolabial folds. Significant improvement in laxity after treatment was seen between the 1- and 4-month follow-up visits in both single- and 2-treatment groups. Although overall improvements were modest in both groups, patient satisfaction was relatively high.
RCT Entities:
OBJECTIVE: To compare the effectiveness of 1 and 2 radiofrequency (RF) treatments with the ThermaCool TC system (Thermage Inc, Hayward, Calif) on middle and lower face laxity. METHODS: Twenty patients with mild to moderate laxity of the middle and lower face were randomly assigned to receive either a single RF treatment or 2 treatments spaced 1 month apart. Treatment energy levels were titrated to patient tolerance and ranged from 85 to 135 J/cm(2). Acute clinical response was recorded after each session. Standardized photographs were taken before treatment and at 1 and 4 months after the last treatment. Using a percentage scale, 4 blinded physicians experienced in dermatologic laser therapy independently rated improvement in nasolabial folds, marionette lines, jowls, laxity under the chin, and overall appearance. In addition, subjects completed quality-of-life surveys 1 and 4 months after treatment. Each patient paid the same fee for involvement in the study. RESULTS: Eleven patients received a single RF treatment, and 9 patients underwent 2 treatments. All subjects experienced mild edema and mild to moderate erythema as an acute clinical response; no patients experienced burns, skin breakdown, or scarring. At 4-month follow-up, patients in the 2-treatment group received higher scores in all categories of photographic analysis; the difference in improvement in the nasolabial folds was statistically significant (P = .04). In self-assessment ratings, individuals receiving 2 treatments reported more improvement than subjects in the single-treatment group 4 months after treatment (P = .03). In both treatment groups, physician photographic assessment demonstrated continued improvement in all subsites between the 1-month and 4-month assessments (P<.05). Although the overall change noted by both patients and physicians was modest in most patients, 75% of subjects (n = 15) stated they would consider paying for additional treatments. CONCLUSIONS: Two RF treatments yielded significantly better improvement than a single treatment in the nasolabial folds. Significant improvement in laxity after treatment was seen between the 1- and 4-month follow-up visits in both single- and 2-treatment groups. Although overall improvements were modest in both groups, patient satisfaction was relatively high.