Prospective case-control trial evaluating silicone gel for the treatment of direct brow lift scars.

OBJECTIVE

To evaluate the effectiveness of a topical silicone gel on scars in patients who had undergone bilateral direct brow lift surgery.

DESIGN

A randomized double-blind clinical trial with a placebo applied to one scar and topical silicone gel (Dermatix Ultra; Valeant Pharmaceuticals, Laval, Que.) used on the other scar for 2 months.

PARTICIPANTS

Twelve patients (for a total of 24 surgical scars evaluated) were included in the study.

METHODS

This study was performed in 2 academic hospitals of the University of Montreal in Montreal, Que. (Maisonneuve-Rosemont Hospital and Notre-Dame Hospital). Inclusion criteria were all bilateral direct brow lift surgeries performed in our hospitals. Exclusion criteria included revision surgery, silicone or latex allergy, and wound infection. Each patient received 2 tubes (1 with silicone gel and 1 with placebo) and applied 1 tube to their right brow scar and the other tube to their left brow scar, following the preassigned instructions. The patient and surgeon were blinded to the nature of the substance that was applied to each scar. At each visit, pictures of both scars were taken, and a questionnaire titled "The Patient and Observer Scar Assessment Scale" was filled out by the patient and the surgeon. A grade ranging from 0 to 10 was given on the multiple criteria in the questionnaire, and the sum of these grades was subsequently used for the data analysis. A lower sum was interpreted as improved scarring. At the end of the study, an independent evaluator graded both scars based on pictures. Follow-up visits were held on day 7, week 6, month 3, and month 6 after surgery. A comparison of the experimental and placebo group was performed with nonparametric tests of Wilcoxon signed rank.

RESULTS

A total of 24 scars of 12 patients were analyzed (based on 4 follow-up visits). General improvement of scars was reported by the patient, the surgeon, and based on pictures. No statistically significant difference was found between the group treated with silicone gel and the group treated with placebo. All tests had a p value ≥0.08.

CONCLUSIONS

We did not find a statistically significant difference between scars treated with silicone gel and scars treated with the placebo after direct brow lift surgery.