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Studies on the Efficacy of Dermatix® in Scar Management

Study Patients Intervention Scar Evaluation Outcome
Controlled Comparative Study

Chan et al. [2]; prospective, randomized, double-masked, within-subject comparison study

50 Asian patients who underwent median sternotomy

Twice-daily silicone gel on half of wound compared with placebo gel on other half of wound from postoperative week 2 to month 3

Vancouver Scar Scale scores of pigmentaion, vascularity, pliability, height, pain, and itchiness

Scars that developed during silicone gel treatment were significantly flatter, less red, and more pliable and associated with significantly less pain and itching than scars that developed during placebo treatment

Signorini and Clementoni [3]; prospoective, randomized, parallel- group comparison study

160 patients who underwent surgery

Twice-daily silicone gel treatment compared with no treatment initiated from 10 days to 3 weeks after surgery for 4 months

Scar quality (normal mature, slightly hypertrophic, hypertrophic, or keloid scar based on color, hardness, elevation, and relationship to wound margins)

Scar quality was significantly better in the silicone gel group than in the no treatment group at the 6-month follow-up visit: the incidence of hypertrophic of keloid scarring was 7% in the silicone gel group compared with 26% in the no treatment group

Chernoff et al. [4]; prospoective, within- subject comparison study

30 patients with bilateral hypertrophic scars, keloids, or scars will in an erythematous and raised stage of healing

Silicone gel, SGS, or a combination of treatments for one scar compared with no treatment for the bilateral scar for 3 months

Scar elevation and skin surface texture measued using optical profilometryl erythema; pliability; severity of symptoms

Scars treated with silicone gel, SGS, or silicone gel/SGS were statistically significantly less elevated, less red, and associated with fewer sympromes than untreated scars

Fonseca Capdevilla et al. [5]; prospective, parallel-group comparison study

132 patients who underwent removal of a benign skin lesion

Silicone gel treatment compared with SGS treatments initiated within 1 month of surgery

Height; redness; pliability; itching; pain/tenderness

Silicone gel and SGS were both effective in improving scar redness, hardness, elevation, pain, and itching; there were no statistically significant differences between silicone and SGS on any efficay parameter at the month 6 follow-up

Large-scale Observational Study

Sepehrmanesh [6]; prospective, open-label, non-controlled study

1,522 patients with scars

Silicone gel was aplpied on average twice daily for 2 to 6 months, maximum 10 months

Height; color; pliability; itching; pain/tenderness

Improvement in scar color, pliability, height, itching, and pain/tenderness after silicone gel treatment of approximately 70% to 84.2% of patients

Small Case Series

Murison and James [7]; prospective, noncontrolled study

6 patients with excessive scars (most at least 2 years old)

Silicone gel used for 8 weeks

Adapted Vancouver Scar Scale scores of elevation, redness, hardness, itching, tenderness and painl collagen content and blood flow measured using intracutaneous spectrophotometry

All scars showed improvement in redness, elevation, hardness, and itching, and pain was reduced in symptomatic scars