Proven Efficacy
"Silicone gel dispensed from a tube has significant benefits in ease of use, but different formulations of silicone gel may vary in efficacy."[1]
Studies on the Efficacy of Dermatix® in Scar Management
| Study |
Patients |
Intervention |
Scar evaluation |
Outcome |
| Controlled comparative studies |
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 pigmentation, 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 Clementonil[3];
prospective, 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 or keloid scarring was 7% in the silicone gel group compared with 26% in the no treatment group |
Chernoff et al. [4];
prospective, within-subject comparison study |
30 patients with bilateral hypertrophic scars, keloids, or scars still 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 measured using optical profilometry; 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 symptoms than untreated scars |
Fonseca Capdevila et al. [5];
prospective, parallel-group comparison study |
132 patients who underwent removal of a benign skin lesion |
Silicone gel treatment compared with SGS treatment 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 efficacy 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 applied 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 pain; 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 |
|
References:
- Mustoe TA. 21st World Congress of Dermatology, 2007
- Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M (2005) A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg 116:1013-1020
- Signorini M, Clementonil MT (2007) Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. Aesth Plast Surg 31:183-187
- Chernoff WG, Cramer H, Su-Huang S The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and postlaser exfoliation erythema. Aesth Plast Surg, doi:10.1007/s00266-006-0218-1
- Mustoe TA. Aesth Plast Surgery 2008; 32(1): 82-92
- Sepehrmanesh M (2006) Observational study of 1,522 patients using Dermatix gel.
Kompendium Dermatologie 1:30–32
- Murison M. James WJ Plast Reconstr Aesth Surg 2006. 59: 437-439
|