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Anti-CTGF Oligonucleotide Reduces Severity of Postsurgical Hypertrophic Scars in a Randomized, Double-Blind,
Jeff Jensen1, Gary Gentzkow1, Gabe Berman1
1From Excaliard Pharmaceuticals; PRA International-KCI; the Jewell Plastic Surgery Center; Connall Cosmetic Surgery; Miller Cosmetic Surgery at Scripps Hospital; the Division of Plastic Surgery, Northwestern University; and Body Aesthetic Plastic Surgery.
Background:
Connective tissue growth factor (CTGF) levels are up-regulated in wounded skin and are thought to play a major role in scar formation. An antisense oligonucleotide targeting CTGF was evaluated in adult patients undergoing hypertrophic scar revision surgery, to determine effects on reducing the severity of subsequent scars.
Methods:
In a randomized, double-blind, within-subject, placebo-controlled study, 23 female subjects (aged 28 to 55 years) with bilateral, symmetric, hypertrophic surgical scars of the breast underwent scar revision surgery. The resulting breast incisions were randomized to receive EXC 001 (5 mg/cm) or placebo injected intradermally at postsurgery weeks 2, 5, 8, and 11. Scar severity assessments were performed at weeks 12 and 24 by an expert panel using blinded photographs, and by physicians and subjects using a scar scoring scale, the Patient and Observer Scar Assessment Scale. An assumption of the design is that within-subject variance would be small and that whatever within-subject variance there was would be controlled through the randomization process.
Results:
EXC 001 significantly reduced scar severity at both 12 and 24 weeks after scar revision surgery in all three measures (expert panel and physician Patient and Observer Scar Assessment Scale, p < 0.001; Patient and Observer Scar Assessment Scale, p < 0.003).
Conclusions:
This study provided positive preliminary data that intradermal injection of EXC 001 produced a significant reduction in severity of postsurgical skin scars, as measured by physicians, subjects, and an expert panel. This study provided evidence that suppression of CTGF could be a viable strategy for hypertrophic scar reduction therapy and that further study of the antisense oligonucleotide EXC 001 was indicated.
Clinical Question/Level Of Evidence:
Therapeutic, II.
Insights
An antisense oligonucleotide targeting connective tissue growth factor (CTGF) significantly reduced hypertrophic scar severity after surgery. This therapy shows promise for improving scar reduction and future treatment strategies.
Area of Science:
- Dermatology
- Wound Healing
- Molecular Biology
Background:
- Connective tissue growth factor (CTGF) is upregulated in wounded skin, contributing significantly to scar formation.
- Hypertrophic scars are a common concern following surgical procedures.
Purpose of the Study:
- To evaluate the efficacy of an antisense oligonucleotide targeting CTGF (EXC 001) in reducing the severity of subsequent hypertrophic scars.
- To assess the potential of CTGF suppression as a therapeutic strategy for scar reduction.
Main Methods:
- A randomized, double-blind, within-subject, placebo-controlled study involving 23 female subjects with bilateral hypertrophic breast scars.
- EXC 001 or placebo was administered via intradermal injection at weeks 2, 5, 8, and 11 post-surgery.
- Scar severity was assessed at 12 and 24 weeks using blinded expert panel evaluation of photographs and the Patient and Observer Scar Assessment Scale.
Main Results:
- EXC 001 demonstrated a statistically significant reduction in scar severity at both 12 and 24 weeks.
- The reduction was consistent across all assessment measures, including expert panel, physician, and subject evaluations (p < 0.001 and p < 0.003).
Conclusions:
- Intradermal injection of EXC 001 significantly reduced the severity of postsurgical hypertrophic scars.
- Suppression of CTGF is a viable therapeutic strategy for hypertrophic scar reduction, warranting further investigation of EXC 001.
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