A Phase 3 interventional study of Botulinum toxin type A and Placebo in Scar and Intercanthal Distance Ratio, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-27.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Prevention
Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50% Asia population, giving the illusion of a shorter palpebral fissure length and a wider intercanthal distance. Currently, various epicanthoplasty techniques have been well described to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease, recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional denervation of striated muscle for 2 to 6 months after injection. Recently, experimental study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts derived from hypertrophic scars and influenced the expression of transforming growth factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth, and reduce collagen production. The main aim of this trail is to evaluate the efficiency of BTX-A injection on improving hypertrophic scaring after epicanthoplasty.
Exclusion Criteria:
5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus
Drug: Botulinum toxin type A
0.1 mL normal saline, administered in the other intercanthus
Drug: Placebo
5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection
0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection
Vancouver Scar scale
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U
Time frame: 6 month
intercanthal distance ratio
the ratio of the intercanthal distance to the interpupillary distance
Time frame: 6 month
Photographic measurement
The scar width of the patient's picture at 6 month after surgery will be measured using photoshop CS3 extended. One ruler will be placed on the patient's nose before taken the photo. Then the scar width could be measured.
Time frame: 6 month
Plan to share: No
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Shanghai Jiao Tong University School of Medicine