JP-2021506985-A5 -

Dates

Publication Date

20230523

Application Date

20181219

Description

In another embodiment, a method is provided for reducing scar tissue formation in order to improve the appearance of a scar. The method comprises administering a formulation containing botulinum toxin type E in an amount effective in reducing dynamic tension in the wound and/or paralyzing muscles near the wound, near the wound. In one embodiment, administration of BoNT/E reduces scar tissue formation in the wound compared to a similar wound that was not treated or was treated with botulinum toxin type A (BoNT/A). In one embodiment, the wound is created to remove basal cell carcinoma or squamous cell carcinoma in the subject. In another embodiment, the wound is created during a Mohs procedure. In yet another embodiment, the wound is on the face. In other embodiments, the wound is around the eyes, on the forehead, above the nose, on the scalp, or around the ears. In yet another embodiment, the wound is a single wound on the forehead. In other embodiments, the formulation or composition containing BoNT/E is administered intramuscularly. In one embodiment, the formulation is administered after the Mohs procedure. In another embodiment, the formulation is administered before the Mohs procedure. In another embodiment, the formulation is administered approximately 10 minutes to 1 hour after the Mohs procedure. In other embodiments, the appearance of the scar is assessed by a clinician using a Visual Analog Scale (VAS). In yet another embodiment, the appearance of the scar is assessed by the subject using a Scar Cosmetics Assessment and Rating Scale (SCARS). In yet another embodiment, the appearance of the scar is assessed by the subject using a Patient and Observer Scar Assessment Scale. In another embodiment, a method for improving the appearance of a scar is provided. This method comprises the step of administering a formulation containing botulinum toxin type E in an amount effective to reduce redness, reduce stiffness and/or reduce scar discoloration near the wound, wherein the reduction in redness, stiffness and/or discoloration is observed during the first 48 hours, 72 hours, 1 week or 1 month of wound healing. In one embodiment, these reductions are assessed by the patient and/or an observer, e.g., a clinician, and are relative to a similar wound that has not been treated with botulinum toxin type A (BoNT/A) or has been treated with it. In another embodiment, a method is provided for reducing scar tissue formation in a wound. This method comprises the step of subcutaneously administering a formulation containing botulinum toxin type E near the wound, thereby reducing scar tissue formation in the wound compared to a similar wound that was not treated or was treated with botulinum toxin type A. In one embodiment, the wound is perpendicular to the skin tension line of the relaxed skin. In one embodiment, botulinum toxin type E is administered in an effective amount to reduce the dynamic tension on the wound. In another embodiment, the wound is a surgical incision. In yet another embodiment, a method is provided for improving the appearance of scars formed on a wound. This method includes the step of administering a therapeutically effective dose of botulinum toxin subtype E (BoNT/E) near the wound. In one embodiment, the wound is a surgical wound. In another embodiment, BoNT/E is administered before the surgical procedure. In yet another embodiment, BoNT/E is administered after the surgical procedure. In one embodiment, the surgical wound overlaps with an existing scar in the subject. In subjects treated with BoNT/E, reduced itching and pain associated with scarring during the acute scar formation phase of wound healing, which begins after wound formation, were reported up to approximately 21, 25, or 30 days after wound formation. Therefore, in one embodiment, a method to minimize scar formation and improve the appearance of scars during wound healing is performed simultaneously with a method to reduce itching and/or pain associated with scarring. That is, treatment of the wound or the underlying muscle with BoNT/E results in improved scar appearance and reduces itching or pain associated with scar formation (or wound healing). In one embodiment, administration of BoNT/E reduces the sensation of itching associated with scarring for 24 to 48 hours in 75% or more of patients receiving BoNT/E treatment. In another embodiment, administration of BoNT/E reduces pain in at least about 25% or 50% of patients receiving BoNT/E treatment, 2 to 8 days or 1 week after wound formation and during wound healing. Photographs of surgical wounds were taken on day 1 before surgery, on day 2 (24 hours after surgery), and on days 30 and 90 of this study. The photographs (not shown herein) clearly show that subjects treated with BoNT/E had less scar redness on days 30 and 90 compared to subjects not treated with BoNT/E. Therefore, in one embodiment, a method for minimizing wound scarring is provided by administering botulinum toxin