{
    "info": {
        "nct_id": "NCT01459666",
        "official_title": "A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of AbobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer",
        "inclusion_criteria": "Patients must meet all of the following inclusion criteria to be eligible for enrollment:\n\n* Ability to understand the risks, benefits, and alternative to participation and give informed consent\n* Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).\n* Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater\n* If female, not currently pregnant, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)\n* Agrees to not use disallowed concomitant medications (retinoids)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "The presence of any of the following will exclude a patient from study enrollment.\n\n* Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period\n* Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)\n* Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents)\n* History of radiation therapy or chemotherapy\n* History of keloid or other hypertrophic scar formation\n* Current or past history of scleroderma\n* Has used botulinum toxin in the forehead area within one year.\n* Has significant resting eyebrow ptosis\n* Has used any topical retinoids to the forehead area within the past 4 weeks\n* Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries\n* Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.\n* Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate.\n* House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject.\n* The investigator feels that for any reason the subject is not eligible to participate in the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ability to understand the risks, benefits, and alternative to participation and give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand the risks, benefits, and alternative to participation",
                    "criterion": "understanding of trial information",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven skin cancer",
                    "criterion": "skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "medial forehead",
                    "criterion": "location of skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "specific location",
                            "expected_value": "medial forehead"
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to Mohs surgery",
                    "criterion": "suitability for Mohs surgery",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater",
            "criterions": [
                {
                    "exact_snippets": "Undergoing elective reconstruction",
                    "criterion": "elective reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy proven skin cancer",
                    "criterion": "biopsy proven skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to Mohs surgery",
                    "criterion": "amenability to Mohs surgery",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "defect size measuring 1.0 cm or greater",
                    "criterion": "defect size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, not currently pregnant, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)",
            "criterions": [
                {
                    "exact_snippets": "female, not currently pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no potential for pregnancy",
                    "criterion": "potential for pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "if of child-bearing age, must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A negative urine pregnancy test is required at study entry for female subjects of childbearing potential",
                    "criterion": "urine pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agrees to not use disallowed concomitant medications (retinoids)",
            "criterions": [
                {
                    "exact_snippets": "not use disallowed concomitant medications (retinoids)",
                    "criterion": "use of concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "retinoids"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "The presence of any of the following will exclude a patient from study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "The presence of any of the following will exclude a patient from study enrollment.",
                    "criterion": "exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who are breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child bearing age who are unwilling to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Current or past history of a neuromuscular disease",
                    "criterion": "neuromuscular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myasthenia gravis",
                    "criterion": "myasthenia gravis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amyotrophic lateral sclerosis",
                    "criterion": "amyotrophic lateral sclerosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eaton-Lambert syndrome",
                    "criterion": "Eaton-Lambert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents)",
            "criterions": [
                {
                    "exact_snippets": "Currently taking aminoglycosides",
                    "criterion": "aminoglycosides usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other agents interfering with neuromuscular transmission (e.g., curare-like agents)",
                    "criterion": "agents interfering with neuromuscular transmission",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of radiation therapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "History of radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of keloid or other hypertrophic scar formation",
            "criterions": [
                {
                    "exact_snippets": "History of keloid",
                    "criterion": "keloid formation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other hypertrophic scar formation",
                    "criterion": "hypertrophic scar formation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or past history of scleroderma",
            "criterions": [
                {
                    "exact_snippets": "Current or past history of scleroderma",
                    "criterion": "scleroderma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has used botulinum toxin in the forehead area within one year.",
            "criterions": [
                {
                    "exact_snippets": "Has used botulinum toxin in the forehead area within one year.",
                    "criterion": "botulinum toxin use in forehead area",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has significant resting eyebrow ptosis",
            "criterions": [
                {
                    "exact_snippets": "significant resting eyebrow ptosis",
                    "criterion": "eyebrow ptosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "state",
                            "expected_value": "resting"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has used any topical retinoids to the forehead area within the past 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Has used any topical retinoids to the forehead area within the past 4 weeks",
                    "criterion": "topical retinoids use",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "forehead area"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 4 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries",
            "criterions": [
                {
                    "exact_snippets": "Undergo any scar revision procedure",
                    "criterion": "scar revision procedure",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intralesional kenalog",
                    "criterion": "intralesional kenalog",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laser treatment",
                    "criterion": "laser treatment",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scar revision surgeries",
                    "criterion": "scar revision surgeries",
                    "requirements": [
                        {
                            "requirement_type": "undergo",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to any component of abobotulinumtoxinA",
                    "criterion": "hypersensitivity to abobotulinumtoxinA components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein)",
                    "criterion": "hypersensitivity to cow milk protein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous hypersensitivity to any botulinum toxin A or related product",
                    "criterion": "hypersensitivity to botulinum toxin A or related product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate.",
            "criterions": [
                {
                    "exact_snippets": "Non-English speaking: These patients are excluded",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "language",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject.",
            "criterions": [
                {
                    "exact_snippets": "House staff ... are not eligible",
                    "criterion": "house staff",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "students, medical students on a clerkship ... are not eligible",
                    "criterion": "students",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "employees related to study personnel ... are not eligible",
                    "criterion": "employees related to study personnel",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "employees ... who work for any study personnel ... are not eligible",
                    "criterion": "employees who work for study personnel",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "members of the study team are not eligible",
                    "criterion": "members of the study team",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The investigator feels that for any reason the subject is not eligible to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "The investigator feels that for any reason the subject is not eligible to participate in the study",
                    "criterion": "investigator's discretion",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patients must meet all of the following inclusion criteria to be eligible for enrollment:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}