Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03346902
Eligibility Criteria:
Inclusion Criteria:
1. Between 18 and 75 years of age, inclusive
2. Subject in good health, or with stable treated medical condition, as determined by the investigator.
3. Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be
1. Basal Cell Carcinoma
2. Squamous Cell Carcinoma (non-metastatic)
3. Other suitable lesions according to the investigator opinion
4. Lesion closure size at least 2 cm in length
5. Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)
6. Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
7. Women of childbearing potential agreeing to use either
1. a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or sterilization from the day of dosing for 3 months (subjects who underwent sterilization must have initiated the procedure at least 3 months prior to the day of dosing) or
2. dual methods of contraception with overall failures rates less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
8. Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits
9. Willing and able to sign and date IRB-approved informed consent
10. Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires
Exclusion Criteria:
1. Pregnant or breast feeding, or planning a pregnancy
2. Body weight less than 50 kg (110 pounds)
3. Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration
4. Anticipated use of any botulinum toxin of any serotype during the study
5. Known hypersensitivity to any botulinum toxin serotype
6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
7. Aminoglycoside intake within 48 hours prior to or during surgery
8. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)
9. Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk
10. Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
11. Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration
12. Any eyebrow or eyelid ptosis at baseline as determined by the Investigator
13. History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator
14. History of alcohol or drug abuse in the last 3 years, based on investigator judgement
15. User or former user of nicotine-containing products, as follows:
1. including but not limited to cigarettes, cigars, and chewing or dipping tobacco) who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 1 year before study drug administration, or
2. topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration
16. Anticipated need for surgery or overnight hospitalization during the study
17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03346902
Study Brief:
Protocol Section:
NCT03346902