Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD (NCT05129319) | Clinical Trial Compass
CompletedEarly Phase 1
Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD
United States30 participantsStarted 2021-12-16
Plain-language summary
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Jeuveau in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* At least 18 years of age at the time of signing the informed consent.
* Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs).
* Subjects have moderate or severe dynamic glabellar lines on maximum frown as assessed with the Evolus GLS with photonumeric guide.
* Female sex.
* Female subjects willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A female subject is eligible to participate if she is not pregnant (has a negative urine pregnancy result at Day 1 prior to treatment), is not breastfeeding, and at least one of the following conditions applies: 1)Not a female of childbearing potential OR 2) A female of childbearing potential who agrees to follow the contraceptive guidance in Appendix 4 during the study.
* Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Written informed consent from the subject has been obtained prior to any study-related procedures.
* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information)
* Able, as assessed by the blinded evaluating investigator, and willing to follow study instructions and likely …