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:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT01930604
Eligibility Criteria:
Inclusion Criteria:
* Informed consent received from patient
* Informed consent received from patient´s parents (when patient \< 18 years)
* Hyperhidrosis of the head, trunk, groins/buttocks, hands or feet
* Age \> 16 years
* Patients must be previously untreated with Btx A/B
* If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom\*) throughout the study. If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the study duration of the study, for both female and male, acceptable birth control must be used for at least 3 months after the last dose of study medication.
\* A condom alone is not considered an acceptable method for birth control. Two barrier methods only are not considered an acceptable method of birth control.
* Patients must have DLQI-score ≥ 10 and HDSS-score ≥ 3
Exclusion Criteria:
* Contraindication to Btx
* Use of aminoglycosides, tetracyclines , spectinomycin, lincomycin, polymyxin or muscle relaxants
* Pregnancy or lactation
* Patients unwilling to meet the requirements of the protocol
* Other medical or social reasons for exclusion at the discretion of the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01930604
Study Brief:
Protocol Section:
NCT01930604