Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis
Hyperhidrosis
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.
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
Sites / Locations
- Carl SwartlingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Palmar hyperhidrosis, Botox (onabotulinumtoxinA)
Palmar hyperhidrosis, NaCl
Plantar hyperhidrosis, Botox (onabotulinumtoxinA)
Plantar hyperhidrosis, NaCl
Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...)
Inguinal (groins/buttocks) hyperhidrosis, NaCl
Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...)
Craniofacial hyperhidrosis, NaCl
Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)
Truncal hyperhidrosis, NaCl
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Solution for injection, individual dosing, maximum dose 2500 units, single treatment session.
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Solution for injection, individual dosing, maximum dose 5000 units, single treatment session.
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.