An Open Label Study for Palmar Hyperhydrosis

• Status: Completed
• Trial end date: 2021-05-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pariser, Robert J., M.D.
• Collaborator: Virginia Clinical Research, Inc.
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for study participation.

1. Subjects must provide fully executed informed e-consent and e-assent (if applicable) prior to any study procedures.

2. Age ≥ 9 years.

3. Willing to comply with the protocol, including completion of designated virtual study visits and prescribed study treatment regimens.

4. Subjects must have access to and the ability and willingness to use their own smart device (e.g., phone, computer, tablet). Subjects must have reliable internet access and video capabilities to conduct virtual visits, e-consent, and ePROs. Subjects must have an active email address that is password protected. Their password must remain confidential throughout the study.

5. Subjects must have a street address to which study drug can be delivered and received in a timely manner. (PO Boxes will not be allowed.)

6. Male or non-lactating and non-pregnant females (documentation of a negative urine pregnancy test done by the subject must be done prior to sending study drug.)

7. Primary palmar hyperhidrosis for at least 6 months.

8. Average sweat severity score of ≥4 at the end of screening. Subjects must complete the diary at least 4 times out of 7 days prior to baseline.

9. Females of childbearing potential must be willing to use an acceptable method of birth control during study participation and for 30 days after the last study drug application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), have been diagnosed as infertile, have same gender sex partner, or are postmenopausal for at least 1 year. Acceptable methods of contraception include: abstinence, oral contraceptives, contraceptive patches/implants, injectable contraceptives, double barrier methods (e.g., condom and spermicide), or an intra-uterine device (IUD). Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation and for 30 days after the last study drug application.

10. Males must either have been vasectomized or agree to use an acceptable method of birth control with female partners during study participation and for 30 days after the last study drug application.

11. Subjects must agree not to donate eggs or sperm (as applicable) during the trial.

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Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for study participation.

1. Prior surgical procedure for hyperhidrosis.

2. Iontophoresis for the palms within 4 weeks of Baseline.

3. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline. (Note: treatment with botulinum toxin in other areas is not exclusionary.)

4. Subjects who are actively participating in an experimental therapy study or who received experimental therapy within 30 days of 5 half-lives (whichever is longer) of the Baseline Visit.

5. For subjects that are taking concomitant medications that may have an effect on sweating (i.e., psychotherapeutic medications, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta blockers, the dose must be stable, in the opinion of the investigator, for two months prior to Baseline. There should be no expected medication changes over the course of the study unless deemed to be medically necessary. (Note: inhaled anticholinergic drugs or beta agonists are allowed.)

6. Intravenous (IV), oral, or topically glycopyrrolate treatment of any systemic treatment with an anticholinergic medication, such as atropine, belladonna, scopolamine, clindinium, or hyoscyamine within 4 weeks prior to Screening.

7. Current pregnancy or lactation per patient report.

8. Open wounds or inflammatory lesions on the hands, or any condition that may alter the barrier function of the skin on the hands.

9. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).

10. Known history of Sjögren's syndrome or Sicca syndrome.

11. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.

12. Men with a history of urinary retention requiring catherization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

13. History of ventricular arrhythmias, atrial fibrillation, atrial flutter.

14. Subjects with known medical procedures or surgeries that are scheduled to occur during the study.

15. Subjects who are a poor medical risk because of other systemic diseases or active, uncontrolled infections, or any other condition, which (in the judgement of the investigator) would put the subjects at unacceptable risk for participation in the study.

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