CompletedPhase 2

An Open Label Study for Palmar Hyperhydrosis

United States120 participantsStarted 2020-10-01

Plain-language 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

Who can participate

Age range9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must provide fully executed informed e-consent and e-assent (if applicable) prior to any study procedures.
✓. Age ≥ 9 years.
✓. Willing to comply with the protocol, including completion of designated virtual study visits and prescribed study treatment regimens.
✓. 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.
✓. 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.)
✓. 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.)
✓. Primary palmar hyperhidrosis for at least 6 months.
✓. 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.

Exclusion criteria

✕. Prior surgical procedure for hyperhidrosis.
✕. Iontophoresis for the palms within 4 weeks of Baseline.
✕. 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.)
✕. 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.
✕. 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.)
✕. 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.
✕. Current pregnancy or lactation per patient report.
✕. Open wounds or inflammatory lesions on the hands, or any condition that may alter the barrier function of the skin on the hands.

What they're measuring

Mean change of the average hand sweating score (Daily Diary Question 1) from the week of Screen-Baseline to the final week of study treatment.

Timeframe: From the week of Screen-Baseline (7 days prior to the end of the screening visit) to the final week of study treatment (week 4).

Proportion of subjects who have a >2 grade improvement in HDSS from baseline to week 4.

Timeframe: From Baseline to week 4.

Trial details

NCT IDNCT04906655

SponsorPariser, Robert J., M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-20

View on ClinicalTrials.gov More Palmar Hyperhidrosis trials