CompletedNCT03880266Updated Aug 25, 2021Results posted

A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

A Phase 2 interventional study of Glycopyrronium cloth, 2.4% and Vehicle in Palmar Hyperhidrosis, sponsored by Journey Medical Corporation. Completed at 7 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Journey Medical Corporation · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 9 Years and older
Sex: All

Study summary

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

Read the detailed description

This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Conditions studied

Palmar Hyperhidrosis

Browse trials for

Hyperhidrosis 111

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 72 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Journey Medical Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Signed and assent (for subjects under legal adult age).
Age ≥9 years.
Primary palmar hyperhidrosis for at least 6 months duration.
Average sweat severity score of ≥4 at Baseline.
Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
Male or non-pregnant (negative urine pregnancy test in female subjects of ), non-lactating females.

Exclusion criteria

Exclusion Criteria:

Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
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.
Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
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).
Known history of Sjögren's syndrome or Sicca syndrome.
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.
Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Active comparator
Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Drug: Glycopyrronium cloth, 2.4%
Placebo comparator
Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Drug: Vehicle
Active comparator
Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Drug: Glycopyrronium cloth, 2.4%
Placebo comparator
Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Drug: Vehicle
Active comparator
Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Drug: Glycopyrronium cloth, 2.4%
Placebo comparator
Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
Drug: Vehicle
Active comparator
Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Drug: Glycopyrronium cloth, 2.4%
Placebo comparator
Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Drug: Vehicle

Interventions

DrugGlycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
DrugVehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

What researchers measure

Primary outcomes

Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].
Time frame: Baseline, Week 2

Secondary outcomes

Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (better), 2, 3, 4 (worse)
Time frame: Baseline, Week 2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Time frame: Baseline, Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Time frame: Baseline, Week 2
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Time frame: Baseline, Week 2

Results

Posted Mar 15, 2021

Limitations and caveats

Small sample size

Participant flow

Participant flow — Overall Study
Milestone	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Started	12	6	12	4	12	6	13	7
Completed	12	5	11	4	12	6	13	7
Not completed	0	1	1	0	0	0	0	0
Withdrew: Withdrawal by subject	0	1	1	0	0	0	0	0

Outcome measures

PrimaryMean Change From Baseline to Week 2 in Hand Sweating Severity Score

The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].

Time frame:: Baseline, Week 2
Reported as:: Mean · score on a scale

Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
score on a scale	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score	-2.14 ± 2.199	-0.56 ± 0.730	-1.64 ± 1.410	-3.03 ± 2.161	-2.53 ± 2.223	-2.20 ± 1.084	-1.30 ± 2.062	-1.34 ± 1.909

Statistical analysis

Group 1 Active vs Group 1 Vehicle · Wilcoxon (Mann-Whitney) · p = 0.244 · Mean difference (final values): -1.58 · 95% CI -3.76 to 0.60
Group 2 Active vs Group 2 Vehicle · Wilcoxon (Mann-Whitney) · p = 0.168 · Mean difference (final values): 1.39 · 95% CI -0.65 to 3.43
Group 3 Active vs Group 3 Vehicle · Wilcoxon (Mann-Whitney) · p = 0.699 · Mean difference (final values): -0.33 · 95% CI -2.39 to 1.72
Group 4 Active vs Group 4 Vehicle · Wilcoxon (Mann-Whitney) · p = 0.833 · Mean difference (final values): 0.04 · 95% CI -1.94 to 2.02

SecondaryPercentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2

Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (better), 2, 3, 4 (worse)

Time frame:: Baseline, Week 2
Reported as:: Count of participants · Participants

Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
Participants	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2	3	0	1	2	1	2	3	2

Statistical analysis

Group 1 Active vs Group 1 Vehicle · Fisher Exact · p = 1.000
Group 2 Active vs Group 2 Vehicle · Fisher Exact · p = 0.589
Group 3 Active vs Group 3 Vehicle · Fisher Exact · p = 0.154
Group 4 Active vs Group 4 Vehicle · Fisher Exact · p = 0.646

SecondaryMean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2

Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2

Time frame:: Baseline, Week 2
Reported as:: Mean · mg

Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
mg	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2	-69.8 ± 162.54	136.7 ± 320.57	-15.3 ± 53.14	-159.4 ± 354.38	-113.5 ± 164.10	38.1 ± 106.30	-58.6 ± 139.70	102.0 ± 767.52

Statistical analysis

Group 1 Active vs Group 1 Vehicle · t-test, 2 sided · p = 0.093 · Mean difference (final values): -206.5 · 95% CI -451.9 to 38.9
Group 2 Active vs Group 2 Vehicle · t-test, 2 sided · p = 0.186 · Mean difference (final values): 144.1 · 95% CI -78.6 to 366.7
Group 3 Active vs Group 3 Vehicle · t-test, 2 sided · p = 0.058 · Mean difference (final values): -151.7 · 95% CI -309.0 to 5.7
Group 4 Active vs Group 4 Vehicle · t-test, 2 sided · p = 0.186 · Mean difference (final values): 160.6 · 95% CI -611.2 to 290.1

SecondaryMean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2

Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production

Time frame:: Baseline, Week 2
Reported as:: Mean · Percent change

Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Percent change	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2	-17.1 ± 28.26	16.5 ± 60.4	-7.5 ± 65.53	-31.8 ± 51.29	-26.8 ± 39.17	11.4 ± 34.96	-17.7 ± 40.43	21.7 ± 145.81

Statistical analysis

Group 1 Active vs Group 1 Vehicle · t-test, 2 sided · p = 0.130 · Mean difference (final values): -33.62 · 95% CI -78.42 to 11.17
Group 2 Active vs Group 2 Vehicle · t-test, 2 sided · p = 0.518 · Mean difference (final values): 24.26 · 95% CI -54.62 to 103.13
Group 3 Active vs Group 3 Vehicle · t-test, 2 sided · p = 0.061 · Mean difference (final values): -38.14 · 95% CI -78.32 to 2.03
Group 4 Active vs Group 4 Vehicle · t-test, 2 sided · p = 0.366 · Mean difference (final values): -39.34 · 95% CI -128.40 to 49.72

SecondaryPercentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2

Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group

Time frame:: Baseline, Week 2
Reported as:: Count of participants · Participants

Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Participants	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2	1	1	3	2	4	0	2	3

Statistical analysis

Group 1 Active vs Group 1 Vehicle · Fisher Exact · p = 0.515
Group 2 Active vs Group 2 Vehicle · Fisher Exact · p = 0.560
Group 3 Active vs Group 3 Vehicle · Fisher Exact · p = 0.245
Group 4 Active vs Group 4 Vehicle · Fisher Exact · p = 0.290

Adverse events

Collected over Baseline through Week 2. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1 Active	0/12 (0%)	0/12 (0%)	5/12 (41.7%)
Group 1 Vehicle	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Group 2 Active	0/12 (0%)	0/12 (0%)	5/12 (41.7%)
Group 2 Vehicle	0/4 (0%)	0/4 (0%)	1/4 (25%)
Group 3 Active	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Group 3 Vehicle	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Group 4 Active	0/13 (0%)	0/13 (0%)	2/13 (15.4%)
Group 4 Vehicle	0/7 (0%)	0/7 (0%)	0/7 (0%)

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle
StomatitisGastrointestinal disorders	0/12	0/6	0/12	1/4	0/12	0/6	0/13	0/7
Dry MouthGastrointestinal disorders	1/12	1/6	2/12	0/4	0/12	0/6	0/13	0/7
Abdominal pain upperGastrointestinal disorders	0/12	0/6	0/12	0/4	0/12	1/6	0/13	0/7
Viral upper respiratory tract infectionInfections and infestations	0/12	0/6	1/12	0/4	0/12	1/6	0/13	0/7
Thermal burnInjury, poisoning and procedural complications	0/12	1/6	0/12	0/4	0/12	0/6	0/13	0/7
Skin exfoliationSkin and subcutaneous tissue disorders	0/12	0/6	0/12	0/4	0/12	1/6	0/13	0/7
InfluenzaInfections and infestations	1/12	0/6	0/12	0/4	0/12	0/6	0/13	0/7
NasopharyngitisInfections and infestations	0/12	0/6	1/12	0/4	0/12	0/6	0/13	0/7
Compensatory sweatingInjury, poisoning and procedural complications	1/12	0/6	1/12	0/4	0/12	0/6	0/13	0/7
Dry eyeEye disorders	1/12	0/6	0/12	0/4	0/12	0/6	0/13	0/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
Mean	29.2 ± 8.95	34.5 ± 15.93	29.2 ± 11.57	47.5 ± 17.56	28.2 ± 12.45	32.5 ± 7.97	26.6 ± 9.54	37.1 ± 13.91	31.1 ± 12.27

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
Female	8	4	7	4	8	3	8	5	47
Male	4	2	5	0	4	3	5	2	25

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
American Indian or Alaska Native	0	1	0	0	0	0	0	0	1
Asian	1	0	1	0	0	1	0	0	3
Native Hawaiian or Other Pacific Islander	1	1	2	0	1	0	1	2	8
Black or African American	1	0	0	0	0	0	0	0	1
White	8	4	7	4	9	4	12	5	53
More than one race	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	2	0	2	1	0	0	6

Region of Enrollment
Region of Enrollment(participants)	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
United States	12	6	12	4	12	6	13	7	72

Hand Sweat Severity Score
Hand Sweat Severity Score(units on a scale)	Group 1 Active	Group 1 Vehicle	Group 2 Active	Group 2 Vehicle	Group 3 Active	Group 3 Vehicle	Group 4 Active	Group 4 Vehicle	Total
Mean	6.78 ± 1.646	7.40 ± 0.718	7.56 ± 1.450	8.10 ± 1.920	6.93 ± 1.689	7.37 ± 2.017	7.58 ± 1.399	8.01 ± 1.078	7.37 ± 1.51

Study locations

7 sites

California Dermatology & Clinical Research Institute
Encinitas, California 92024, United States
Colorado Medical Research Center, Inc.
Denver, Colorado 80210, United States
International Dermatology Research, Inc.
Miami, Florida 33144, United States
The Indiana Clinical Trials Center
Plainfield, Indiana 46168, United States
Saint Louis University Dermatology
Saint Louis, Missouri 63122, United States
Innovative Dermatology/ ACRC Trials
Plano, Texas 75024, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia 23502, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Dec 11, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03880266
Lead sponsor: Journey Medical Corporation
Responsible party: Sponsor
First posted: Mar 19, 2019
Start date: Feb 22, 2019
Primary completion: May 24, 2019
Completion: May 24, 2019
Results posted: Mar 15, 2021
Last update: Aug 25, 2021

Study contacts

Kate Doherty

study director · Dermira, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

Study summary

Conditions studied

Browse trials for

In context

Hyperhidrosis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria