N/A
N=28
A Non-Interventional Study To Assess Sweating
Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT02552199 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers). — 0.7687; 0.1762 grams
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- gravimetric (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Botanix Pharmaceuticals
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers). |
0.7687; 0.1762 | — |
Summary
To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.
Eligibility Criteria
Inclusion Criteria
- Females should not be pregnant or lactating.
- For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
- For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline
Exclusion Criteria
- Recent therapeutic interventions or treatments for palmar hyperhidrosis
- Any major illness within 30 days before the screening
- Females who are pregnant, lactating, or planning a pregnancy
Data sourced from ClinicalTrials.gov (NCT02552199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.