An interventional study of Microfocused ultrasound with visualization in Axillary Hyperhidrosis, sponsored by Ulthera, Inc. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Ulthera, Inc (part of Merz Pharma) · Not applicable, Interventional, and Treatment
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Ulthera, Inc is the lead sponsor of 46 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted after Ulthera, Inc became part of Merz Pharma.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Microfocused ultrasound with visualization
Subjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3\*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.)
Also known as: Ultherapy, Ulthera treatment
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Time frame: Day 60 (30 days post second treatment)
Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
Treatment success was defined as an HDSS score reduction from a value of a 3 or 4 to a 1 or 2 at 90-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Time frame: Day 120 (90 days post second treatment)
Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Treatment success for gravimetric sweat production test was defined as a 50% or more reduction in spontaneous sweat production compared to baseline at 30 days and 90 days post second treatment. Gravimetric sweat production was measured using a pre-weighed filter paper placed into the axilla for a period of 5 minutes. The paper was removed and weighed and rate of sweat production was calculated in milligram per 5 minute (mg/5 min) based on the difference in end-weight and pre-weight.
Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Improvement for the starch iodine test was defined as a reduction in the dark blue starch iodine area, both the left and right axilla needed to show improvement for a participant to be classified as improved. The starch iodine test was used to assess the area involved in excessive sweating by visually identifying areas that were actively producing sweat. The test was performed by applying iodine solution to the axilla and allowing the solution to dry. After drying, starch was sprinkled on the area. The light-brown iodine color turns dark purple as iodine-starch complexes form in the liquid medium with the sweat rising to the surface of the affected area. Starch iodine test was captured with digital images.
Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
The study was conducted at 2 sites in Germany.
| Milestone | Ultherapy Treatment |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
| participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment | 11 |
Treatment success was defined as an HDSS score reduction from a value of a 3 or 4 to a 1 or 2 at 90-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
| participants | Ultherapy Treatment |
|---|---|
| Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment | 15 |
Treatment success for gravimetric sweat production test was defined as a 50% or more reduction in spontaneous sweat production compared to baseline at 30 days and 90 days post second treatment. Gravimetric sweat production was measured using a pre-weighed filter paper placed into the axilla for a period of 5 minutes. The paper was removed and weighed and rate of sweat production was calculated in milligram per 5 minute (mg/5 min) based on the difference in end-weight and pre-weight.
| participants | Ultherapy Treatment |
|---|---|
| Day 60 | 12 |
| Day 120 | 15 |
Improvement for the starch iodine test was defined as a reduction in the dark blue starch iodine area, both the left and right axilla needed to show improvement for a participant to be classified as improved. The starch iodine test was used to assess the area involved in excessive sweating by visually identifying areas that were actively producing sweat. The test was performed by applying iodine solution to the axilla and allowing the solution to dry. After drying, starch was sprinkled on the area. The light-brown iodine color turns dark purple as iodine-starch complexes form in the liquid medium with the sweat rising to the surface of the affected area. Starch iodine test was captured with digital images.
| participants | Ultherapy Treatment |
|---|---|
| Day 60 | 16 |
| Day 120 | 20 |
Collected over Baseline up to Day 120. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultherapy Treatment | 0/20 (0%) | 0/20 (0%) | 18/20 (90%) |
| Event | Ultherapy Treatment |
|---|---|
| HematomaGeneral disorders | 16/20 |
| TinglingNervous system disorders | 8/20 |
| TendernessGeneral disorders | 3/20 |
| HeadacheNervous system disorders | 2/20 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 2/20 |
| GastritisGastrointestinal disorders | 1/20 |
| NauseaGastrointestinal disorders | 1/20 |
| NeuritisNervous system disorders | 1/20 |
| SwellingGeneral disorders | 1/20 |
Full analysis set (FAS) was the subset of participants in the safety evaluation set (SES) for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). SES was the subset of all participants who were exposed to study treatment at least once.
| Age, Continuous(years) | Ultherapy Treatment |
|---|---|
| Mean | 40.3 ± 10.9 |
| Sex: Female, Male(Participants) | Ultherapy Treatment |
|---|---|
| Female | 16 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Ultherapy Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ultherapy Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Ultherapy Treatment |
|---|---|
| Germany | 20 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | Ultherapy Treatment |
|---|---|
| Mean | 24.1 ± 4.0 |
| Fitzpatrick Skin Type(Participants) | Ultherapy Treatment |
|---|---|
| Skin Type I | 0 |
| Skin Type II | 15 |
| Skin Type III | 4 |
| Skin Type IV | 1 |
| Skin Type V | 0 |
| Skin Type VI | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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