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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00011603 | Registry Identifier | DRKS |
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To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfocused ultrasound with visualization | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfocused ultrasound with visualization | Device | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 60 (30 days post second treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosenpark Research, Study Research Center; Merz Investigational Site #0490099 | Darmstadt | 64283 | Germany | |||
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A total of 20 participants were screened, enrolled and treated in the study.
The study was conducted at 2 sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultherapy Treatment | Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 millimeter (mm) using 7-megahertz (MHz) transducer with 0.30 joules (J) of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultherapy Treatment | Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All evaluable treated participants in FAS who received a complete or partial study treatment and completed a follow-up visit at Day 30 post second treatment. The FAS was the subset of participants in SES for whom primary efficacy variable was available. The SES was the subset of all participants who were exposed to study treatment at least once. | Posted | Number | participants | Day 60 (30 days post second treatment) |
Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultherapy Treatment | Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2016 | Jun 17, 2019 | Prot_SAP_000.pdf |
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|
| 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. | 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. | Days 60 (30 days post second treatment) and 120 (90 days post second treatment) |
| Haut- & Laserzentrum, Merz Investigational Site #0490362 |
| Potsdam |
| 14467 |
| Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Fitzpatrick Skin Type | Skin type I = white; very fair, red or blonde hair blue eyes; freckles; always burns, never tans, skin type II = white, fair, red or blond hair; blue, hazel or green eyes; usually burns, tans with difficulty, skin type III = cream white; fair with any eye or hair color (common); sometimes mild burn, gradually tans, skin type IV = brown; typical Mediterranean Caucasian skin; rarely burns, tans with ease, skin type V = dark brown; mid-eastern skin types; very rarely burns, tans easily, and skin type VI = black; never burns, tans very easily. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ultherapy Treatment | Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square. |
|
|
| Secondary | 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). | The FAS was the subset of participants in the 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). The SES was the subset of all participants who were exposed to study treatment at least once. | Posted | Number | participants | Day 120 (90 days post second treatment) |
|
|
|
| Secondary | 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. | The FAS was the subset of participants in the 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). The SES was the subset of all participants who were exposed to study treatment at least once. | Posted | Number | participants | Days 60 (30 days post second treatment) and 120 (90 days post second treatment) |
|
|
|
| Secondary | 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. | The FAS was the subset of participants in the 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). The SES was the subset of all participants who were exposed to study treatment at least once. | Posted | Number | participants | Days 60 (30 days post second treatment) and 120 (90 days post second treatment) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 18 |
| 20 |
| Tingling | Nervous system disorders | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| Tenderness | General disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neuritis | Nervous system disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.