Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
This study has been completed.
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01274611
First received: January 10, 2011
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
| Condition | Intervention |
|---|---|
|
Axillary Hyperhidrosis |
Drug: Botulinum Toxin Type A Device: Suction-Curettage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Measurement of Sweat Production using Gravimetry [ Time Frame: 10-12 weeks ] [ Designated as safety issue: No ]The primary outcome measure will be the reduction of sweat production in mg per min in both the resting state and the exercise-induced state.
Secondary Outcome Measures:
- Subject Satisfaction Using Disease Severity Scale [ Time Frame: 10-12 weeks, and 22-24 weeks ] [ Designated as safety issue: No ]The secondary outcome measure will be the reduction in mean score on the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is a widely accepted, subjective questionnaire that assigns a point value to the patient's view and tolerance of their disease.
| Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Suction-Curettage |
Device: Suction-Curettage
The doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
Other Name: liposuction
|
| Experimental: Botox |
Drug: Botulinum Toxin Type A
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
Other Name: botox
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Ages 18 to 65
- BMI 18.5 - 29.99
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- Subject is in good health
- Subject has the willingness and ability to understand and provide informed consent
Exclusion Criteria:
- Under age 18 or over age 65
- Pregnancy or lactating
- BMI ≥ 30 or ≤18.4
- Subjects who have undergone axillary suction/curettage any time in the past
- Subjects who have undergone axillary BT-A injections in the past year
- Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
- Subjects with a history of a bleeding disorder
- Subjects with an open, non-healing sore or infection near site of procedure
- Subjects with allergies to iodine, starch powder, albumin, or any botulinum toxin product
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274611
Locations
| United States, Illinois | |
| Northwestern University Feinberg School of Medicine, Department of Dermatology | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Murad Alam, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Murad Alam, Professor of Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01274611 History of Changes |
| Other Study ID Numbers: | STU40780 |
| Study First Received: | January 10, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
sweating sweat underarm axillary hyperhidrosis |
botox liposuction suction-curettage suction curettage |
Additional relevant MeSH terms:
|
Hyperhidrosis Sweat Gland Diseases Skin Diseases Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013