Comparator Study of the Effect of DRM04B and DRM 04 in Subjects With Axillary Hyperhidrosis
This trial is active, not recruiting.
|Treatments||dose 1 of drm04b, dose 2 of drm04b, dose 1 of drm04, dose 2 of drm04, vehicle|
|Start date||April 2014|
|End date||December 2014|
|Trial size||100 participants|
|Trial identifier||NCT02129660, DRM04-HH02|
The purpose of the study is to assess the safety of 2 doses of DRM04B compared to 2 doses of DRM04 and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Encinitas, CA||California Dermatology & Clinical Research Institute||no longer recruiting|
|Fremont, CA||Center For Dermatology Clinical Research||no longer recruiting|
|Tampa, FL||Olympian Clinical Research||no longer recruiting|
|West Palm Beach, FL||Kenneth R. Beer MD||no longer recruiting|
|Carmel, IN||Shideler Clinical Research Center||no longer recruiting|
|Saint Louis, MO||Saint Louis University Dermatology||no longer recruiting|
|Beachwood, OH||Haber Dermatology and Cosmetic Surgery||no longer recruiting|
|Goodlettsville 37072, TN||Rivergate Dermatology Clinical Research Center, PLLC||no longer recruiting|
|Austin, TX||DermResearch, Inc||no longer recruiting|
|Salt Lake City, UT||Dermatology Research Center, Inc.||no longer recruiting|
|Norfolk, VA||Virginia Clinical Research, Inc.||no longer recruiting|
|Seattle, WA||Dermatology Associates||no longer recruiting|
|Seattle, WA||Women's Clinical Research Center||no longer recruiting|
|Spokane, WA||Premier Clinical Research||no longer recruiting|
|Montreal, Canada||Innovaderm Research Inc.||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Proportion of subjects who have a minimum 1-grade improvement in HDSS from Baseline at Week 4
time frame: Week 4
Proportion of subjects who have a minimum 2-grade improvement in HDSS from Baseline at Week 4
time frame: Week 4
Absolute change in the gravimetrically measured sweat production from Baseline to Week 4
time frame: Week 4
Absolute change in the gravimetrically measured sweat production from Baseline to Week 6
time frame: Week 6
Proportion of subjects who have a minimum 1-grade improvement in HDSS from Baseline at Week 6
time frame: Week 6
Male or female participants at least 18 years old.
- Male or female, 18 years of age or older.
- Primary, axillary hyperhidrosis of at least 6 months duration.
- Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
- Male or non-pregnant, non-lactating females.
- Current pregnancy or lactation.
- Prior surgical procedure for hyperhidrosis.
- Any prior axillary treatment with an anti-hyperhidrosis medical device
- Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
- Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
- Subjects with clinically significant abnormalities in laboratory values.
- Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
- Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
- Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
- Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
- Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
- Any previous IV or oral treatment with the study drug.
- Prior treatment with the topical study drug in a previous trial.
- Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
- Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
- Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
- Known history of Sjögren's syndrome or Sicca syndrome.
- History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
- Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
- Abnormal findings on screening ECG deemed clinically significant by the Investigator.
- History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia
|Official title||A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of DRM04B and DRM04 in Subjects With Axillary Hyperhidrosis|
|Description||This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of DRM04B compared to two doses of DRM04 compared to vehicle, 5 treatment arms. Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS). Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs. PK blood samples will be taken study subjects.|
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