A Phase 3 interventional study of WO3970 and Placebo (WO3988) in Primary Axillary Hyperhidrosis, sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel · Phase 3, Interventional, and Treatment
The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 518 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Dr. August Wolff GmbH & Co. KG Arzneimittel is the lead sponsor of 18 studies on the registry; none are open to participants now.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Formulation containing WO3979 for topical application
Drug: WO3970
Formulation containing Placebo of WO3988 for topical application
Drug: Placebo (WO3988)
Application of cream to each axilla
Application of cream to each axilla
Dose-confirming part: Absolute change in sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared with the placebo group.
Time frame: Baseline (Day 1a), Day 29
Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12
Time frame: Baseline (Day 1b), Week 12
Dose-confirming part: Percentage of responders assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (≥2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group
The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS is a four item scale. A score of 1 or 2 indicates mild or moderate Hyperhidrosis. A score of 3 or 4 indicates severe Hyperhidrosis.
Time frame: Day 29
Dose-confirming part: Percentage of responders assessed by GM at Day 29 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline) in the 1% GPB group compared with the placebo group
Time frame: Day 29
Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12
Time frame: Week 12
Long-term part: Percentage of responders assessed by GM at Week 4 and Week 12 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline
Time frame: Week 4, Week 12
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: WO3970
Dr. August Wolff GmbH & Co. KG Arzneimittel