A Phase 2 interventional study of WO3970 and Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use in Primary Axillary Hyperhidrosis, sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel · Phase 2, Interventional, and Treatment
The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
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.
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.
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 WO 3970 for topical application
Drug: WO3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Application of cream to each axilla
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only
Measurement of the Steady State systemic Levels of glycopyrronium
Time frame: Day-1, Day 1 to Day 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))
Time frame: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))
Time frame: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))
Time frame: Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))
Time frame: Day -1, Day 1 to 13, Day 16
Adverse events (AEs)
Time frame: Day -1 of study period 1 to Day 16
Clinical chemistry
Albumin, alkaline phosphatase, ALT, AST, BUN, calcium, chloride, CO2, creatinine, direct bilirubin, GGT, glucose, LDH (lactate dehydrogenase), phosphorus, potassium, sodium, total bilirubin, total cholesterol, total protein, uric acid
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hematology
Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Urinalysis
Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
BP
mmHg
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Respiratory rate
breaths per minute
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Temperature
°C
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Heart rate
bpm
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
12-lead ECG
beats per minute \[bpm\], PR, QRS, QT, QTc, QTcF, and QTcB interval
Time frame: Screening, Day 1-13 of study period 1 and period 2
Physical examination
General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities
Time frame: Screening, Day -1, Day 16
Local tolerability
Dermal Evaluation of erythema, edema and papules
Time frame: Day -1, Day 1-13, Day 16 of study period 1 and period 2
Sweat production by gravimetric measurement
5-minute measurement \[filter paper\] interval first without then repeated with an immediately preceded subject consumption of 250 mL of hot water swallowed within 1 minute
Time frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Disease Severity Scale (HDSS)
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: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Quality of Life Questionnaire (HydroQoL)
Hyperhidrosis Quality of Life Questionnaire (HydroQoL) is an 18-item, validated, Patient reported Outcome Hyperhidrosis Quality of life Instrument. It is devided into 2 Domains: A Daily Life Activities Domain (6 items) and a Psychosocial Domain (12 items). The items are scored on a 3-point scale (0=no, not at all, 1=a Little, 2=very much).
Time frame: Day -1, Day 1 to 13 of period 1 and period 2
No study locations are listed for this record.
Start is estimated for Dec 2019; primary completion for Oct 2020, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: WO3970
Dr. August Wolff GmbH & Co. KG Arzneimittel