Palmar HyperhidrosisPhase 2NCT06645509
Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy
A Phase 2 study testing TTB gel (dose 1) and TTB gel (dose 2) in people with Palmar Hyperhidrosis, run by Dryox Health at 4 sites in Spain.
Trial summary
The objective of this study is to assess the efficacy and safety of Victorhy, a topical TTB gel in patients with severe primary hand hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmar Hyperhidrosis
- What is being tested?
- TTB gel (dose 1) and TTB gel (dose 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 4 sitesSpain
- Study dates
- 29 Apr 2024to 2 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following criteria to be eligible for study participation:
- To sign an informed consent.
- Be 18 years of age or older.
- Be willing to comply with the study protocol.
- Be males, or non-pregnant and non-lactating females (a negative urine pregnancy test is required for female participants of child-bearing potential).
- Have a primary hand hyperhidrosis diagnosis for at least 6 months.
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- Have a HDSS of 3 or 4 at randomization/day 1.
- Have a gravimetric test of at least 100 mg of sweat production at rest in each palm, and a sum of at least 250 mg in both palms, in 5 minutes (room temperature) AND/OR being on a waiting list for surgical sympathectomy.
- Be willing to discontinue their current treatment for primary hyperhidrosis.
- In the case of women and men of childbearing potential, for safety reasons, those who agree to follow the required contraceptive measures from the signing of the informed consent until the last study visit (day 35).
Who cannot join
- Subjects meeting any of the following criteria are not eligible for study participation:
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms 4 weeks prior to randomization.
- Treatment with botulinum toxin (e.g., Botox) for hand hyperhidrosis 6 months prior to randomization.
- Known allergy to any of the components in the investigational product, as well as to atropine or its derivatives, e.g., ipratropium or oxitropium.
- Subjects who are actively participating in an experimental therapy study or who received experimental therapy 30 days or 5 half-lives (whichever is longer) prior to randomization.
Show all 19Show fewer
- Subjects who have had a change in a regimen of psychotherapeutic medication (change in drug, dose, frequency) or who have started a psychoactive medication prior to two months of randomization.
- Treatment with medications having systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta-blockers 4 weeks prior to randomization.
- Treatment with Spiriva or similar, or any systemic treatment with an anticholinergic medication such as, but not limited to atropine belladonna, scopolamine, aclidinium, hyoscyamine, oxybutynin or glycopyrronium within 4 weeks prior to randomization.
- Prior diagnosis of asthma or Chronic Obstructive Pulmonary Disease (COPD).
- If female, current pregnancy or lactation.
- Patients with skin lesions or bruisers; open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
- Secondary hand hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
- Known history of Sjögren's syndrome or Sicca syndrome.
- Known history of neuromuscular disease.
- History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
- Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
- History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia with a ventricular rate greater than 100 (other than sinus tachycardia).
- Subjects who are a high medical risk because of other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)
Madrid, 28023
Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)
Málaga, 29016
Hospital Santa Caterina de Salt
Salt, Girona, 17190
Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)
Vigo, Pontevedra, 36206
About this study
Official title: A Phase 2, Randomised, Double-blind, Vehicle-controlled, Dose Finding, Efficacy, Tolerability and Safety Study of Victorhy in Patients With Severe Hand Hyperhidrosis
The objective of this study is to assess the efficacy and safety of Victorhy, a topical TTB gel in patients with severe primary hand hyperhidrosis.
Read the detailed description
This is a Phase II, multicenter, randomized, double-blind, parallel group and vehicle-controlled study in which participants with severe primary hand hyperhidrosis will be randomly assigned (1:1:1) to one of the following arms:
- Victorhy dose 1
- Victorhy dose 2
- Placebo (Vehicle gel)
This study will evaluate the efficacy of Victorhy, a topical TTB gel, in patients with severe primary hand hyperhidrosis. This trial will also assess the quality of life of study participants, the rebound effect, and the pharmacokinetics of topical TTB gel. The study is intended to assess a formulation including two different doses of Victorhy (treatment groups), compared to placebo (control group) with the objective of determining the optimal therapeutic dose for use in severe hand hyperhidrosis.
Objectives:
Primary objective: To assess the efficacy of a topical TTB gel in patients with severe primary hand hyperhidrosis.
Secondary objectives:
- To assess the tolerability and safety of topical TTB gel
- To determine the optimal therapeutic dose of topical TTB gel
- To assess the quality of life of study participants
- To assess the rebound effect
- Conditions
- Palmar Hyperhidrosis
- Being tested
- TTB gel (dose 1), TTB gel (dose 2), Placebo
- Keywords
- Hyperhidrosis, Palmar Hyperhidrosis, Primary Palmar Hyperhidrosis, Sweat Gland Diseases, Cholinergic Antagonists
- Medical subject headings
- Hyperhidrosis, Sweat Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTB gel (dose 1)Drug
Also called Victorhy
A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
TTB gel (dose 2)Drug
Also called Victorhy
A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
PlaceboDrug
A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Victorhy (dose 1) (TTB gel) | Experimental | Participants will receive Victorhy (TTB, dose 1) topically to both hands, once daily for 28 days (20 participants) Receives: Drug: TTB gel (dose 1) |
| Victorhy (dose 2) (TTB gel) | Experimental | Participants will receive Victorhy (TTB, dose 2) topically to both hands, once daily for 28 days (20 participants) Receives: Drug: TTB gel (dose 2) |
| Vehicle gel | Placebo comparator | Participants will receive a vehicle gel topically to both hands, once daily for 28 days (20 participants) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute change in gravimetrically measured sweat production
Measured: From Day 1 to Day 29
Mean change in Hyperhidrosis Disease Severity Scale (HDSS)
HDSS is a scale from grade 1 to grade 4 to measure the level of interference of sweat production with the patient's daily activities. It is the participants who give their subjective assessment, which may be:
- Grade 1: My sweating is never noticeable and never interferes with my daily activities.
- Grade 2: My sweating is tolerable but sometimes interferes with my daily activities.
- Grade 3: My sweating is barely tolerable and frequently interferes with my daily activities.
- Grade 4: My sweating is intolerable and always interferes with my daily activities.
Measured: From Day 1 to Day 29
Secondary outcomes (10)
Global Impression of Change
Overall impression of the hand sweating of the participants at day 29 compared to before treatment, ranging from 1 (much better) to 7 (much worse). It is the patients who provide their assessment of this outcome.
Measured: From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 1 grade improvement in HDSS
An improvement of 1 or more grades in the HDSS.
Measured: From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 2 grade improvement in HDSS
An improvement of 2 or more grades in the HDSS.
Measured: From Day 1 to Day 29
Proportion of participants who have at least a 50 percent reduction in gravimetrically measured sweat production
A positive case is defined as a patient who showed a reduction of 50 percent or more in gravimetrically measured sweat production compared to day 1.
Measured: From Day 1 to Day 29
Percent change in gravimetrically-measured sweat production
Percent change from day 1 to day 29 in the gravimetrically-measured sweat production.
Measured: From Day 1 to Day 29
Hyperhidrosis Quality of Life Index (HidroQoL) to Evaluate the Quality of Life of the Study Participants
The HidroQoL assesses how hyperhidrosis impacts Quality of life. With 18 items on two domains, it is a comprehensive measure. The first domain with six items refers to daily life activities and the second domain with 12 items covers the psychosocial life of participants. Each item has three response options (no, not at all = 0; a little = 1; very much = 2), with a total score range from 0 to 36. The higher the score, the greater the severity. To compute scores for each dimension, items must be summed. It is the patients who provide their assessment of this outcome.
Measured: From Day 1 to Day 29
Dermatology Life Quality Index (DLQI) to Evaluate Quality of Life of Study Participants
It consists of 10 questions referring to the past seven days. Each question of the questionnaire includes a Likert-type scale with four possible answers: "not at all", "a little", "a lot" or "very much", with scores of 0, 1, 2 and 3 respectively, with an additional option of "not relevant". The health domains included are symptoms and perceptions (questions 1, 2), daily activities (3, 4), leisure (5, 6), work/study (7), interpersonal relationships including sexuality (8, 9) and treatment (10). The sum of the scores provides a simple aggregate global value between 0 and 30, and the result can be presented as the percentage impact of the dermatologic condition on the patient's quality of life. The higher the score, the greater the impact on the patient's quality of life. It is the patients who provide their assessment of this outcome.
Measured: From Day 1 to Day 29
EQ-5D-5L Questionnaire to Evaluate the Quality of Life of the Study Participants
It is a standardized measure of health status that provides a simple, generic measure of health. It consists of 5 items in a 5-point Likert scale and a sixth item ranged from 0 to 100. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. It is the patients who provide their assessment of this outcome.
Measured: From Day 1 to Day 29
Local skins reactions (LSRs)
LSRs include burning/stinging, pruritus, oedema, erythema, dryness, and scaling. Each LSR will be scored as 0 (None), 1 (Mild), 2 (Moderate) or 3 (Severe). LSRs observed on a study visit day are not recorded as adverse events unless scored as 3 (Severe).
Measured: From Day 1 to Day 29
Rebound effect assessment
To assess if on Day 35 there is an increase of 1 or more over the HDSS value obtained on Day 29 (End of Treatment Visit).
Measured: From Day 1 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start29 Apr 2024
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Why it stopped: The trial was early terminated due to a slower patient accrual than expected. By the expiration date of the IMP batch manufactured for the trial (30 May 2025), only 58 patients were enrolled, below the planned N of 60.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dryox Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clara Matas Nada, MD, Principal investigator, Hospital Santa Caterina de SaltJosé Gregorio Álvarez Fernández, MD, Principal investigator, Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)Carmen Rodríguez Cerdeira, MD, Principal investigator, Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)Enrique Herrera Acosta, MD, Principal investigator, Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645509
- Sponsor's protocol ID
- Dry002-FiH
- Other IDs
- 2023-507114-27-00, 2023
- Status last verified
- Jun 2025
- First submitted
- 15 Oct 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomised, Double-blind, Vehicle-controlled, Dose Finding, Efficacy, Tolerability and Safety Study of Victorhy in Patients With Severe Hand Hyperhidrosis
- ClinicalTrials.gov ID
- NCT06645509
- Acronym / sponsor ID
- Dry002-FiH
- Conditions
- Palmar Hyperhidrosis
- Keywords
- Hyperhidrosis, Palmar Hyperhidrosis, Primary Palmar Hyperhidrosis, Sweat Gland Diseases, Cholinergic Antagonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was early terminated due to a slower patient accrual than expected. By the expiration date of the IMP batch manufactured for the trial (30 May 2025), only 58 patients were enrolled, below the planned N of 60.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Dryox HealthIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of Victorhy, a topical TTB gel in patients with severe primary hand hyperhidrosis.
Detailed description
This is a Phase II, multicenter, randomized, double-blind, parallel group and vehicle-controlled study in which participants with severe primary hand hyperhidrosis will be randomly assigned (1:1:1) to one of the following arms:
- Victorhy dose 1
- Victorhy dose 2
- Placebo (Vehicle gel)
This study will evaluate the efficacy of Victorhy, a topical TTB gel, in patients with severe primary hand hyperhidrosis. This trial will also assess the quality of life of study participants, the rebound effect, and the pharmacokinetics of topical TTB gel. The study is intended to assess a formulation including two different doses of Victorhy (treatment groups), compared to placebo (control group) with the objective of determining the optimal therapeutic dose for use in severe hand hyperhidrosis.
Objectives:
Primary objective: To assess the efficacy of a topical TTB gel in patients with severe primary hand hyperhidrosis.
Secondary objectives:
- To assess the tolerability and safety of topical TTB gel
- To determine the optimal therapeutic dose of topical TTB gel
- To assess the quality of life of study participants
- To assess the rebound effect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Victorhy (dose 1) (TTB gel) | Experimental | Drug: TTB gel (dose 1)Participants will receive Victorhy (TTB, dose 1) topically to both hands, once daily for 28 days (20 participants) |
| Victorhy (dose 2) (TTB gel) | Experimental | Drug: TTB gel (dose 2)Participants will receive Victorhy (TTB, dose 2) topically to both hands, once daily for 28 days (20 participants) |
| Vehicle gel | Placebo comparator | Drug: PlaceboParticipants will receive a vehicle gel topically to both hands, once daily for 28 days (20 participants) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To sign an informed consent.
- Be 18 years of age or older.
- Be willing to comply with the study protocol.
- Be males, or non-pregnant and non-lactating females (a negative urine pregnancy test is required for female participants of child-bearing potential).
- Have a primary hand hyperhidrosis diagnosis for at least 6 months.
Key exclusion criteria (19 listed)
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms 4 weeks prior to randomization.
- Treatment with botulinum toxin (e.g., Botox) for hand hyperhidrosis 6 months prior to randomization.
- Known allergy to any of the components in the investigational product, as well as to atropine or its derivatives, e.g., ipratropium or oxitropium.
- Subjects who are actively participating in an experimental therapy study or who received experimental therapy 30 days or 5 half-lives (whichever is longer) prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTB gel (dose 1)Also: VictorhyA topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days | Drug | Victorhy (dose 1) (TTB gel) |
| TTB gel (dose 2)Also: VictorhyA topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days | Drug | Victorhy (dose 2) (TTB gel) |
| PlaceboA topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days | Drug | Vehicle gel |
Primary outcome
Mean absolute change in gravimetrically measured sweat production
Time frame: From Day 1 to Day 29
Mean change in Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: From Day 1 to Day 29
HDSS is a scale from grade 1 to grade 4 to measure the level of interference of sweat production with the patient's daily activities. It is the participants who give their subjective assessment, which may be: * Grade 1: My sweating is never noticeable and never interferes with my daily activities. * Grade 2: My sweating is tolerable but sometimes interferes with my daily activities. * Grade 3: My sweating is barely tolerable and frequently interferes with my daily activities. * Grade 4: My sweating is intolerable and always interferes with my daily activities.
10 secondary outcomes
Global Impression of Change
Time frame: From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 1 grade improvement in HDSS
Time frame: From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 2 grade improvement in HDSS
Time frame: From Day 1 to Day 29
Proportion of participants who have at least a 50 percent reduction in gravimetrically measured sweat production
Time frame: From Day 1 to Day 29
Percent change in gravimetrically-measured sweat production
Time frame: From Day 1 to Day 29
Hyperhidrosis Quality of Life Index (HidroQoL) to Evaluate the Quality of Life of the Study Participants
Time frame: From Day 1 to Day 29
Dermatology Life Quality Index (DLQI) to Evaluate Quality of Life of Study Participants
Time frame: From Day 1 to Day 29
EQ-5D-5L Questionnaire to Evaluate the Quality of Life of the Study Participants
Time frame: From Day 1 to Day 29
Local skins reactions (LSRs)
Time frame: From Day 1 to Day 29
Rebound effect assessment
Time frame: From Day 1 to Day 35
Results and safety
The study was stopped early (reason given: The trial was early terminated due to a slower patient accrual than expected. By the expiration date of the IMP batch manufactured for the trial (30 May 2025), only 58 patients were enrolled, below the planned N of 60.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Matas Nada, MD principal investigator
Hospital Santa Caterina de Salt
José Gregorio Álvarez Fernández, MD principal investigator
Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)
Carmen Rodríguez Cerdeira, MD principal investigator
Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTB gel (dose 1) and TTB gel (dose 2) in people with Palmar Hyperhidrosis, run by Dryox Health at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was early terminated due to a slower patient accrual than expected. By the expiration date of the IMP batch manufactured for the trial (30 May 2025), only 58 patients were enrolled, below the planned N of 60.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute change in gravimetrically measured sweat production (time frame: From Day 1 to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.