A Phase 2 interventional study of TTB gel (dose 1) and TTB gel (dose 2) in Palmar Hyperhidrosis, sponsored by Dryox Health. Terminated at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Dryox Health · Phase 2, Interventional, and Treatment
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.
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:
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:
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →This is the only study on the registry with Dryox Health as lead sponsor.
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.
Subjects must meet all the following criteria to be eligible for study participation:
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for study participation:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Victorhy (TTB, dose 1) topically to both hands, once daily for 28 days (20 participants)
Drug: TTB gel (dose 1)
Participants will receive Victorhy (TTB, dose 2) topically to both hands, once daily for 28 days (20 participants)
Drug: TTB gel (dose 2)
Participants will receive a vehicle gel topically to both hands, once daily for 28 days (20 participants)
Drug: Placebo
A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
Also known as: Victorhy
A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
Also known as: Victorhy
A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days
Mean absolute change in gravimetrically measured sweat production
Time frame: 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.
Time frame: From Day 1 to Day 29
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: From Day 1 to Day 35
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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