A phase 2, randomised, double-blind, vehicle-controlled, dose finding, efficacy, tolerability and safety study of Victorhy in patients with severe hand hyperhidrosis

Conditions

Severe primary hand hyperhidrosis

Brief summary

Mean absolute change from Day 1 in gravimetrically measured sweat production at Day 29., Mean change in HDSS at Day 29 from Day 1.

Detailed description

To assess the quality of life of the study participants with the Hyperhidrosis Quality of Life Index (HidroQol)., To assess the quality of life of the study participants with the DLQI, To assess the quality of life of the study participants with the EQ-5D-5L questionnaire., Local skin reactions., Number of adverse events per randomisation group., Number of patients within each Adverse Event per randomisation group., Type of Adverse Events per randomisation group., Number of Serious Adverse Events by randomisation group., Type of Serious Adverse Events by randomisation group., Number of Adverse Events of Special Interest by randomisation group., Type of Adverse Events of Special Interest by randomisation group., Treatment-related Adverse Events., Severity of Adverse Events., 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)., The determination of plasma levels of tiotropium bromide at pharmacokinetic steady state.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo Tiotropium Bromide Monohydrate Hydroalcoholic gel 0.5% w/w and 0.1% w/w

DRUGVictorhy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean absolute change from Day 1 in gravimetrically measured sweat production at Day 29., Mean change in HDSS at Day 29 from Day 1.	—

Secondary

Measure	Time frame
To assess the quality of life of the study participants with the Hyperhidrosis Quality of Life Index (HidroQol)., To assess the quality of life of the study participants with the DLQI, To assess the quality of life of the study participants with the EQ-5D-5L questionnaire., Local skin reactions., Number of adverse events per randomisation group., Number of patients within each Adverse Event per randomisation group., Type of Adverse Events per randomisation group., Number of Serious Adverse Events by randomisation group., Type of Serious Adverse Events by randomisation group., Number of Adverse Events of Special Interest by randomisation group., Type of Adverse Events of Special Interest by randomisation group., Treatment-related Adverse Events., Severity of Adverse Events., 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)., The determination of plasma levels of tiotropium bromide at pharmacokinetic steady state.	—

Measure

Time frame

To assess the quality of life of the study participants with the Hyperhidrosis Quality of Life Index (HidroQol)., To assess the quality of life of the study participants with the DLQI, To assess the quality of life of the study participants with the EQ-5D-5L questionnaire., Local skin reactions., Number of adverse events per randomisation group., Number of patients within each Adverse Event per randomisation group., Type of Adverse Events per randomisation group., Number of Serious Adverse Events by randomisation group., Type of Serious Adverse Events by randomisation group., Number of Adverse Events of Special Interest by randomisation group., Type of Adverse Events of Special Interest by randomisation group., Treatment-related Adverse Events., Severity of Adverse Events., 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)., The determination of plasma levels of tiotropium bromide at pharmacokinetic steady state.

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Countries

Spain

Outcome results

None listed