This trial is active, not recruiting.

Condition hyperhidrosis
Treatment drm04 topical wipes
Phase phase 3
Sponsor Dermira, Inc.
Start date August 2015
End date May 2017
Trial size 564 participants
Trial identifier NCT02553798, DRM04-HH06


This is an open-label, long-term safety study of DRM04 Topical Wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
DRM04 Topical Wipes
drm04 topical wipes
DRM04 Topical Wipes

Primary Outcomes

Long-term Safety assessed through adverse events and local skin reactions
time frame: Day 1 - Week 44

Secondary Outcomes

Gravimetric Measurement of Sweat Production
time frame: Day 1 - Week 44
Hyperhidrosis Disease Severity Scale (HDSS)
time frame: Day 1 - Week 44
Dermatology Life Quality Index (DLQI)
time frame: Day 1 - Week 44

Eligibility Criteria

Male or female participants at least 9 years old.

Inclusion Criteria: - Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance - Male or females Exclusion Criteria: - Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with DRM04 contraindicated - Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy - Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study

Additional Information

Official title An Open-label Study Assessing Long-term Safety of DRM04 in Subjects With Primary Axillary Hyperhidrosis
Description Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dermira, Inc..