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Phase III trial of DRM 04 shows significant improvements in hyperhidrosis- Dermira

Read time: 1 mins
Last updated: 1st Oct 2016
Published: 1st Oct 2016
Source: Pharmawand

Dermira has presented data, including new disease-related quality of life data, from its DRM 04 Phase III clinical program in patients with primary axillary hyperhidrosis (excessive underarm sweating). In June 2016, positive topline results from the Phase III ATMOS-1 and ATMOS-2 pivotal trials evaluating the safety and efficacy of DRM 04, a topical anticholinergic product candidate, compared to vehicle were reported showing significant improvements in patient-reported disease severity following four weeks of treatment. New findings presented at EADV found that patients treated with DRM04 reported significant improvements in their disease-related quality of life compared to patients who received vehicle only.

DRM04 showed a mean improvement from baseline in the Dermatology Life Quality Index (DLQI) score compared to vehicle in both the ATMOS-1 (decrease of 8.1 vs. 4.3) and ATMOS-2 (decrease of 8.6 vs. 5.0) clinical trials, at week 4. A decrease in a patient�s DLQI score translates to overall improved satisfaction in the management of their skin condition. DLQI is a widely used and recognized quality of life measurement instrument frequently used across several dermatologic conditions. Dermira intends to present additional patient quality of life data as measured by the Axillary Sweating Daily Diary (ASDD), its proprietary patient-reported outcome (PRO) instrument, in peer-reviewed forums. Data were presented at the 25th European Academy of Dermatology and Venereology Congress.

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