Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial - 13/03/20

Doi : 10.1016/j.jaad.2020.02.016

Brandon Kirsch, MD ^a, Stacy Smith, MD ^b, Joel Cohen, MD ^c,^d, Janet DuBois, MD ^e, Lawrence Green, MD ^f, Leslie Baumann, MD ^g, Neal Bhatia, MD ^h, David Pariser, MD ⁱ, Ping-Yu Liu, PhD ^j, Deepak Chadha, MS, MBA ^a,^⁎ , Patricia Walker, MD, PhD ^a
^a Brickell Biotech, Inc, Boulder, Colorado
^b California Dermatology and Clinical Research Institute, Encinitas, California
^c AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado
^d Department of Dermatology, University of California, Irvine, California
^e DermResearch Inc, Austin, Texas
^f Department of Dermatology, George Washington University School of Medicine, Washington, DC
^g Baumann Cosmetic and Research Institute, Miami, Florida
^h Therapeutics Clinical Research, San Diego, California
ⁱ Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia
^j Fred Hutchinson Cancer Research Center, Seattle, Washington

^∗Correspondence and reprint requests to: Deepak Chadha, MS, MBA, Brickell Biotech, Inc, 5777 Central Ave, Ste 102, Boulder, CO 80301.Brickell Biotech, Inc5777 Central AveSte 102BoulderCO80301

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 13 March 2020

Abstract

Background

Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.

Objective

To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.

Methods

A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.

Results

At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05). Least-square mean (SE) changes in HDSM-Ax were −2.02 (0.14), −2.09 (0.14), 2.10 (0.14), and −1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.

Limitations

Not powered to detect changes in gravimetric sweat production.

Conclusion

Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

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Key words : anticholinergic, axillary hyperhidrosis, HDSM-Ax, retrometabolic drug, sofpironium bromide, topical

Abbreviations used : ANCOVA, DLQI, EOT, GSP, HDSM-Ax, HDSS

Plan

Methods

Study design and procedures

Safety and tolerability

Discussion

Conclusions

	Dr Kirsch is currently affiliated with Kirsch Dermatology, Naples, Florida. Dr Walker is currently affiliated with Walker Dermatology, Carpinteria, California.
	Funding sources: The study and preparation of the manuscript were supported by Brickell Biotech, Inc.
	Conflicts of interest: Drs Smith, Cohen, DuBois, Green, Baumann, Bhatia, and Pariser have participated in clinical trials with Brickell Biotech. Dr Kirsch was formerly the Medical Director and Vice President of Clinical Development for Brickell Biotech. Deepak Chadha is an employee of Brickell Biotech. Dr Liu is a consultant to Brickell Biotech. Dr Walker was formerly the President and Chief Scientific Officer of Brickell Biotech.
	IRB approval status: The study was approved by the Aspire Institutional Review Board, Santee, California.