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Aesthetic Archives - JDDonline - Journal of Drugs in Dermatology

Developing a Topical Adjunct to Injectable Procedures

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“In vivo testing of bruising resolution demonstrated that at day 2/3, participants using the study product (INhance Post-Injection Serum with TriHex Technology®, Alastin Skincare, Inc. Carlsbad, CA) had 73% less bruise color intensity and statistically significant improvement over the bland moisturizer. “

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Developing a Topical Adjunct to Injectable Procedures

New JDD study reveals 81% of subjects applying a topical product had less bruising at day 2/3 compared to the bland moisturizer.

Injectable procedures have come to play an enormous part in everyday  aesthetic medical practice. Whether its use is directed at volumizing with fillers, decreasing volume using enzymes, skin-tightening using multi-needle approaches, or neuromuscular blockade, the injectable route is the means of delivery in all these cases, making injectable procedures the most common aesthetic procedure performed.

As with all procedures, expected and unexpected consequences may follow including bruising, swelling, discomfort, and the possibility of infection. This paper outlines the scientific process and validation of a product designed as an adjunct to injection therapy and the scientific deep dive needed to encompass both symptomatic and adjunctive purposes. On the symptomatic side, bruising, swelling, and pain were considered, while volumetric enhancement, regeneration, and anti-microbial/biofilm effects were desired outcomes from the adjunctive perspective.

Utilizing peptides and active agents aimed at reducing excess residual iron and stimulating macrophage absorption of red blood cells, we were able to achieve efficient resolution of bruising. In addition, peptides were included to stimulate collagen, elastin, and hyaluronic acid in synergy with the injectable. Anti-inflammatory, antimicrobial, and antibiofilm agents were added to aid in the safety profile of the injectable.

In vivo testing of bruising resolution demonstrated that at day 2/3, participants using the study product (INhance Post-Injection Serum with TriHex Technology®, Alastin Skincare, Inc. Carlsbad, CA) had 73% less bruise color intensity and statistically significant improvement over the bland moisturizer. Overall, 81% of subjects applying the study topical product had less bruising at day 2/3 compared to the bland moisturizer.

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JDD Article Referenced in this Post

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Facial Skin Tightening With Microfocused Ultrasound and Dermal Fillers: Considerations for Patient Selection and Outcomes

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Long Term Use of Novel Therapeutic for Topical Treatment of Primary Axillary Hyperhidrosis in Pediatric Subjects

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Source: ODAC Dermatology, Aesthetic & Surgical Conference (ODAC) Discovery in Dermatology Poster Session

At the 17th Annual ODAC Dermatology, Aesthetic, and Surgical Conference (ODAC) held January 17-20 in Orlando, FL, Brandon Kirsch, MD, Janet DuBois, MD, Martin N. Zaiac, MD and Deepak Chadha, MS, MBA, RAC presented scientific research of long term data with a novel therapeutic for topical treatment of primary axillary hyperhidrosis in pediatric subjects.

Discovery in Dermatology

The use of retro-metabolically designed drugs in dermatology is novel and has the potential for providing significant therapeutic benefit to pediatric and adult patients.

Sofpironium bromide is an ester analogue of glycopyrrolate that inhibits muscarinic receptors in sweat glands. It was developed according to the principles of retro-metabolic drug design, in which the goal is to create an active compound that is metabolized in vivo to an inactive moiety in a single, predictable reaction. Retro-metabolically designed drugs are rapidly metabolized in the bloodstream, potentially allowing for optimal therapeutic effect at application sites with minimal systemic side effects.

Introduction

~2.1% of the US population aged <18 years has primary hyperhidrosis (HH); ~65% have axillary HH. Long-term safety/tolerability and efficacy of topical HH treatments have rarely been studied in pediatric patients. Sofpironium bromide is a retro-metabolically designed analog of glycopyrrolate (anticholinergic) in development for topical treatment of primary axillary HH. Absorbed drug is rapidly metabolized, potentially allowing optimal local therapeutic effect with minimal systemic effects..

Procedures

21 of 25 subjects (age 9-16 yrs) with primary axillary HH of ≥6 months duration, completing a previous 1-week safety and pharmacokinetic (PK) study (BBI-4000-CL-105), were enrolled. Objectives were to assess safety/tolerability and PK, and explore efficacy of sofpironium bromide gel, 15% applied to both axillae for 24 weeks.

Results

Mean age (SD) 13.3 (2.29) years. 16 subjects completed this 24-week study. 7 had treatment emergent adverse events (TEAEs); 4 with AEs related to study drug, including expected systemic anticholinergic AEs (blurred vision, dry mouth, dry eyes, mydriasis) and local events (pain, pruritus, rash, erythema). 2 subjects discontinued due to TEAEs, including dry eye, dry mouth, local pruritus, local rash. The majority (52.4%) of subjects did not have any local symptoms/signs, and none observed were severe in nature. PK did not show evidence of drug/major metabolite accumulation, with most subjects having concentrations not quantifiable. The validated patient-reported outcome, Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax), showed mean (SD) change from baseline (from previous study) to Week 24 of this study of -1.91 (1.038). A -1.00 change shows clinically meaningful improvement.

Conclusion

In this 24-week study in pediatric subjects sofpironium bromide, 15% was safe/well tolerated. Majority of subjects had no TEAE, and there were no severe or serious AEs. There was no evidence of drug accumulation. There was indication of clinically meaningful improvement in axillary HH.

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