Patient Stratification for Botulinum Toxin Efficacy

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Solution Overview

Problem

Current treatments for skin conditions like acne and hyperhidrosis often fail to provide effective results due to the assumption that patients respond proportionally to treatment based on disease severity, leading to inconsistent outcomes across different patient populations.

Innovation Solution

The method involves stratifying patients into categories based on disease severity and administering treatments, such as botulinum toxin, specifically to those in the more severe category, where the treatment is likely to be most effective, thereby optimizing therapeutic benefit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If treatment is administered to all patients regardless of disease severity, then treatment coverage is maximized, but treatment effectiveness is reduced due to proportional response assumption

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidtreatment coverage
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent segments the patient population into distinct groups based on disease severity (mild, moderate, severe). This segmentation allows the treatment to be targeted specifically at severe patients, improving treatment effectiveness for this group while acknowledging that mild patients may not benefit proportionally from the same dosage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by providing different treatment approaches to different patient segments. Severe patients receive the full treatment dosage, while mild patients may receive reduced dosage or alternative treatments, optimizing the quality of treatment for each specific patient group rather than applying a uniform approach.

Inventive Principle:
Principle #3Local quality

2Reliability

If uniform dosage is administered to all patients, then treatment simplicity is maintained, but inconsistent outcomes occur across different disease severity levels

Engineering Contradiction:
Improvetreatment outcome consistencyVSAvoidtreatment protocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces dynamic dosing where the treatment dosage is adjusted based on the patient's disease severity level. This dynamic approach ensures consistent treatment outcomes across different patient groups by adapting the dosage to match the severity, rather than using a static uniform dosage for all patients.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the dosage parameter based on disease severity classification. By modifying this key treatment parameter according to patient needs, the patent achieves consistent treatment outcomes while systematically managing the complexity through defined severity categories and corresponding dosage protocols.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If treatment is targeted only to severe patients, then resource efficiency is improved, but treatment accessibility to mild patients is reduced

Engineering Contradiction:
Improveresource efficiencyVSAvoidtreatment accessibility
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The patent applies partial action by providing treatment primarily to severe patients who need it most, while offering reduced or alternative treatments to mild patients. This ensures resource efficiency by concentrating full treatment on those with greatest need, while still maintaining accessibility for mild cases through scaled-back options.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentUS10485855B2Demonstrable efficacy across or within patient populations
Publication Date: 2019.11.26 ANTERIOS INC
  • US10485855B2 patent drawing
  • US10485855B2 patent drawing
  • US10485855B2 patent drawing

AI summary

The present invention provides methods for improving observed or determined efficacy by administration of agents to more severely diseased subjects, as contrasted with less severely diseased subjects. The present disclosure specifically demonstrates that, with respect to treatment of certain skin conditions, and particularly conditions associated with dysregulated and/or diseased skin cells, administration to more severely diseased subjects improves observed or determined efficacy.