EP-4734958-A1 - TOPICAL COMPOSITION FOR PAIN RELIEF

EP4734958A1EP 4734958 A1EP4734958 A1EP 4734958A1EP-4734958-A1

Abstract

The present invention provides a topical composition including a topical analgesic, a viscosity increasing agent, a humectant, an emollient, and an emulsifier. The topical composition is substantially free of volatile alcohol. Additionally, the present invention includes methods of relieving pain. The methods include topically applying to an exterior skin portion of the user's body in need of pain treatment a composition including a topical analgesic, a viscosity increasing agent, a humectant, an emollient, and an emulsifier.

Inventors

SMALL, ELEANOR F.
CRUDDEN, Edward
SUDER, Austin Courtney
HANNUM, MACKENZIE

Assignees

Kenvue Brands LLC

Dates

Publication Date: 20260506
Application Date: 20240624

Claims (1)

We claim: 1) A topical composition comprising: a topical analgesic, a viscosity increasing agent in an amount of from about 0.05 to about 1.2 wt%, a humectant in an amount of from about 1.0 to about 5.0 wt%, an emollient in an amount of from about 2.5 to about 5.0 wt%, and an emulsifier in an amount of from about 0.5 to about 2.0 wt%, wherein the topical composition is substantially free of volatile alcohol. 2) The topical composition of claim 1, wherein the topical analgesic is in an amount of from about 0.5% to about 10% by weight. 3) The topical composition of claim 1, wherein the topical analgesic comprises one or more of lidocaine, camphor, menthol or benzocaine. 4) The topical composition of claim 3, wherein the topical analgesic comprises lidocaine. 5) The topical composition of claim 4, wherein the lidocaine is in an amount of about 4% by weight. 6) The topical composition of claim 3, wherein the topical analgesic comprises camphor and menthol. 7) The topical composition of claim 6, wherein the camphor is in an amount of about 4% by weight and the menthol is in an amount of about 1.25% by weight. 8) The topical composition of claim 1 , further comprising a cooling agent. 9) The topical composition of claim 8, wherein the cooling agent comprises menthol or menthol lactate. 10) The topical composition of claim 1, further comprising a warming agent. 11) The topical composition of claim 10, wherein the warming agent comprises camphor, vanilla butyl ether or other vanilloid. 12) The topical composition of claim 11, wherein the warming agent comprises vanilla butyl ether or other vanilloid in an amount of about 0.25 to about 0.5% by weight. 13) The topical composition of claim 1, further comprising a warming agent and a cooling agent. 14) The topical composition of claim 13, wherein the warming agent comprises one or more of camphor, vanilla butyl ether or other vanilloid. 15) The topical composition of claim 13, wherein the cooling agent comprises menthol or menthol lactate. 16) The topical composition of claim 13, wherein the warming agent comprises camphor and the cooling agent comprises menthol. 17) The topical composition of claim 16, wherein the camphor and the menthol are in a weight ratio of 3.2: 1. 18) The topical composition of claim 16, wherein the warming agent further comprises vanilla butyl ether. 19) The topical composition of claim 1, wherein the topical composition is free of a cooling agent or a warming agent. 20) The topical composition of claim 1 , wherein the topical composition is free of lidocaine. 21) The topical composition of claim 1, wherein the topical composition is free of menthol. 22) The topical composition of claim 1 , wherein the topical composition is free of camphor. 23) The topical composition of claim 1 , wherein the viscosity increasing agent is in an amount of about 0.6% by weight. 24) The topical composition of claim 1, wherein the humectant is in an amount of about 3.0% by weight. 25) The topical composition of claim 1 , wherein the at least one emollient is in an amount of about 3.5% by weight. 26) The topical composition of claim 1, wherein the emulsifier is in an amount of about 1.0% by weight. 27) A method of relieving pain in a user with sensitive skin, comprising applying the topical composition of claim 1 to an exterior skin portion of the user’ s body in need of pain treatment. 28) The method of claim 27, wherein the exterior skin portion of the user’s body is at least one of the user’s neck, back, legs, hands, fingers and wrists.

Description

TOPICAL COMPOSITION FOR PAIN RELIEF CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of US provision application 63/510760 filed on June 28, 2023, the complete disclosure of which is hereby incorporated herein by reference for all purposes. FIELD OF THE INVENTION [0002] The present invention relates to topical compositions for pain relief; in particular, for pain relief of users with varying skin sensitivities and/or preferences for sensations on the skin that may indicate pain relief. More specifically, the present invention relates to a topical composition including a topical analgesic, as well as at least one viscosity increasing agent, at least one humectant, at least one emollient and at least one emulsifier, where the composition is substantially free of volatile alcohol. [0003] Additionally, the present invention relates to methods of relieving pain, especially in users with sensitive skin and/or in users who prefer certain sensations for pain relief. In particular, such methods include topically applying to an exterior skin portion of a user’s body a composition including a topical analgesic, as well as at least one viscosity increasing agent, at least one humectant, at least one emollient and at least one emulsifier, where the composition is substantially free of volatile alcohol. BACKGROUND OF THE INVENTION [0004] Pain is a common experience that may be of short duration (called “acute pain”) or of longer duration, for example, six months or longer (called “chronic pain”). Pain may negatively impact a person’s quality of life and treatment of pain may be costly. Pain treatment options that are effective and inexpensive are desirable. [0005] Body pain is often treated with a topical pain cream. Topical pain creams currently exist in various forms on the consumer market. However, such creams often provide a harsh user experience causing dry, red, irritated skin, an overly strong cooling or warming sensation and/or an overwhelming scent. Such creams are unsuitable for consumers with sensitive skin. [0006] “Sensitive skin” is defined as the skin of any part of the body that has discomfort at any given time. Examples of conditions causing sensitive skin may include, but are not limited to, acne, contact dermatitis, dry skin, itchy skin and eczema. Sensitive skin may be described as skin that is “reactive” to external stimuli or that presents a special need. Examples of external stimuli may include sunlight, wind, water, air temperature, air moisture, skin and body hydration, diet and/or contact with chemical or physical materials. [0007] Consumers with sensitive skin often find it difficult to find topical cosmetic or medicinal products that do not irritate or further irritate their skin. This is particularly detrimental to sensitive skin consumers who have health or cosmetic concerns (i.e., concerns unrelated to their sensitive skin) that are commonly addressed by topical skin treatments. One such example may be sensitive skin consumers who also suffer from body pain, for example pain in the neck, forearm, elbow, upper arm, wrist, calf, thigh, knee, back, shoulder, hip and/or ankle. [0008] A ’’sensate” in a topical cosmetic or medicinal product is defined as an ingredient that imparts a sensation to the user upon contact. The sensation may start immediately upon contact with the sensate or the sensation may be delayed for a certain period of time. The sensation may be, for example, a warming or a cooling sensation. [0009] Sensates in topical products may cause skin sensitivity. Patients that are sensitive to warming agents have sensitivity to warming, described as too intense, too hot or contributing a burning sensation. Likewise, some patients that are sensitive to cooling agents have sensitivity to cooling, described as too intense, too cold or contributing to numbness of the skin. When a consumer or patient experiences skin sensitivity or a negative sensation while using a topical product, that consumer or patient will be unlikely or reluctant to try that topical product again regardless of whether the product was effective in pain relief. [0010] Additionally, not all consumers and patients are alike. Cooling and warming perception of a patient correlates to the interaction of the topical product with the patient’s nerves and the number of nerves in the patient’s skin. A square inch of human skin has approximately 1,300 pain receptors, where approximately 40 pain receptors per square inch are for cold and approximately six pain receptors per square inch are for warmth. Based on differences in the skin, each patient and consumer may experience skin sensitivity and sensation differently. Therefore, a topical pain product may cause skin sensitivity to one person, but not to another. Likewise, a topical pain product with a sensate may cause a positive sensation, a negative sensation or no sensation depending on the user. [0011] As such, there exists a need for topi