Method and compound for reducing sensory discomfort

Abstract

A method for reducing sensory discomfort in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject's airways including at least entrance of a patient's nares; the method comprising the steps of: topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject's face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter; wherein the compound, following topical application, penetrates the subject's skin; and thereafter, wearing the mask for prolonged periods of time to cover the subject's mouth and nostrils.

Description

METHOD AND COMPOUND FOR REDUCING SENSORY DISCOMFORTTECHNICAL FIELD

[0001] The present invention relates to methods and compounds for reducing sensory discomfort and other skin conditions caused due to use of sleep apnea masks over prolonged periods.BACKGROUND

[0002] Any references to methods, apparatus or documents of the prior art are not to be taken as constituting any evidence or admission that they formed, or form part of the common general knowledge.

[0003] About half of people prescribed continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) either stop using the treatment, or don't use it as often as recommended. One reason a person might stop using a CPAP machine is because they may develop skin issues, including but not limited to contact dermatitis.

[0004] Contact dermatitis is a type of sensory discomfort which is caused due to skin inflammation results from the skin being in contact with something that irritates it or provokes an allergic reaction. When a person has contact dermatitis, their skin may turn red, itch, burn, swell, blister, or crack. Whilst dermatitis may be temporarily resolved using topical steroids, prolonged use of such ointments can lead to thinning of the patient’s skin and long term steroid dependence.

[0005] Skin irritation or demulcent skin presentation upon wearing CPAP masks or even other marks can be due to: constant pressure from a mask (contact dermatitis); constant air flowing over the skin; friction from the mask or objects moving up and down over the skin (face I head I neck I behind ears etc) build up of swear underneath the mask creating a moist and bacteria-prone environment In a person who has developed contact dermatitis in response to prolonged wearing of masks such as CPAP masks, these effects mostly occur near wherever the mask touches the skin, such as the nose, mouth, or face. Therefore, it would be desirable to find a method for reducing sensory discomfort and other skin conditions associated with the use of masks.SUMMARY OF INVENTION

[0006] In an aspect, there is provided a method for reducing sensory discomfort in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares; the method comprising the steps of:topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject’s face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter;wherein the compound, following topical application, penetrates the subject’s skin; and thereafter, wearing the mask for prolonged periods of time to cover the subject’s mouth and nostrils.

[0007] In another aspect, there is provided a method for preventing skin dermatitis in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares; the method comprising the steps of:topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject’s face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter;wherein the compound, following topical application, penetrates the subject’s skin; and thereafter, wearing the mask for prolonged periods of time to cover the subject’s mouth and / or nostrils.

[0008] In yet another aspect, there is provided a compound suitable for topical application for reducing sensory discomfort in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares, the compound comprising: less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter.

[0009] In an embodiment, the therapeutically effective compound comprises zinc oxide in the range of 5wt% and 10wt%.

[0010] In an embodiment, the therapeutically effective compound further comprises at least 5wt% glycerol.

[0011] In an embodiment, the therapeutically effective compound comprises glycerol in the range of 5wt% and 15wt%.

[0012] In an embodiment, the therapeutically effective compound comprises shea butter in the range of 2wt% to 7.5wt% and more preferably 2wt% to 5wt%.

[0013] In an embodiment, the excipient further comprises a lipid in the range of 2wt% to 5wt%, the lipid being chosen from a group comprising one or more of castor seed oil, hydrogenated castor oil, Copernicia cerifera wax, bees wax.

[0014] In an embodiment, the excipient comprises less than 5wt% and more preferably less than 3wt% polyglyceryl-2 Dipolyhydroxystereate.

[0015] In an embodiment, the excipient comprises stearic acid in the range of 2.5wt% and 5wt%.

[0016] In an embodiment, the excipient comprises an emulsifier in the range of 5wt% and 10wt%.

[0017] In an embodiment, the emulsifier comprises one or more of: Cetearyl alcohol and PEG-20 Stearate.

[0018] In an embodiment, the excipient comprises an emulsion stabilizer in the range of 2.5wt% to 5wt%.

[0019] In an embodiment, the emulsion stabilizer comprises stearic acid.

[0020] In an embodiment, the excipient further comprises less than 3wt% preservatives and wherein the preservatives are preferably chosen from Geogard® 221, dihydroacetic acid and benzyl alcohol.

[0021] In an embodiment, the excipients further comprise one or more emulsifying surfactants in amount of 2.5wt% to 5wt%.DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0022] Provided herein are methods and compounds for reducing the possibility of sensory discomfort as a result of skin conditions such as but not limited to dermatitis when a subject uses a CPAP mask for prolonged periods.

[0023] In a first preferred embodiment, the compound was prepared in the following manner. An amount of at least 5wt% zinc oxide was combined with the oil phase ingredients in amounts as shown in Table 1 and the mixture was heated to 80 degrees Celcius. The oil phase ingredients include • Vegepetroleum (or equivalent) Ricinus Communis Seed Oil, Hydrogenated Castor oil, Copernicia Cerifera Wax, Beeswax, Shea Butter, Cetearyl alcohol, PEG-20 Stearate, Stearic acid, Tocopherol, Polyglyceryl-2 Dipolyhydroxystearate, Isopropyl Myristate and Sorbitan Oleate.

[0024] The second step involved combining the water phase ingredients including water, calendula extract, glycerol and sodium PCA and heated to 80 degrees Celsius.TABLE 1& &>& &> "

[0025] The third step involves homogenising the two phases together and undertake stirring of the mixture while cooling. When the homogenised mixture reaches a temperature of 40 degrees C or less Geogard 221 may be added. At this stage the preservative is stirred in. Cooling and stirring are continued until the emulsion is at room temperature.

[0026] In further examples, two other exemplary formulations were prepared in accordance with further embodiments. The inventors conducted extensive experiments and trials to vary the amount of zinc oxide and increasing or adding another active ingredient namely shea butter. These additional formulations are denoted by Formula 1 and Formula 2 in Table 2 below.TABLE 2< < " < > & >< < > & < >

[0027] The inventors believe that the Zinc oxide, calendula officinalis flower liquid extract (50mg / g) eq to fresh (50mg / g) and in some instances the shea butter constitute the active ingredients. It is hypothesized that the formulation forms a gentle barrier cream that helps to protect sensory irritation while the CPAP mask is worn by the subject over prolonged periods. It is also hypothesized that the formulation reduces skin sensitivity and relieves minor abrasions or red rash skin associated with prolonged wearing of CPAP masks. Some of the non-limiting benefits of the formulation are as follows:• Decrease / reduce / relieve skin irritation• Soothe / relieve skin inflammation• Reduce occurrence of skin chafing• Relieve minor skin eruptions• Relieve mild tissue oedema• Anti-inflammatory / relieve inflammation• Antioxidant / Reduce free radicals formed in the body• Enhance / improve / promote skin repair / healing• Maintain / support skin health• Decrease / reduce skin sensitivity• Relieve red skin rash• Decrease / reduce / relieve skin redness

[0028] The following protocol was followed to conduct preliminary trials for the formulations. These trials were carried out over 30 days and involved 100 patients at Princess Alexandra Hospital. The goal was to evaluate effectiveness of a preparatory step for oxygen therapy in preventing mask related injuries and improving therapy compliance.

[0029] The patients were provided masks with soft flexible materials with improved pressure distribution and adjustable straps. The key primary outcomes being monitored included recording incidents of mask-related injuries (eg. skin breakdown, pressure ulcers), patient comfort scores and therapy compliance rates.Results:1. Mask-related injuries:90% reduction in the incidence of skin breakdown and pressure ulcers compared to historical data with standard masks.2. Patient comfort:Mean comfort score of 8.5 / 10, significantly higher than the 6 / 10 reported with standard masks3. Therapy compliance:95% of patients maintained prescribed oxygen therapy throughout the study period, compared to a historical compliance rate of 75%Secondary Outcomes:1. No adverse reactions reported related to the formulation.2. 85% of patients reported reduced discomfort and irritation symptoms3. Oxygen therapy continuation rate increased by 25% compared to historical data Conclusion:

[0030] The formulation demonstrated significant improvements in preventing mask-related injuries, enhancing patient comfort, and increasing therapy compliance. These positive outcomes were achieved without any reported adverse reactions, suggesting that the formulation could be a valuable tool in improving the overall quality of oxygen therapy delivery and patient experience.Implications:Topical application of the formulation could lead to:• Reduced incidence of treatment interruptions due to mask-related complications • Improved patient outcomes through consistent oxygen therapy• Potential cost savings from reduced treatment of mask-related injuries.

[0031] The formulation was also compared with some of the currently known alternative formulations known in the prior art. In comparison with the alternative prior art formulations of Vaseline and Paw Paw cream, the formulation of the currentembodiment provides a non-greasy alternative that does not interfere with the mask seal and is rapidly absorbed by the subject’s skin.Clinical Outcomes:• 82% reduction in skin irritation• 94% therapy compliance rate• Significant improvement in patient comfort• No reported serious adverse reactions• No adverse consequences of inhalation

[0032] The comparison demonstrates that while Vaseline, Paw Paw and Bepanthen ointment may provide basic moisture barrier properties, they lack the comprehensive therapeutic benefits and specific design features of the presently described subject formulation, which has been purposefully developed and clinically proven for preventing and treating mask-related skin injuries.

[0033] The inventors have also developed a specific method of administering or delivering the compound to users of the CPAP mask. The inventors have discovered that the step of applying an effective amount of the aforementioned formulation along specific parts of the subject’s face is important. In one method embodiment, the formulation may be applied only along specific regions or pressure points that would be anticipated to be in direct contact with the user’s skin. These regions may be discrete regions on the user’s face. Once these regions are identified, the next step involves applying the formulation to these regions of the face before applying the mask over the user’s face to cover the user’s face, nose and nostrils.

[0034] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. The term “comprises” and its variations, such as “comprising” and “comprised of” is used throughout in an inclusive sense and not to the exclusion of any additional features.

[0035] It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect.

[0036] The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art.

Claims

CLAIMS1. A method for reducing sensory discomfort in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares; the method comprising the steps of: topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject’s face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter;wherein the compound, following topical application, penetrates the subject’s skin; andthereafter, wearing the mask for prolonged periods of time to cover the subject’s mouth and / or nostrils.

2. A method in accordance with claim 1 wherein the therapeutically effective compound comprises zinc oxide in the range of 5wt% and 10wt%.

3. A method in accordance with claim 1 or claim 2 wherein the therapeutically effective compound further comprises at least 5wt% glycerol.

4. A method in accordance with any one of the preceding claims wherein the therapeutically effective compound comprises glycerol in the range of 5wt% and 15wt%.

5. A method in accordance with any one of the preceding claims wherein the therapeutically effective compound comprises shea butter in the range of 2wt% to 7.5wt% and more preferably 2wt% to 5wt%.

6. A method in accordance with any one of the preceding claims wherein the excipient further comprises a lipid in the range of 2wt% to 5wt%, the lipid being chosen from a group comprising one or more of castor seed oil, hydrogenated castor oil, Copernicia cerifera wax, bees wax.

7. A method in accordance with any one of the preceding claims wherein the excipient comprises less than 5wt% and more preferably less than 3wt% polyglyceryl-2 Dipolyhydroxystereate.

8. A method in accordance with any one of the preceding claims wherein the excipient comprises stearic acid in the range of 2.5wt% and 5wt%.

9. A method in accordance with any one of the preceding claims wherein the excipient comprises an emulsifier in the range of 5wt% and 10wt%.

10. A method in accordance with claim 9 wherein the emulsifier comprises one or more of: Cetearyl alcohol and PEG-20 Stearate.

11. A method in accordance with any one of the preceding claims wherein the excipient comprises an emulsion stabilizer in the range of 2.5wt% to 5wt%.

12. A method in accordance with claim 11 wherein the emulsion stabilizer comprises stearic acid.

13. A method in accordance with any one of the preceding claims wherein the excipient further comprises less than 3wt% preservatives and wherein the preservatives are preferably chosen from Geogard® 221, dihydroacetic acid and benzyl alcohol.

14. A method in accordance with any one of the preceding claims wherein the excipients further comprise one or more emulsifying surfactants in amount of 2.5wt% to 5wt%.

15. A method for preventing skin dermatitis in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares; the method comprising the steps of: topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject’s face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter;wherein the compound, following topical application, penetrates the subject’s skin; andthereafter, wearing the mask for prolonged periods of time to cover the subject’s mouth and nostrils.

16. A compound suitable for topical application for reducing sensory discomfort in a subject caused by wearing a mask for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the subject’s airways including at least entrance of a patient's nares, the compound comprising: less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter.

17. A compound in accordance with claim 16 wherein the therapeutically effective compound comprises zinc oxide in the range of 5wt% and 10wt%.

18. A compound in accordance with claim 16 or claim 17 wherein the therapeutically effective compound further comprises at least 5wt% glycerol.

19. A compound in accordance with any one of claims 16 or 17 wherein the therapeutically effective compound comprises glycerol in the range of 5wt% and 15wt%.

20. A compound in accordance with any one of claims 16 to 19 wherein the therapeutically effective compound comprises shea butter in the range of 2wt% to 7.5wt% and more preferably 2wt% to 5wt%.

21. A compound in accordance with any one of claims 16 to 20 wherein the excipient further comprises a lipid in the range of 2wt% to 5wt%, the lipid being chosen from a group comprising one or more of castor seed oil, hydrogenated castor oil, Copernicia cerifera wax, bees wax.

22. A compound in accordance with any one of claims 16 to 21 wherein the excipient comprises less than 5wt% and more preferably less than 3wt% polyglyceryl-2 Dipolyhydroxystereate.

23. A compound in accordance with any one of claims 16 to 22 wherein the excipient comprises stearic acid in the range of 2.5wt% and 5wt%.

24. A compound in accordance with any one of claims 16 to 23 wherein the excipient comprises an emulsifier in the range of 5wt% and 10wt%.

25. A compound in accordance with claim 24 wherein the emulsifier comprises one or more of: Cetearyl alcohol and PEG-20 Stearate.

26. A compound in accordance with any one of claims 16 to 25 wherein the excipient comprises an emulsion stabilizer in the range of 2.5wt% to 5wt%.

27. A compound in accordance with claim 26 wherein the emulsion stabilizer comprises stearic acid.

28. A compound in accordance with claims 16 to 27 wherein the excipient further comprises less than 3wt% preservatives and wherein the preservatives are preferably chosen from Geogard® 221, dihydroacetic acid and benzyl alcohol.

29. A compound in accordance with any one of claims 16 to 28 wherein the excipients further comprise one or more emulsifying surfactants in amount of 2.5wt% to 5wt%.

30. A method for reducing sensory discomfort in a subject caused by wearing a mask; the method comprising the steps of:topically applying a liquid or semi-liquid or semi-solid composition to the skin of the subject’s face being covered by the mask, the composition comprising less than 90 wt% excipient and less than 15wt% of therapeutically effective compound and wherein the therapeutically effective compound further comprises at least 5wt% zinc oxide; at least 5wt% calendula extract; and at least 2wt% shea butter;wherein the compound, following topical application, penetrates the subject’s skin; andthereafter, wearing the mask for prolonged periods of time to cover the subject’s mouth and / or nostrils.

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