Topical composition for acne treatment

A topical composition combining Moringa oleifera and Salix alba extracts effectively treats acne by reducing acne density and inhibiting Staphylococcus epidermidis, addressing the limitations of current treatments.

WO2025058574A1PCT designated stage expired Publication Date: 2025-03-20ALPINIA INSTITUTE SAGLIK URUNLERI TICARET LTD SIRKETI
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Patent Information

Application Number
PCT/TR2023/050941
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-09-12
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Current treatments for acne often come with side effects and may not be as effective as desired, particularly in minimizing inflammation and addressing the role of Staphylococcus epidermidis in acne severity.

Method used

A topical composition combining Moringa oleifera extract and Salix alba extract, with a weight ratio of 2:1 to 4:1, is developed for acne treatment. The composition includes emulsifiers, thickeners, moisturizers, and preservatives, and is preferably in the form of a cream, foam, gel, lotion, or ointment.

Benefits of technology

The composition demonstrates significant reduction in acne density as measured by the Global Acne Grading Scores, with a 68.49% decrease in acne density observed in a 2-week study, and shows higher inhibition areas against Staphylococcus epidermidis compared to using either extract alone.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to herbal topical compositions for use in the treatment of acne and to a process for preparing such compositions. In the composition of the invention, the weight ratio of Moringa oleifera extract: Salix alba extract is preferably between 2:1 and 4:1, respectively.
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Description

[0001] TOPICAL COMPOSITION FOR ACNE TREATMENT

[0002] Field of the Invention

[0003] This invention relates to herbal topical compositions for use in the treatment of acne and to a process for preparing such compositions. In the composition of the invention, the weight ratio of Moringa oleifera extract: Salix alba extract is preferably between 2:1 and 4:1 , respectively.

[0004] Prior Art

[0005] Acne vulgaris, popularly known as acne, is a multifactorial disease that affects the pilosebaceous follicle and is characterized by comedones, papules, pustules, nodules and scars. As the most common dermatosis in adolescence, it can be considered as a physiological manifestation of puberty (Healy, Eugene, and Nick Simpson. "Acne vulgaris." BMJ: British Medical Journal 308.6932 (1994): 831.).

[0006] Acne vulgaris is a very common cutaneous inflammatory condition. More than 85% of teenagers are affected and it can be a condition that persists into adulthood.

[0007] This high prevalence of acne vulgaris is associated with many conditions such as diet, medications, occupational factors, cosmetic products, climatic factors, psychosocial factors, and lifestyle. All these exposure factors act on the natural skin barrier and microorganisms, causing hyperseborrhea, altered keratinization of the skin, pilosebaceous duct, loss of skin microbial diversity, and inflammation.

[0008] These factors interact, resulting in a chronic inflammatory response localized in the pilosebaceous units (Shan, X., Choi, J. H., Kim, K. J., Lee, Y. J., Ryu, Y. H., Lee, S. J., Moon, S. H., & Rhie, J. W. (2018). Adipose Stem Cells with Conditioned Media for Treatment of Acne Vulgaris Scar. Tissue Engineering and Regenerative Medicine, 15(1 ), 49-61.).

[0009] Acne occurs in the centrofacial areas of the back, upper body and deltoid region. The three main components of acne vulgaris are; comedones, inflammatory lesions, and scarring.

[0010] In scientific studies and clinical practice, scales staging acne severity are needed to evaluate the efficacy of treatment in acne and to follow-up patients. Approaches to assess disease severity in acne can be grouped as determining the number of lesions, global acne severity grading, quality of life scales, and advanced imaging technologies.

[0011] Global acne severity grading is a holistic assessment of acne severity by comparing lesions with text descriptions or photographs. Global staging is advantageous in that it is simple and fast to perform, takes into account the types and sizes of lesions, and skin inflammation, and allows the clinician to monitor predominant lesions (Aksoy, Uzm Dr Hasan, and Meltem Onder. "Aknede §iddet Degerlendirmesi." TURKDERM-Turkish Archives of Dermatology and Venereology 54.Supp: 1 (2020): 16-19.).

[0012] The following table is used in the Global Acne Grading System developed by Doshi et al. :

[0013] The Global Acne Grading System (GAGS) evaluates the face as 6 distinct regions. A factor reflecting the surface area, distribution and pilosebaceous unit density for each anatomical region and a coefficient indicating severity for each lesion type were determined. If there is more than one lesion type in the anatomical region, the coefficient selection is determined by the greatest one (Doshi A, Zaheer A, Stiller MJ: A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol 1997; 36:416-8).

[0014] Follicular keratin ization, seborrhea, and colonization of Propionibacterium acnes / Cutibacterium acnes and Staphylococcus epidermidis (P. Acnes / C. Acnes) in the pilosebaceous unit are central to the development of lesions (Healy, Eugene, and Nick Simpson. "Acne vulgaris." BMJ: British Medical Journal 308.6932 (1994): 831.).

[0015] C. acnes has been identified as one of the main triggers of acne. However, increasing knowledge of the human skin microbiome raises questions about the role of other skin commensals, such as Staphylococcus epidermidis, in the pathophysiology of this skin disease.

[0016] Dysbiosis in acne patients is associated with decreased S. epidermidis count and overcolonization in the sebaceous unit by selected C. acnes phylotypes. This leads to different levels of activation of innate immunity, resulting in different levels of inflammatory acne severity (Claudel, Jean-Paul, et. Al. “Staphylococcus epidermidis: a potential new player in the physiopathology of acne?” Dermatology 235.4 (2019): 287-294).

[0017] Topical retinoids, topical antimicrobials, systemic antibiotics, hormonal therapy and oral isotretinoin are used in the treatment of acne.

[0018] Topical retinoids are the first choice in comedonal acne, used in combination with topical and / or systemic antimicrobial drugs in mild to moderate acne, and used for maintenance therapy when lesions heal. Topical and systemic antibiotics are used in moderate inflammatory acne, they should not be used alone, they should be used together with topical benzoyl peroxide or retinoids and should be discontinued as soon as possible.

[0019] Hormonal therapy is an option for women seeking oral contraception, but may also be used in women with severe seborrhea, late-onset acne, and proven hyperandrogenism.

[0020] Oral isotretinoin acts on four main pathophysiological factors of acne (increased sebum secretion, abnormal follicular desquamation, P. acnes colonization and inflammation) and is the main treatment modality in severe acne. The effectiveness of acne treatment and patient compliance can be increased by many general strategies (Gungor, Emel. "Akne." Turkish Journal of Dermatology / Turk Dermatoloji Dergisis 6.4 (2012).).

[0021] Herbal treatments such as tea tree oil, echinacea extract, eucalyptus and green tea extract are also used in acne treatment. However, these alternative treatment methods are usually not as successful as medications.

[0022] Moringa plant (Moringa oleifera Lam) is a type of medicinal Indian plant that is also common in tropical and subtropical countries. Another name of the plant known for its health benefits is the miracle tree. Since it is a plant used in many fields such as food and cosmetics, various studies have been carried out on different parts of the plant in order to isolate the bioactive substances in its content.

[0023] The most used parts of the plant; leaves rich in vitamins, carotenoids, polyphenols, phenolic acids, flavonoids, alkaloids, glucosinolates, isothiocyanates, tannins and saponins. The high number of bioactive compounds in its content confirms the pharmacological properties of the plant in in-vivo and in-vitro studies.

[0024] As a result of many studies, it has been seen that the Moringa plant has anti-bacterial, anti-inflammatory, anti-spasmodic, anti-hypertensive, anti-oxidant, anti-pyretic effects (Razis, AF Abdull, Muhammad Din Ibrahim, and Saie Brindha Kntayya. "Health benefits of Moringa oleifera." Asian pac J cancer prev 15.20 (2014): 8571 -8576.). Therefore, Moringa oleifera extracts shed a light on scientists that they can be used as an alternative in the treatment of many diseases.

[0025] Especially the leaves of Moringa oleifera contain high amounts of phenolic acids and flavodis. The main flavonoids have been reported as Rutin, Quercetin and Kaempferol (Vergara-Jimenez, Marcela, Manal Mused Almatrafi, and Maria Luz Fernandez. "Bioactive components in Moringa oleifera leaves protect against chronic disease." Antioxidants 6.4 (2017): 91 .).

[0026] Rutin Quercetin Kaempferol

[0027] White willow (Salix alba L.) is a willow species belonging to the genus salix and the family salicaeae. Willows can range in height from shrubs to large trees over 30 m. However, many are in the form of shrubs or small trees. White willow, also known as salicin willow, has been used by humanity for its healthy benefits for thousands of years (Sailer, Reinhard, Jorg Melzer, and Markus Felder. "Pain relief with a proprietary extract of Willow bark in rheumatology. An Open Trial." Schweizerische Zeitschrift fur Ganzheitsmedizin / Swiss Journal of Integrative Medicine 20.3 (2008): 156-162.). Salix alba bark extract is widely used for conditions associated with pain, inflammation, or fever, such as joint or knee pain, acute back pain, osteoarthritis, and general pain. These pharmacological properties of Salix alba bark extract are thought to be related to the content of salicin, a salicylate glycoside. Salicin is also the precursor of acetylsalicylic acid, the active ingredient of many anti-inflammatory drugs.

[0028] A HPLC mass spectrometry analysis of aqueous extracts of Salix alba bark was performed and showed the presence of at least 1 1 related salicylate compounds, including salicin, saligenin, salicylic acid, isosalicin, salidroside, pisein, triandrine, salicoylsalicin, salicortin, isosalipurpuroside, and salipurpuroside.

[0029] The synergistic effect of these related active compounds may be responsible for the antiinflammatory, analgesic and anti-pyretic effects often attributed to salicin (Shara, Mohd, and Sidney J. Stohs. "Efficacy and safety of white willow bark (Salix alba) extracts." Phytotherapy Research 29.8 (2015): 1 1 12-1 116.).

[0030] Salicin Salicylic Acid

[0031] Different extraction methods are used to isolate pharmacologically active compounds found in plants from plants. These include traditional extraction methods such as soxhlet extraction, maceration and percolation, as well as modern extraction methods such as microwave-assisted extraction, extraction with supercritical liquids or extraction methods assisted by ultrasonic waves.

[0032] The extraction process to be chosen differs according to the final product desired to be obtained from the plant. However, in the most general sense, as it is applied in medicinal and aromatic plants, extraction is the process of extracting the soluble substances in the herbal material through this solvent by passing a solvent through the material to be extracted. This method is called the maceration method.

[0033] Antimicrobial susceptibility tests are methods used to determine the effect of an antimicrobial agent on a certain microorganism species in-vitro. While researching the antimicrobial effects of plants, laboratory culture media are used, and different methods such as turbidimetric methods, measurement of inhibition zones, determination of biomass weights, and microorganism counts can be used. However, antimicrobial activity is evaluated by determining MIC (Minimum Inhibitory Concentrations) as in other antimicrobial compounds (Nychas, G. J. E., P. N. Skandamis, and C. C. Tassou. "Antimicrobials from herbs and spices." Natural antimicrobials for the minimal processing of foods (2003): 176-200.).

[0034] The lowest concentration tested at different concentrations and at which the microbial growth of the antimicrobial component completely stops is defined as the Minimum Inhibitory Concentration (MIC). Preparation of antimicrobial dilutions in solid agar or broth medium is among the most frequently used methods to determine MIC. The incubation temperature and the amount of inoculum are the most important factors in determining the MIC of an antimicrobial (Kim, Sung-Youn, et al. "Antimicrobial activity of plant extracts against Salmonella Typhimurium, Escherichia coli 0157: H7, and Listeria monocytogenes on fresh lettuce." Journal of food science 76.1 (2011 ): M41 -M46.).

[0035] In the state of the art, studies have been carried out on different compositions containing salix alba bark extract, salicin, different flavonoids and / or 1 ,2-alkanediols. Application EP0801946A2 relates to the cosmetic and / or dermatological use of salicin in the prevention of dirty skin or erythematous skin appearance caused by acne vulgaris, especially inflamed comedones, rash, inflamed skin in the mouth and nose area, herpes labialis, sunburn and mild skin cracks. The concentration of glycosides in the composition is in the range of 0.01 -10% by weight, preferably 0.1 -5% by weight, especially 0.2-2.0% by weight, based on the total weight of the preparations.

[0036] The invention EP3261726B1 describes a cosmetic or dermatological composition for use in the treatment of acne comprising a combination of salicin and herbal extracts titrated in 1 ,2-alkanediols, preferably 1 ,2-decandiol and Salix alba extract.

[0037] Document DE10034328 A1 relates to a cosmetic composition for external application to the skin containing 0.002-8.0% by weight quercetin, 0.002-8.0% by weight routine, 0.002- 8.0% by weight salicin, 0.002-8.0% by weight escin and up to 100% by weight water.

[0038] In the above-mentioned documents, no scoring method on the effect of finished products on acne or data on any studies on patients was found.

[0039] Drugs used in the treatment of acne and usually sold by prescription can have serious side effects, especially when used orally. Herbal treatments such as tea tree oil, eucalyptus, echinacea and green tea extract are also used in acne treatment. However, these alternative treatment methods are usually not as successful as drugs. In addition, no product for acne treatment has been found in Turkey and in the world, consisting of a combination of Moringa oleifera leaf extract and Salix alba bark extract.

[0040] Therefore, in the state of the art, there is a need for herbal cream compositions in which side effects are minimized, effectiveness has been demonstrated by the Global Acne Grading Score method, and the effect on S. epidermidis bacteria has been demonstrated by MIC test.

[0041] Description of the Figures

[0042] Figure 1 . The change in the Global Acne Grading Scores calculated according to the observational studies, depending on the content of the cream used.

[0043] Description of the Invention

[0044] The present invention is a topical composition for use in the treatment of acne comprising Moringa oleifera extract and Salix alba extract.

[0045] In the composition of the present invention, the weight ratio of Moringa oleifera extract: Salix alba extract is preferably between 2:1 and 4:1 , respectively.

[0046] Topical formulations are compositions applied to the skin surface. They can come in a variety of forms, including creams, foams, gels, lotions, and ointments.

[0047] The amount of Moringa oleifera extract in the composition of the invention is preferably between 10-20% by weight. In the most preferred case, it is 15%.

[0048] The amount of Salix alba extract in the composition of the invention is preferably between 1 -10% by weight. Most preferably it is 5%.

[0049] The Moringa oleifera extract in the composition of the invention preferably comprising a minimum of 0.2% by weight of rutin.

[0050] The Salix alba extract in the composition of the present invention preferably comprising salicin at a minimum rate of 2.5% by weight. Another embodiment of the invention is a process for the preparation of Moringa oleifera extract in the composition, wherein the extract is prepared according to the following steps. a. Weighing a fair amount of Moringa oleifera leaves, b. Taking the leaves into a 1 :1 mixture of Vegetable Glycerin: Deionized Water, c. Heating the mixture in step b to 60°C, d. Carrying out the extraction process for 24 hours in the MY-Mak extractor at 120 RPM, which will obtain a phenolic-rich extract designed for Moringa oleifera extraction, e. Waiting for the mixture in step d to reach room temperature, f. Filtering the mixture in step e with the line filter in the extraction system, g. Applying the fractionation process to the mixture in step f, h. Filtration of the mixture in step g through a 200 micron filter.

[0051] Another embodiment of the invention is a process for the preparation of Salix alba extract in the composition, wherein the extract is prepared according to the following steps. a. Weighing and grinding a fair amount of Salix alba bark, b. Taking the grinded barks into a 1 :1 mixture of Ethyl Alcohol: Deionized Water, c. Heating the mixture in step b to 60°C, d. Carrying out a 24-hour extraction process in an extractor, e. Waiting for the mixture in step d to reach room temperature, f. Filtering the mixture in step e with the line filter in the extraction system.

[0052] The composition of the invention preferably comprising one or more emulsifiers. Inutec SL-1 and Glyceryl Monostearate can be used as emulsifiers.

[0053] Inutec SL-1 is a specific emulsifier containing inulin, dodecyl carbamate and glycerin.

[0054] The amount of Inutec SL-1 in the composition is preferably between 5-15% by weight, most preferably 10%. The amount of Glyceryl Monostearate in the composition is preferably between 1 -10% by weight, most preferably 5%. The composition of the invention preferably comprising one or more thickeners. Cetyl Alcohol and Stearyl Alcohol can be used as thickeners.

[0055] In a preferred embodiment, the composition of the invention comprising Cetyl Alcohol and Stearyl Alcohol as thickeners. The amount of Cetyl Alcohol in the composition is preferably between 1 -5% by weight, most preferably 4%. The amount of Stearyl Alcohol in the composition is preferably between 1 -5% by weight, most preferably 4%.

[0056] The composition of the invention comprising one or more bases. Medium Chain Triglyceride can be used as a base.

[0057] In a preferred embodiment, the composition according to the invention comprising Medium Chain Triglyceride as a base. The amount of Medium Chain Triglycerides in the composition is preferably between 10-20% by weight, most preferably 15%.

[0058] The composition of the invention preferably comprising one or more moisturizers. The amount of moisturizer in the composition is preferably between 1 -5% by weight, most preferably 3%. Teqactive (HaB)3 + C can be used as a moisturizer.

[0059] In a preferred embodiment, the composition of the invention comprising Teqactive (HaB)3 + C as a moisturizer. Teqactive (HaB)3 + C is a moisturizer containing Hyaluronic acid, Niacinamide and Collagen.

[0060] The composition of the invention preferably comprising one or more preservatives. The amount of preservative is preferably between 0.1 -3% by weight, most preferably 0.5%. Preferably, Euxyl PE 9010 can be used as a preservative. Euxyl PE 9010 is a preservative containing ethylhexylglycerine and phenoxyethanol. The composition of the invention preferably comprising one or more solvents. Deionized Water can be used as solvent. The amount of Deionized Water in the composition is preferably between 30-45% by weight, most preferably 38%.

[0061] The composition of the invention preferably comprising one or more fragrences. The amount of fragrance in the composition is preferably between 0.1 -3% by weight, most preferably 0.5%. Preferably Olive can be used as fragrance.

[0062] Olive is fragrance containing 10-15% tetrahydro linalool, 8-10% galaxolide, 8-10% fluorosa pyranol, 5-6% hedione and 4-5% verdox by weight.

[0063] One embodiment of the invention is a topical composition for use in the treatment of acne, comprising Moringa oleifera Extract and Salix alba Extract, Inutec SL-1 and Glyceryl Monostearate as emulsifiers, Cetyl Alcohol and Stearyl Alcohol as thickener, Medium Chain Triglyceride as base, Teqactive (HaB)3 + C as moisturizer, Euxyl PE 9010 as preservative, Deionized Water as solvent and Olive as fragrance.

[0064] The composition of the invention may preferably be in the form of a cream, foam, gel, lotion or ointment.

[0065] Another embodiment of the invention is a process for preparing a topical composition for use in the treatment of acne and the composition is being prepared according to the following steps. a. Obtaining phase A by weighing and heating the emulsifier, thickener and base in a container, b. Heating a sufficient amount of solvent in a separate container and mixing it by adding emulsifier, c. After the emulsifier dissolves completely in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it, e. Homogenizing and mixing the C phase, f. Adding Moisturizer, Preservative and Fragrance to phase C respectively and mixing.

[0066] The process of the invention is preferably prepared according to the following steps. a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it, b. Heating a sufficient amount of deionized water in a separate container and adding Inutec SL-1 to it and mixing, c. After the Inutec SL-1 is completely dissolved in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it, e. Homogenizing and mixing phase C, f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively,

[0067] Examples

[0068] Examples of the composition and process of the invention are given below, with the aim of better understanding the invention. It does not limit the subject of the invention.

[0069] The unit formulas for the exemplary cream composition for the composition of the invention are as follows:

[0070] Example 1

[0071] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Example 2

[0072] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Ornek 3

[0073] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Example 4

[0074] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Moringa oleifera and Salix alba extracts and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Example 5

[0075] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Salix alba extract and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Example 6

[0076] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. After the complete dissolution of Inutec SL-1 in step b, adding Moringa oleifera extract and continuing mixing to obtain phase B, d. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, e. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. f. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, g. Packaging of the final composition at room temperature, Example 7

[0077] The process for the above-mentioned unit formula is as follows: a. Obtaining phase A by weighing glyceryl monostearate, cetyl alcohol, stearyl alcohol and medium chain triglyceride in a container and heating it to 70°C, b. Obtaining phase B by heating a sufficient amount of deionized water to 70°C in a separate container and adding Inutec SL-1 to it and mixing, c. Obtaining phase C by adding phase A to phase B and mixing it while both phases at 70°C, d. After both phases are mixed, the C phase should be homogenized at high speed and the temperature should drop below 40°C while mixing. e. Continuing to mix on the C phase which temperature drops below 40°C and mixing by adding Teqactive (HaB)3 + C, Euxyl PE 9010 and Olive respectively, f. Packaging of the final composition at room temperature,

[0078] As can be clearly seen in Figure 1 , at the end of the 2-week observational study, acne density calculated according to the change in Global Acne Grading Scores of Example 2, Example 5, and Example 6 was decreased 68.49%, 29.73%, 15.89%, respectively.

[0079] The results of the Staphylococcus epidermidis Minimum Inhibitory Concentration test for the above-mentioned sample formulations are given table below. 1% Clindamycin was used as control.

[0080] As can be seen in the table, the areas of inhibition are directly proportional to the increasing Moringa oleifera extract concentration of creams.

[0081] Also, it has surprisingly been found that the creams comprising the combination of Salix alba and Moringa oleifera extracts showed a higher inhibition area than the cream comprising Salix alba or Moringa oleifera extract alone.

Claims

CLAIMS1 . A topical composition for use in the treatment of acne, wherein it comprises Moringa oleifera extract and Salix alba extract.

2. A topical composition according to claim 1 , wherein the amount of Moringa oleifera extract in the composition is between 10-20% by weight.

3. A topical composition according to any of the previous claims, wherein the amount of Salix alba extract is between 1 -10% by weight.

4. A topical composition according to any of the previous claims, wherein the weight ratio of Moringa oleifera extract and Salix alba extract is between 2:1 and 4:1 .

5. A topical composition according to any of the previous claims, wherein it is in the form of cream, foam, gel, lotion or ointment.

6. A topical composition according to Claim 5, wherein it is in the form of a cream.

7. A topical composition according to any of the previous claims, wherein the composition comprises Inutec SL-1 and Glyceryl Monostearate as an emulsifier.

8. A topical composition according to claim 7, wherein the amount of Inutec SL-1 in the composition is between 5-15% by weight.

9. A topical composition according to claim 7, wherein the amount of Glyceryl Monostearate in the composition is between 1 -10% by weight.

10. A topical composition according to any of the previous claims, wherein the composition comprises Cetyl Alcohol and Stearyl Alcohol as a thickener.1 1 . A topical composition according to claim 10, wherein the amount of Cetyl Alcohol in the composition is between 1 -5% by weight.

12. A topical composition according to claim 10, wherein the amount of Stearyl Alcohol in the composition is between 1 -5% by weight.

13. A topical composition according to any of the previous claims, wherein the composition comprises Medium Chain Triglycerides as a plaster.

14. A topical composition according to claim 13, wherein the amount of Medium Chain Triglycerides in the composition is between 10-20% by weight.

15. A topical composition according to any of the previous claims, wherein the composition comprises Teqactive (HaB)3 + C as a moisturizer.

16. A topical composition according to claim 15, wherein the amount of Teqactive (HaB)3 + C in the composition is between 1 -5% by weight.

17. A topical composition according to any of the previous claims, wherein the composition comprises Euxyl PE 9010 as a preservative.

18. A topical composition according to claim 17, wherein the amount of Euxyl PE 9010 in the composition is between 0.1 -3% by weight.

19. A topical composition with according to any of the previous claims, wherein the composition comprises Deionized Water as a solvent.

20. A topical composition according to Claim 19, wherein the amount of Deionized Water in the composition is between 30-45% by weight.

21. A topical composition according to any of the previous claims, wherein the composition comprises Olive as an essential oil.

22. A topical composition according to claim 21 , wherein the amount of Olive in the composition is between 0.1 -3% by weight.

Citation Information

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