FIELD OF THE INVENTION

[0001] The present invention relates to a dermal composition and method for synthesis thereof that is capable of treating hard, scaly, velvety dark skin by working on overgrown keratinocytes without changing the skin pH as well as preventing the adverse effects on the skin, thereby improving the skin conditions.

BACKGROUND OF THE INVENTION

[0002] Acanthosis Nigricans is a common skin problem, but it is considered as an orphan disease by the pharmaceutical sector. Therefore, not much work had been done on this condition. Dermatologists had very limited choice of products to treat this condition but still the results were not satisfactory as none of the products were as good to treat this problem. In most cases, multiple product therapy is given which increases the financial burden on patients and incompliance. Lack of scientific support in the previously available products also became a major factor to question the efficacy and safety of the previously available products.

[0003] Conventionally, various ointments and dermal cream are synthesized that are available for treating the darker areas of an individual. However, the application these products over the skin damages the healthy skin, lower the pH of the skin which makes its unsuitable for the sensitive skin. Due to the more deposition of keratinocytes within the darker skin of an individual, the skin of an individual becomes dark due to the moisturizer agent within the cream is fails to penetrate into the skin layers that minimizes the efficacy of the skin as well as causes dryness of the skin. Therefore, there is a need of a solution.

[0004] CN105569635A discloses about a a traditional Chinese medicine formula for treating acanthosis nigricans. The traditional Chinese medicine formula comprises Chinese medicinal herbs including root of shortlobe ligusticum, root of delavay ampelopsis, Chinese alangium root, star-flower lysimachia, oriental bittersweet root, betel pepper leaf, large-leaved uncaria root, Polygonum hydropiper, root of Paliurus ramosissimus, Lindera angustifolia, Pedicularis root, Herba alyxiae sinensis, Chinese box twig, phoenix tree root, stem of many-flower fissistigma, China creeper root, creeping fig root, bodinier beautyberry root and stem and leaf of rauwolfia. Being prepared from pure natural Chinese medicinal herbs, the traditional Chinese medicine formula for treating acanthosis nigricans is capable of treating both symptoms and root causes, exact in treatment effect, free of toxic or side effect and less prone to causing recurrence.

[0005] WO2008078154A2 discloses about an improved skin composition intended for topical application to skin for lightening hyperpigmented skin is provided. The subject composition is characterized by incorporation of at least one carbohydrate-based melanin inhibiting agent selected from bearberry extract, ascorbyl glucoside, rutin and arbutin into an ultralow molecular weight aminoglycan polymer gel. It has been found that the skin composition of the present invention possesses improved skin penetration and significantly enhances the depigmenting effect of the active agents.

[0006] Conventionally, various creams and dermal composition are known that are used to treat darker patches or skin area of an individual, however, due to the presence of steroids, the long term application of these creams causes skin atrophy which is an irreversible damage to the skin.

[0007] In order to overcome the aforementioned drawbacks, there is a need to synthesize a dermal composition that is pH stabilized due to which it does not causes any side effects to the skin. In addition, there is a need to provide a composition that is penetrated deep inside within an individual skin for increasing an efficacy as well for hydrating the individual skin.

OBJECTS OF THE INVENTION

[0008] The principal object of the present invention is to overcome the disadvantages of the prior art.

[0009] An object of the present invention is to synthesize a composition that is capable of treating dark, scaly, velvety dark skin in a safe manner without damaging an individual skin.

[0010] Another object of the present invention is to synthesize a composition that consist of moisturizers with penetration enhancer which penetrates deeply to hydrate the skin as well as for enhancing the efficacy.

[0011] Another object of the present invention is to synthesize a composition that is steroid-free which is safe for all skin types.

[0012] Yet another object of the present invention is to develop a synthesize that is effective and reliable in nature.

[0013] The foregoing and other objects, features, and advantages of the present invention will become readily apparent upon further review of the following detailed description of the preferred embodiment as illustrated in the accompanying drawings.

SUMMARY OF THE INVENTION

[0014] The present invention relates to a dermal composition and method for synthesis thereof which consists of moisturizers along with penetration enhancer which penetrates deeply to hydrate the skin as well as enhances the efficacy for treating hard, velvety and darker skin in a safe manner.

[0015] According to an embodiment of the present invention, a dermal composition comprises of: i) retinol in the range of 2-5%w/w, ii) Aloe vera gel in the range of 3-4%w/w, iii) zinc oxide in the range of 1-2 %w/w, iv) premix-A in the range of 15-20%w/w, v) premix-B in the range of 10-15%w/w, vi) premix-C in the range of 1-2%w/w, vii) Brookswax D in the range of 1-2%w/w, viii) almond oil in the range of 3-8%w/w, ix) Jojoba oil in the range of 1-2%w/w, x) water in the range of 53-58%w/w.

[0016] According to another embodiment of the present invention, a method for synthesis of dermal composition comprises of following steps: i) water is transferred in a water heating tank followed by heating of the water at a temperature in the range of 70-75oC in order to obtain hot water, ii) Brookswax D, almond oil, and Jojoba oil is added in a wax melting tank, followed by heating at a temperature in the range of 70-75oC and stirring for a time duration in the range of 3-8 minutes in order to obtain a solution, iii) the hot water and solution is mixed in a mixing tank through vacuum at a negative pressure in the range of 250-350kg/cm2 under continuous stirring, followed by flushing nitrogen gas in the mixing tank at continuous stirring at a speed in the range of 20-30 RPM (Revolutions Per Minute) for a time duration in the range of 20-40 minutes using homogenizer, in order to obtain an emulsion, iv) the retinol, Aloe vera gel, zinc oxide, premix-A, premix-B, and premix-C is added in the mixing tank at a temperature in the range of 35-40oC followed by stirring at a speed in the range of 20-30 rpm, and homogenization at a speed in the range of 25-350 rpm for a time duration in the range of 10-20 minutes in order to obtain a mixture, and v) Phenoxyethanol and Ethylhexylglycerin is added in the mixture, followed by stirring at speed in the range of 20-25 rpm for a time duration in the range of 3-8 minutes in order to obtain the dermal composition.

[0017] While the invention has been described and shown with particular reference to the preferred embodiment, it will be apparent that variations might be possible that would fall within the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where:
Figure 1 illustrates a pictorial image of an each constituent along with its function;
Figure 2 a graphical representation of total score of efficacy of dermal composition over a treated area (Elbow, neck and knees);
Figure 3 illustrates a graphical representation of Texture of efficacy of dermal composition over a treated area (Elbow, neck and knees); and
Figure 4 illustrates a graphical representation of chromametry of dermal composition over a treated area (Elbow, neck and knees).

DETAILED DESCRIPTION OF THE INVENTION

[0019] The following description includes the preferred best mode of one embodiment of the present invention. It will be clear from this description of the invention that the invention is not limited to these illustrated embodiments but that the invention also includes a variety of modifications and embodiments thereto. Therefore, the present description should be seen as illustrative and not limiting. While the invention is susceptible to various modifications and alternative constructions, it should be understood, that there is no intention to limit the invention to the specific form disclosed, but, on the contrary, the invention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined in the claims.

[0020] In any embodiment described herein, the open-ended terms "comprising," "comprises,” and the like (which are synonymous with "including," "having” and "characterized by") may be replaced by the respective partially closed phrases "consisting essentially of," consists essentially of," and the like or the respective closed phrases "consisting of," "consists of, the like.

[0021] As used herein, the singular forms “a,” “an,” and “the” designate both the singular and the plural, unless expressly stated to designate the singular only.

[0022] The present invention relates to a dermal composition and method for synthesis thereof that is formed by the composition of a wide range of temperature and environmental conditions and is steroid free which is safe for all skin types and does not cause any side effects.

[0023] According to an embodiment of the present invention, a dermal composition comprises of: i) retinol in the range of 2-5%w/w, ii) Aloe vera gel in the range of 3-4%w/w, iii) zinc oxide in the range of 1-2 %w/w, iv) premix-A in the range of 15-20%w/w, v) premix-B in the range of 10-15% w/w, vi) premix-C in the range of 1-2% w/w, vii) Brookswax D in the range of 1-2% w/w, viii) almond oil in the range of 3-8% w/w, ix) Jojoba oil in the range of 1-2%w/w, x) water in the range of 53-58% w/w.

[0024] According to another embodiment of the present invention, a method for synthesis of dermal composition comprises of the following steps: i) transferring the water in a water heating tank followed by heating of the water at a temperature in the range of 70-75oC in order to obtain hot water, ii) adding the Brookswax D, almond oil, and Jojoba oil in a wax melting tank, followed by heating at a temperature in the range of 70-75oC and stirring for a time duration in the range of 3-8 minutes in order to obtain a solution, iii) mixing the hot water and solution in a mixing tank through vacuum at a negative pressure in the range of 250-350kg/cm2 under continuous stirring, followed by flushing nitrogen gas in the mixing tank at continuous stirring at a speed in the range of 20-30 RPM (Revolutions Per Minute) for a time duration in the range of 20-40 minutes using homogenizer, in order to obtain an emulsion, iv) adding the retinol, Aloe vera gel, zinc oxide, premix-A, premix-B, and premix-C in the mixing tank at a temperature in the range of 35-40oC followed by stirring at a speed in the range of 20-30 rpm, and homogenization at a speed in the range of 25-350 rpm for a time duration in the range of 10-20 minutes in order to obtain a mixture, and v) adding Phenoxyethanol and Ethylhexylglycerin in the mixture, followed by stirring at speed in the range of 20-25 rpm for a time duration in the range of 3-8 minutes in order to obtain the dermal composition.

[0025] The premix-A used herein comprises of 2.8 gm of glycerin, 6.24 gm aqua, 8gm of urea, nitrogen gas, and 0.1 gm of xanthum gum, the premix- B used herein comprises of 10 gm of lactic acid and 2.8 gm of sodium hydroxide, the premix-C used herein comprises of 0.5 gm of tea tree oil and 0.32 gm of camphor. The 0.650 gm of Phenoxyethanol and Ethylhexylglycerin used herein are added as preservatives and for fragrance.

EXAMPLE

[0026] The dermal composition comprises of: i) retinol in the range of 2-5% w/w, ii) Aloe vera gel in the range of 3-4% w/w, iii) zinc oxide in the range of 1-2 % w/w, iv) premix-A in the range of 15-20% w/w, v) premix-B in the range of 10-15% w/w, vi) premix-C in the range of 1-2% w/w, vii) Brookswax D in the range of 1-2% w/w, viii) almond oil in the range of 3-8% w/w, ix) Jojoba oil in the range of 1-2% w/w, x) 0.58% w/w of Phenoxyethanol and 0.065% of Ethylhexylglycerin , xi) water in the range of 53-58% w/w.

[0027] The dermal composition comprises of: 4 gm retinol, 3.5 gm Aloe vera gel, 0.5 gm zinc oxide, 15% w/w premix-A, 10% w/w premix-B, 1% w/w premix-C in the range of, 1.86gm Brookswax D, 5gm almond oil, 0.56gm Jojoba oil0.58% w/w of Phenoxyethanol and 0.065% of Ethylhexylglycerin and water in the range of 53-58% w/w.

[0028] The method for synthesis of dermal composition comprises of following steps: i) 55.86 gm of of purified water is transferred in a water heating tank followed by heating of the water at a temperature in the range of 70-75oC in order to obtain hot water, ii) 1.86 gm of Brookswax D, 5 gm of almond oil, and 0.56 gm of Jojoba oil is added in a wax melting tank, followed by heating at a temperature in the range of 70-75oC and stirring for a time duration in the range of 5 minutes in order to obtain a solution, iii) the hot water and solution is mixed in a mixing tank through vacuum at a negative pressure in the range of 300kg/cm2 under continuous stirring of 20 to 30 rpm, followed by flushing nitrogen gas in the mixing tank at continuous stirring at a speed in the range of 20-30 RPM (Revolutions Per Minute) for a time duration in the range of 30 minutes using homogenizer, in order to obtain an emulsion, iv) the 4 gm of retinol, 3.5 gm of Aloe vera gel, 0.5 gm of zinc oxide, premix-A, premix-B, and premix-C is added in the mixing tank at a temperature in the range of 35-40oC followed by stirring at a speed in the range of 25 rpm, and homogenization at a speed in the range of 3000 rpm for a time duration in the range of 15 minutes in order to obtain a mixture, and v) Phenoxyethanol and Ethylhexylglycerin is added in the mixture, followed by stirring at speed in the range of 20-25 rpm for a time duration in the range of 5 minutes in order to obtain the dermal composition.

[0029] Referring to Figure 1, a pictorial image of an each constituent along with its function is illustrated. The premix-A used herein comprises of glycerin, aqua, urea, nitrogen gas, and xanthum gum, the premix- B used herein comprises of lactic acid and sodium hydroxide, the premix-C used herein comprises of tea tree oil and camphor. The Phenoxyethanol and Ethylhexylglycerin used herein are added as preservatives and for fragrance.

[0030] The synthesized dermal composition was subjected to following type of evaluation: i) self-evaluation of subjects, ii) Dermatological evaluation: Cosmetic acceptability, iii) Dermatological Evaluation: Efficacy, and iv) Chromametry.

i) Self-evaluation of subjects:

[0031] 36 (18 males + 18 females) subjects were selected for the study. The subjects selected for this study were healthy males & females, aged between 19 and 47 years old, presenting Acanthosis Nigricans skin condition (i.e., Dark & velvety patches on skin around neck, knees and elbows).

[0032] The 36 (18 males and 18 females) subjects were selected for the study. The subject selected for this study were healthy males and females, aged between 19 to 47 years old, presenting Acanthosis Nigricans skin condition (i.e., Dark & velvety patches on skin around neck, knees and elbows).

[0033] The application was carried out by the subjects themselves at home; except the first application of test product was carried out at Mascot Spincontrol under the guidance of the CRA as showed in Table 1. The affected area was cleansed and pat dried. The required amount of the cream was applied on the area and massaged gently using fingertips. The product was applied twice a day in morning and night for the period of 7 days.

Table 1: Details of product application over an individual

Products Application area Frequency of application Application duration Conservation
Nigrifix Cream (NCF-30): Product A On the affected area
of the skin
Twice a day
7 days At an ambient temperature

[0034] The subjects were asked to answer self-evaluation questionnaire in order to evaluate dark, velvety patches and absorption of composition regarding the efficacy of the composition over an individual. Subject’s self-evaluation of each subject was done at T+7 days after the application of composition over neck, knees and elbow regions.

[0035] The subjects filled in the questionnaire individually without any extrinsic influences (other volunteers and results of technical measurements). The filling of the questionnaires was performed under control of the CRA who checked the acquisition according to standard procedure. The questionnaires were carried out in accordance with the promoter as follows related to the product efficacy, physical characterization and product safety: i) the composition helps in reducing the appearance of dark & velvety patches on Neck, ii) The composition helps in reducing the appearance of dark & velvety patches on Knees and iii) The composition helps in reducing the appearance of dark & velvety patches on Elbows, iv) the composition spreads properly, v) the composition gets quickly absorbed in skin, vi) the composition does not cause itching, vii) the composition does not cause irritation, viii) the composition does not give burning sensation.

[0036] Referring to Table 2, a tabular representation of questionnaires were carried out in accordance with the promoter as follows related to the product efficacy, physical characterization and product safety is illustrated.

Table 2: questionnaires were carried out in accordance with the promoter as follows related to the product efficacy, physical characterization and product safety

[0037] As show in Table 2, it was observed that Product A, all the suggested items are significantly and highly recognized by the panel, after T+7 days with 97% to100% of agreement for all the items. Concerning the product efficacy, test product A is well appreciated for reducing the appearance of dark & velvety patches on Neck and Elbows with 100% agreement and for reducing the appearance of dark & velvety patches on Knees with 97% agreement after T+7 days of product application.

[0038] Concerning the physical characteristics, test product A is well appreciated for spread ability and for quick absorption in skin with 100% agreement at given time point.

[0039] Concerning the product acceptability, test product A is well appreciated for not causing itching, irritation & burning sensation with 100 % agreement at given time point.

ii) Dermatological evaluation: Cosmetic acceptability:

[0040] The safety of the dermal composition was assessed by the dermatologist, through the grading on the affected area (Neck, Knees and Elbow) of defined clinical signs (observed by the dermatologist) and functional signs (felt by the subjects and reported to the dermatologist), at T0 and T+7 days visits, as follows: i) Erythema, ii) Itching, iii) Oedema, iv) Tingling, v) Dryness, vi) Scaling and vii) Peeling. The evaluation was carried out The evaluation was carried out under a controlled temperature and relative humidity (temperature: 20°C to 25°C, hygrometry: 50 ±10%). The lighting was ensured by a ceiling lamp.

[0041] Referring to Table 3, a tabular representation of an evaluation of cosmetic acceptability carried out under controlled temperature and relative humidity is illustrated.

Table 3: an evaluation of cosmetic acceptability carried out under controlled temperature and relative humidity

[0042] As shown in table 3, the dermatologist recorded the appearance of Erythema for 1 subject, Dryness for 11 subjects, Scaling for 8 subjects, Peeling for 9 subjects of grade 1 and Itching for 6 subjects of grade 1 & 1 subject of grade 2 for Neck at T+7 days. The dermatologist recorded the appearance of Scaling for 1 subject and peeling for 1 subject of grade 1 at T+7 days for Elbows.

iii) Dermatological Evaluation: Efficacy:

[0043] The product efficacy, was assessed by the dermatologist, through the grading at T0 and T+7 days visits of Neck, Elbow and knee: i) Area (A) Index: 0: No Involvement, 1: <10% , 2: 10-29% , 3: 30-49% , 4: 50-69%, 5: 70-100%, ii) Pigmentation (P): 0: Absent, 1: mild, 2: Moderate, 3: Marked, 4: Severe, and iii) Thickness (T): 0: Absent, 1: mild, 2: Moderate, 3: Marked, 4: Severe.

[0044] The total score of efficacies is calculated by means of following formula:

Total Score: P+T= x A =

[0045] Referring to Table 4, a raw value of total score of efficacies of dermal composition over an individual is illustrated. The means and standard deviations of the grades of the studied parameters observed on the treated areas (Neck, Elbow and Knees) with test Product A at T0 & T+7 days as well as the corresponding statistical results for the evolution in time (Student test or Wilcoxon test, two-tailed for paired groups at 5%, after checking the normality of the distributions by a Shapiro- Wilk test at 1%).

Table 4: Raw values of total score of efficacy of dermal composition over an individual

[0046] Referring to Table 5, an Evolution (Tn-T0) of total score of efficacy of dermal composition over an individual is illustrated. The means and the standard deviations of the evolutions (Tn-T0) of the grades of the studied parameters, observed on the treated areas with composition.

Table 5: Evolution (Tn-T0) of total score of efficacy of dermal composition over an individual

[0047] Referring to Table 6, a Variations (Tn-T0)/T0 (%) of total score of efficacy of dermal composition over an individual is illustrated. the average percentages of the variation (Tn-T0)/T0 of the grades of the studied parameters observed on the treated areas with composition, calculated from the average values.

Table 6: Variations (Tn-T0)/T0 (%) of total score of efficacy of dermal composition over an individual

[0048] Referring to Figure 2, a graphical representation of total score of efficacy of dermal composition over a treated area (Elbow, neck and knees) are illustrated. The statistical analysis shows a significant decrease in Total Score for Neck, Elbows and Knees by -29.3%, -29.6% and -31.4% respectively on treated areas with composition on average of whole panel after T+7 days of application. 86%, 92% & 83% of the panel presented an improvement in the studied parameter for Neck, Elbows and Knees respectively after T+7 days of application.

[0049] The texture of neck, elbows and knees observed by following type of evaluation: i) 0: Smooth to touch: no differentiation from normal skin to palpation, ii) 1: Rough to touch: clearly differentiated from normal skin, iii) 2: Coarseness can be observed visually, portions of the skin clearly raised above other areas, iv) 3: Extremely coarse: “hills and valleys” observable on visual examination.

[0050] Referring to Table 7, a raw values of texture of efficacy of dermal composition over an individual is illustrated. the means and standard deviations of the grades of the studied parameters observed on the treated areas (Neck, Elbow and Knees) with test Product A at T0 & T+7 days as well as the corresponding statistical results for the evolution in time (Student test or Wilcoxon test, two-tailed for paired groups at 5%, after checking the normality of the distributions by a Shapiro- Wilk test at 1%).

Table 7: Raw values of texture of efficacy of dermal composition over an individual

[0051] Referring to Table 8, an Evolution (Tn-T0) of texture of efficacy of dermal composition over an individual is illustrated. The means and the standard deviations of the evolutions (Tn-T0) of the grades of the studied parameters, observed on the treated areas with composition.

Table 8: Evolution (Tn-T0) of texture of efficacy of dermal composition over an individual

[0052] Referring to Table 9, a Variations (Tn-T0)/T0 (%) of texture of efficacy of dermal composition over an individual is illustrated. the average percentages of the variation (Tn-T0)/T0 of the grades of the studied parameters observed on the treated areas with composition, calculated from the average values.

Table 9: Variations (Tn-T0)/T0 (%) of texture of efficacy of dermal composition over an individual

[0053] Referring to Figure 3, a graphical representation of Texture of efficacy of dermal composition over a treated area (Elbow, neck and knees) are illustrated. The statistical analysis shows a significant decrease in the texture grade for Neck, Elbows and Knees by -26.9%, -24.6% and -15.2% respectively on treated areas with composition on average of whole panel after T+7 days of application. 83%, 91% & 85% of the panel presented an improvement in the studied parameter for Neck, Elbows and Knees respectively after T+7 days of application.

iv) Chromametry:

[0054] Tristimulus colorimeters are made of a control unit and a measurement headline associated. The measurement headline takes the measurements from a zone of 8mm in diameter and uses a diffuse lighting as well as an angle of 0° (including specular component). The headline measurement has a light with a pulsed xenon arch lamp. A double beam system measures the incident light and the reflected light by means of six photocells. The used material is a Chromameter CR-400 (Minolta).

[0055] The measurements were performed on neck, knees and elbows for skin brightening. The site of the instrumental measurements and their location at the different points of the kinetics was strictly the most reproducible. The location was determined by a cutaneous marking on the instrumental measurement sites at T0. In order to reposition this marking accurately while the measurements were taken, a mapping of the skin’s surface, for the measurement site and for each subject, was made on a transparent film.

[0056] Referring to Table 10, a tabular representation of a raw values of chromametry of dermal composition is illustrated. The means and standard deviations of the raw values of L* observed on the treated areas (Neck, Elbow and Knees) with test Product A at T0 & T+7 days as well as the corresponding statistical results for the evolution in time (Student t test, two-tailed for paired groups at 5%).

Table 10: raw values of chromametry of dermal composition

[0057] Referring to Table 11, an Evolution (Tn-T0) of chromametry of dermal composition over an individual is illustrated. The means and the standard deviations of the evolutions (Tn-T0) of L* observed on the treated areas (Neck, Elbow and Knees) treated with dermal composition.

Table 11: Evolution (Tn-T0) of chromametry of dermal composition over an individual

[0058] Referring to Table 12, a Variations (Tn-T0)/T0 (%) of chromametry of dermal composition over an individual is illustrated. The average percentages of the variation (Tn-T0)/T0 of L* observed on the treated areas (Neck, Elbow and Knees) with test dermal composition, calculated from the average values.

Table 12: Variations (Tn-T0)/T0 (%) of chromametry of dermal composition over an individual

[0059] Referring to Figure 4, a graphical representation of chromametry of dermal composition over a treated area (Elbow, neck and knees) are illustrated. The statistical analysis shows a significant increase in L* parameter by 6.2%, 5.3% & 4.9% for Neck, Elbow and Knees respectively when treated with dermal solution on average on whole panel after T+7 days of application. 92%, 94% & 92% of the panel presented an improvement in the studied parameter after T+7 days of test product application.

[0060] The twice a day application of the test product coded Nigrifix Cream (NCF-30): dermal composition, on a panel of 36 Indian male and female subjects aged between 19 and 47 years old, having Acanthosis Nigricans skin condition (i.e., Dark & velvety patches on skin around neck, knees and elbows), leads to the following results after T+7 days of product application.

[0061] Subject’s Self Evaluation: On the basis of subject self-evaluation all the claims related to product efficacy, physical characteristics & product safety, are significantly validated by the panel after 7 days of application of composition.

[0062] Dermatological Evaluation for Cosmetic Acceptability: On the basis of Dermatological Evaluation for cosmetic acceptability, on the whole panel, 15 subjects showed clinical and functional signs on neck, 1 subject clinical signs on elbows. However no clinical and functional signs observed on knees after 7 days of application of composition.

[0063] Dermatological Evaluation for Efficacy: On the basis of Dermatological Evaluation for efficacy, on the whole panel, a significant decrease in the Total Score for Neck, Elbows and Knees shows effect in terms of improvement in studied parameter when treated with composition on average on whole panel after 7 days of test product application. On the basis of Dermatological Evaluation for efficacy, on the whole panel, a significant decrease in the Texture grade for Neck, Elbows and Knees shows effect in terms of improvement in studied parameter when treated with composition on average on whole panel after 7 days of test product application.

[0064] Chromametry: A significant increase in L* parameter for Neck, Elbows and Knees by 6.2%, 5.3% & 4.9% respectively shows an effect of the product in terms of Skin Brightening after 7 days of application of composition.

[0065] Although the field of the invention has been described herein with limited reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the invention, will become apparent to persons skilled in the art upon reference to the description of the invention.

We Claims:

1) A dermal composition comprising: 2-5% w/w of retinol, 3-4%w/w of Aloe vera gel, 1-2 %w/w of zinc oxide, 15-20%w/w of premix-A, 10-15%w/w of premix-B, 1-2 %w/w of premix-C, 1-2 %w/w of Brookswax D, 3-8%w/w of almond oil, 1-2%w/w of Jojoba oil, 0.58% w/w of Phenoxyethanol and 0.065% of Ethylhexylglycerin and 53-58%w/w of water.

2) The dermal composition as claimed in claim 1, comprising: 4 gm retinol, 3.5 gm Aloe vera gel, 0.5 gm zinc oxide, 15%w/w of premix-A, 10%w/w of premix-B, 1%w/w of premix-C, 1.86gm Brookswax D, 5gm almond oil, 0.56gm Jojoba oil and 53-58%w/w of water.

3) The composition as claimed in claim 1, wherein said premix-A comprises of 2.8 gm of glycerin, 6.24 gm aqua, 8gm of urea, nitrogen gas, and 0.1 gm of xanthum gum.

4) The composition as claimed in claim 1, wherein said premix-B comprises of 10 gm of lactic acid and 2.8 gm of sodium hydroxide.

5) The composition as claimed in claim 1, wherein said premix-C comprises of 0.5 gm of tea tree oil and 0.32 gm of camphor.

6) A method for preparation of said composition, comprising the step:

a) transferring said water in a water heating tank followed by heating of said water at a temperature in the range of 70-75oC in order to obtain hot water;
b) adding said Brookswax D, almond oil, and Jojoba oil in a wax melting tank, followed by heating at a temperature in the range of 70-75oC and stirring for a time duration in the range of 3-8 minutes in order to obtain a solution;
c) mixing said hot water and solution in a mixing tank through vacuum at a negative pressure in the range of 250-350kg/cm2 under continuous stirring, followed by flushing nitrogen gas in said mixing tank at continuous stirring at a speed in the range of 20-30 RPM (Revolutions Per Minute) for a time duration in the range of 20-40 minutes using homogenizer, in order to obtain an emulsion;
d) adding said retinol, Aloe vera gel, zinc oxide, premix-A, premix-B, and premix-C in said mixing tank at a temperature in the range of 35-40oC followed by stirring at a speed in the range of 20-30 rpm, and homogenization at a speed in the range of 25-350 rpm for a time duration in the range of 10-20 minutes in order to obtain a mixture; and
e) adding 0.58% w/w of Phenoxyethanol and 0.065% of Ethylhexylglycerin in said mixture, followed by stirring at speed in the range of 20-25 rpm for a time duration in the range of 3-8 minutes in order to obtain said dermal composition.

7) The method as claimed in claim 6, wherein said Phenoxyethanol and Ethylhexylglycerin are added as preservatives and for fragrance.