FIELD OF INVENTION

This invention relates to the treatment of skin conditions requiring stimulation of melanocyte proliferation. It is a special herbal application for the treatment of leucoderma or vitiligo. This invention includes a herbal composition, preparation and the method of application thereof.

BACKGROUND OF INVENTION

Vitiligo is commonly called white spots illness or Leucoderma. Vitiligo or lecucoderma is a disease that is characterized by depigmentation patches of skin that occurs on the extremities. The patches are initially small; they often enlarge and change shape. They are most prominent on the face, hands and wrists. It has many symptoms all over body from head to feet with white patches and white small dots. They start appearing on the skin and diverse parts of the body all of a sudden and victims are very worried to observe changing their condition with white spots. White patches on skin are more common in sun-exposed areas, including the hands, feet, arms, face, and lips. The hair that grows on Vitiligo affected areas turns white sometimes. It is a circumstance in which white patches develop on the skin. The whole body can be affected and most of the people having Vitiligo may have white patches on vast area in very initial stage. Depigmentation is particularly noticeable around body orifices, such as the mouth, eyes, nostrils, genitalia and umbilicus. Some lesions have hyper pigmentation around the edges. Patients who are stigmatised for their condition may experience depression and similar mood disorders.

Vitiligo/Leucoderma is a condition that causes depigmentation of patches of skin. It occurs when melanocytes, the cells responsible for skin pigmentation, die or are unable to function. The cause of vitiligo is unknown, but research suggests that it may arise from autoimmune, genetic, oxidative stress, neural, or viral causes. The incidence worldwide is less than 1%.

Generally Vitiligo appears in one of three patterns. The focal pattern is more common in which depigmentation is limited to one or a few areas of the body. However there is no way to foresee Vitiligo if it will increase. The disorder is on the whole progressive with time when these white spots extends to the other areas of the body. Vitiligo extends slowly may be over long years in some cases while in most of the cases it extends speedily. A few people have also stated that supplementary depigmentation is subsequent to the substantial period. People of all age levels may be carrier of Vitiligo and every body part might be affected in any time at any age. People still rely on herbal medicine for the treatment of vitiligo. It is the most popular and satisfactory treatment adopted through out the world.

Presently there are various methods of treating Vitiligo, but they have some disadvantages like side effects, prolonged duration of treatment, difficulty in application or highly priced. Current method of treatment includes the use of photosensitsers like psoralens with UVA radiation called PUVA, corticosteroids or skin grafting having low success rates which is accompanied by unpleasant side effects. Further they cause complications when used in combination with other medications and may not be advisable for use in children, pregnant women and those incompatible with drugs., Hence there has been a long felt necessity for a potent, cost effective medicine that does not produce side effects. The present invention the herbal anti lecucoderma cream overcomes the fore said defeciencies by being a complete herbal composition needing one time topical application everyday. It does not require any supplementary treatment like laser treatment or steroid application.

SUMMARY OF INVENTION

The herbal leucoderma cream is a product containing natural plant parts and essential oils that can be applied topically for treating leucoderma. All the ingredients used in the preparation of Anti Leucoderma cream are purely of herbal origin. It contains natural plant parts and essential oils such as tea tree oil, Orange oil, Lavender oil in a vanishing cream base. It particularly acts by improving pigmentation on white patches and immunity. Even though vitiligo patches are known to be devoid of melanocytes, a reservoir of melanocyte exist in hair follicles in vitiliginous skin which is activated by this herbal leucoderma cream. Herbal Anti Vitiligo cream penetrates through skin pores & starts repigmentation within 4-6 weeks over white patches . It also prevents the spreading of disease to the other parts of the body. It does not produce any toxic effect and the patients do not experience any kind of discomfort. The herbal lecucoderma cream is easy to apply and affordable.

DETAILED DESCRIPTION OF INVENTION

The herbal leucoderma cream is prepared from a combination of whole extracts of six varieties of plants namely Psoralea corylifolia, Embelia ribes, Plumbago zeylanica, Cassia fistula, Curcuma lunga and Azadirachta indica, which is the active ingredient. The active ingredient may be used on its own, but is suitable for application when combined with a carrier or excipient. The active derivative or analogue thereof can be administered by oral, topical, intravenous or subcutaneous routes but is preferably applied topically to the affected area. The active ingredient can be formulated as a solid powder, paste, ointment, cream, tablet, capsules, solution etc., The treatment can be used for therapeutic, prophylactic and cosmetic purposes.

The present herbal preparation describes the method of preparing the herbal leucoderma cream which makes use of topical application. The preparation is divided in to three parts the first part wherein the lipophilic phase is prepared, the second part involving the hydrophilic phase wherein the extracts of all the six plant parts are mixed and the third and final part of adding essential oils. The contents of all the three parts of the herbal leucoderma cream and their quantities are tabulated in Table 1. The preparation of herbal cream is initiated by first preparing the lipophilic phase. The lipophilic phase is obtained by thoroughly mixing the required quantities of light liquid paraffin, stearic acid, cetyl alcohol, isopropyl myristate, propyl paraben in a clean dry container. Secondly the hydrophilic phase containing the six plant parts constituting the active ingredient is prepared. The six plants used for this preparation are Psoralea corylifolia, Embelia ribes, Plumbago zeylanica, Cassia fistula, Curcuma lunga, Azadirachta indica and are extracted from various plant parts such as dry fruits seeds powder, dry fruit powder, roots powder, leaf powder, rhizomes powder, leaf powder respectively. The mixture of all these extracts forms the active ingredient which is in a hydrophilic phase. The hydrophilic phase is prepared by mixing the required quantities of active ingredients with sulphur powder and passing through the sieve number 100. Required quantities of glycerine, triethanolamine, methyl paraben and 50 to 60ml of water are added to this sieved mixture of herbs and sulphur powder constituting the hydrophilic phase. Quantities as mentioned in Table 1. The dosage may vary according to the age of the patient and severity of the disease.

The lipophilic phase and hydrophilic phase are heated to 70 to 80°C and blended together by continuous stirring to from a homogenous cream. This preparation is allowed to reach 40°C under room temperature. After reaching the desired temperature the essential oils as mentioned under part 3 of table 1 are added to the hydrolipophilic mixture. After reaching the room temperature the cream is filled into a neatly labelled container.

The cream thus formulated is evaluated for various parameters described as under to confirm its efficacy, Safety and suitability for use by the human subjects.

TABLE-1: COMPOSITION OF HERBAL CREAM FOR THE TREATMENT OF LEUCODERMA

CREAM EVALUATION

The formulated cream was studied for their stability for six months duration as per ICH guidelines. The pH of the preparation was found out by using surface pH meter. Viscosity of the preparation was found out by the rheometer (Brookfield rheometer plate and cone viscometer L.V.T. Ill with Rheocal software. Temperature stability of the creams at 4, 27, and 40 degrees were studied for 6months. The creams were also observed for any colour change during the stability study period. No colour change was observed. The pH of the creams remained between 6.0 to 7. Viscosity of the formulations was 220 Cps without any change. Formulations are stable at different temperatures for 1 year when conducted as per ICH guidelines and accelerated stability studies. No changes were observed in perfume characteristics for 1 year on storage.

The herbal formulation was tested for irritation and sensitivity invivo before subjecting to test on human volunteers. The tests conducted were Draize irritation test and Predictive Sensitivity testing. The details of the tests are given as under:

PRIMARY IRRITATION TEST

PROCEDURE

This test was conducted on male albino rabbits by Draize irritation test on both abraded and intact skin. 0.5gm of the cream formulation was applied using cotton swabs and the patches were held fast on the skin using non allergic adhesive tapes. The animals were observed for skin reaction after 24hr, 48hr and 72hrs.

RESULT

No erythema or oedema was observed indicating that the formulation is devoid of any skin irritation hence the formulation was found to be safe to use on human volunteers.

PREDICTIVE SENSITIVITY TESTING

The ascertainment of the irritant and sensitizing potential of formulation is prophetic or predictive sensitivity testing. Under this testing the ingredients of the formulation, which were prone to cause irritation and sensitivity, were tested. The formulation as a whole was evaluated for the same.

PROCEDURE

The formulation was applied to 1 cm2 area of cotton gauze. The gauze was backed with adhesive tape in order to hold the gauze in position. Then 8 human volunteers were asked to apply this patch to the inner surface of forearm. The purpose of selection of this site for application was to enable the volunteer to readily remove the patch if any irritation is encountered.

The volunteers have been given instructions such that they remove the patch
immediately if they feel itching or burning, keep the patch site dry, avoid
rubbing or scratching any test site. The patch was kept in position for 24hrs.

RESULT

After 24hrs, the patch was removed. The test was observed after 40min from
the time of removal. This time interval is necessary so that the skin may
recover from the effects of pressure of certain patch test substances.

APPLICATION OF CREAM

Anti Leucoderma cream is very simple to use and needs to be applied only once a day. Treatment with Anti Leucoderma cream is very rapid and obvious results can be noticed within six weeks of its use. Re-pigmentation with Anti Leucoderma cream is permanent, results are mostly visible after 2 to 3 months (May be after some weeks) of regular application. Our patient volunteers have shown excellent results, with a 85% rate of success. In almost all cases, facial Leucoderma is fully cured within three months of use. A slightly longer period is required for other body regions and treatment can last up to four months. These are absolutely completely natural and herbal remedies having no side effects. This formulation is a most promising Herbal Remedy for the treatment of Leucoderma.

CLINICAL TRIALS

The formulation showed good stability and satisfied all parameters for testing after which it was tested for its efficiency in human volunteers who were suffering from leucoderma. Concern from the university college of pharmaceutical sciences Ethical committee was taken to conduct the clinical study on human volunteers who were suffering from leucoderma. Clinical study was conducted in University Health centre under the guidance of a qualified physician.

METHODOLOGY OF TESTING

Patients (12 numbers) with different age groups and sex were selected to undertake the treatment. Informed consent was taken. Patient consent form (form 3) was filled to avoid any legal hassles. Case record (Form 1) as per the hospital requirement was filled. Patients were advised to apply the cream twice a day and called weekly for follow up for 12 weeks. Various parameters such as Erythema, Itching, Oedema, Depigmentation were studied. Observations were filled in the given record form (Form 4). Physician's evaluation of the treatment response was regularly updated on the basis of various grades mentioned in the form 2.

EVALUATION

A single physician recorded all the clinical observation using the standard assessment scale mentioned in form 4. In these patient overall changes in various symptoms associated with leucoderma were compared with his or her appearance in the beginning of the study on a four point scale. The grading parameters are :

1. None: Sign not visible to physician

2. Mild: slight minimal but evident sign

3. Moderate: sign-average easily seen

4. Severe; extensive. Markedly evident

The percentage improvement in pigmentation was recorded during each follow up. Recording by single physician was intended to achieve uniformity in grading throughout the study.

DISCUSSION AND RESULT

Among the twelve volunteers there were two drop outs. Remaining ten volunteers cooperated with the study. Among these 8 (80%) volunteers clinically healed and showed good to excellent response. 2 (20%) volunteers clinically improved showing slight to fair increase in repigmentation over white patches. 1 volunteer (10%) showed variable response (sometimes good and sometimes poor) result. Summary of treatment effect (expressed as % cured)

Table:2 Figures excluding 2 dropouts

1. None: Sign not visible to physician

2. Mild; Slight minimal but evident sign

3. Moderate: Sign average easily seen

4. Severe; Extensive markedly evident

We Claim,

1. A herbal formulation efficient in stimulating melanocytes that can be
used for skin conditions requiring melanocyte proliferation
particularly Leucoderma or Vitiligo and consisting of

a. Preparation of Active ingredient

b. Preparation of herbal leucoderma cream

c. Application

2. The herbal formulation as claimed in claim la, wherein mixture of extracts obtained from six different plants viz., Psoralea corylifolia, Embelia ribes, Plumbago zeylanica, Cassia fistula, Curcuma lunga and Azadirachta indica constituting the active ingredients are used.

3. The herbal formulation as claimed in claims la, wherein the active derivative can be administered by oral, topical, intravenous or subcutaneous routes.

4. The herbal formulation as claimed in the above mentioned claims where in the active ingredient can be used as such or in combination with carrier or an excipient.

5. The herbal formulation as claimed in claim la wherein, the active ingredient can be formulated as a solid powder, paste, ointment, cream, tablet, capsules, solution etc.,

6. The herbal formulation as claimed in claims la & lb, wherein it can be used for therapeutic, prophylactic and cosmetic purposes.

7. The herbal formulation as claimed in claim 1, wherein the active ingredient is prepared in a cream base suitable for topical application.

8. The herbal formulation as claimed in claims 1&7, wherein the herbal leucoderma cream is prepared using three different phases viz., lipophilic phase, Hydrophilic phase, and essential oils.

9. The herbal formulation as claimed in claims 1 & 8, wherein the lipophilic phase is obtained by thoroughly mixing the required quantities of light liquid paraffin, stearic acid, cetyl alcohol, isopropyl myristate, propyl paraben in a clean dry container.

10. The herbal formulation as claimed in claims 1 & 8, wherein the
hydrophilic phase containing the active ingredients are prepared by
mixing the various extracts of the six different plants viz., Psoralea
corylifolia (dry fruits seeds powder), Embelia ribes (dry fruit powder),
Plumbago zeylanica (roots powder), Cassia fistula (leaf powder),
Curcuma lunga (rhizomes powder), Azadirachta indica (leaf powder)
as shown in table 1.

11. The herbal formulation as claimed in claims 1, 8 &10, wherein the hydrophilic phase is prepared by mixing the required quantities of active ingredients with sulphur powder and passing through the sieve number 100.

12. The herbal formulation as claimed in claim 11, wherein required quantities of glycerine, triethanolamine, methyl paraben and 50 to 60ml of water are added to this sieved mixture of herbs and sulphur powder constituting the hydrophilic phase.

13. The herbal formulation as claimed in claim 1, 9 &11, wherein the lipophilic phase and hydrophilic phase are heated to 70 to 80°C and blended together by continuous stirring to from a homogenous cream.

14. The herbal formulation as claimed in claims 1 & 13, wherein this preparation is allowed to reach 40°C under room temperature after which the essential oils as mentioned in Table 1 are added to the hydrolipophilic mixture and blended well.

15. The herbal formulation as claimed in claims 1 &14, wherein the final pH of the cream is between 6.0 to 7.0 and Viscosity at 220cps.

16. The herbal formulation as claimed in claims 1 & 15, wherein the cream after reaching room temperature is filled into neatly labelled containers.

17. The herbal formulation as claimed in the above mentioned claims, where in a single topical application at the affected part for a minimum of 2 to 3 months is required to show desirable effects.

18. The herbal formulation as claimed in the above mentioned claims, wherein the dosage may vary according to the age and severity of the disease.