COMPOSITION AND METHOD FOR TREATING PSORIASIS

Abstract

A composition and method for treating psoriasis comprising a mixture of tetrahydrocurcumin, tetrahydrodemethoxycurcumin and tetrahydrobisdemethoxy-curcumin formulated with pharmaceutically acceptable carriers and applied to the affected skin.

Description

DETAILED DESCRIPTION

Example 1

Clinical Study Validating the Efficacy of a THC Composition in Treating Psoriasis

• Study Duration: 45 days
• Population: 10 psoriasis affected subjects
• Intervention: THC formulated as a cream with pharmaceutically acceptable carriers applied topically three times a day for 45 days.

The primary objective in this study was to determine the efficacy and safety of the THC cream. The parameters to detect the efficacy and safety of the medication included relief from the characteristic symptoms of psoriasis like itching, erythema, scaling, infiltration, and the extent of clearance of psoriasis lesions.

Clinical improvement in the severity of psoriatic lesions as well as symptoms such as itching, erythema and scaling was observed in all subjects. Patients reported a gradual decrease in itching right from the first day of treatment.

A significant reduction in silvery scaling was observed from the 2nd week in all the subjects with visible clearance in the psoriatic lesions. A considerable reduction in erythema was found in all the subjects from week 2.

CONCLUSION: The cream formulation of THC offers relief from psoriatic lesions as evident by PASI (Psoriasis Area Severity Index) scores taken at the baseline, visit 1(3 weeks), and after 6 weeks as shown in Table 1.

TABLE 1
Comparative PASI score
	Subject No.	Baseline	Week 3	Week 6
	1	6.0	2.4	0.8*
	2	4.4	3.2	1.6*
	3	6.2	1.9	0.7*
	4	6.4	1.2	0.4*
	*Significant reduction in PASI score

TNF-α and VEGF concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), R and D Systems, USA. Plasma samples were analyzed for TNF-α and VEGF levels as per the protocol described by the manufacturer. The detection ranges of Human TNF-α and Human VEGF ELISA kit were 0.5 to 32 μg/ml and 31.2 to 2000 μg/ml respectively.

Significant reduction in TNF-α and VEGF concentrations was observed as shown in Table 2.

TABLE 2
TNF-α and VEGF Concentrations
	Plasma TNF-α		Plasma VEGF
SUBJECT	Baseline	Final	Baseline	Final
CODE	Mean (pg/ml)		Mean (pg/ml)
1	16.84	1.19*	192.74	116.38*
2	3.59	0.25*	62.59	38.00*
3	16.52	1.21*	87.31	53.13*
4	14.95	0.26*	253.45	50.13*
*Significant reduction in TNF-α and VEGF Concentration levels

The clinical outcome of this study clearly suggests the potential therapeutic use of the composition of the invention in treating psoriasis.

THC is a naturally derived composition for the treatment of psoriasis that offers comprehensive relief, and is devoid of toxic side effects unlike existing therapies.

Claims

1. A composition for the treatment of psoriasis comprising 0.01% to 5% w/w of tetrahydrocurcuminoids dispersed in a pharmaceutically acceptable carrier.

2. A composition according to claim 1 wherein the tetrahydrocurcuminoids comprise at least 95% w/w tetrahydrocurcumin.

3. A composition according to claim 1 wherein the tetrahydrocurcuminoids comprise 70-80% w/w tetrahydrocurcumin, 15-20% w/w tetrahydrodemethoxycurcumin, and 2.5-6.5% tetrahydrobisdemethoxycurcumin.

4. A method of treating psoriasis comprising applying a therapeutically effective amount of the composition described in claim 1 to the affected skin of the individual in need of treatment three times a day for a period ranging from 14 days to 90 days.

5. A method of reducing itching symptoms in psoriasis affected skin by applying to the affected area of the skin an effective amount of the composition of claim 1 three times a day for a period ranging from 1 day to 90 days.

6. A method of reducing scaling in psoriasis affected skin by applying to the affected area of the skin an effective amount of the composition of claim 1 three times a day for a period ranging from 1 day to 90 days.

7. A method of reducing serum levels of Vascular Endothelial Growth Factor (VEGF) in a psoriasis affected individual by using an effective amount of the composition of claim 1.