Hydrogel composition for the treatment of dermatological disorders

Abstract

The present patent application is related to a hydrogel composition which is essentially free of active drugs for the manufacture of a product for the treatment of dermatological disorders, especially perioral dermatitis, acne or seborrheic dermatitis.

Claims

1. A composition in form of a hydrogel which contains less than 0.01% of active pharmaceuticals, wherein the hydrogel contains (i) 5-15% propylene glycol (ii) 0-2% polyacrylic acid (iii) 0.5-3% lecithin (iv) 0.5-3% medium chain triglycerides or macrogol-glycerol hydroxystearate.

2. The composition in form of a hydrogel which contains less than 0.01% of active pharmaceuticals according to claim 1, wherein the hydrogel consists of one of the following compositions: TABLE-US-00002 1 2 3 4 5 6 7 8 9 Benzoic acid 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium edetate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium hydroxide 0.2 0.1 0.2 2 — 0.1 0.1 0.2 0.2 Polyacrylic acid 1.0 — 1.0 1.0 — 0.5 — 1.0 — Acrylic acid — 0.5 — — — — 0.3 — — copolymer Hydroxyethylcellulose — — — — — — — — 0.5 Xanthan gum — — — — 0.8 0.5 0.3 — — Propylene glycol 12.0 8.0 12.0 6.0 12.0 12.0 12.0 8.0 8.0 Glycerol — — — 6.0 — — — 8.0 — Polysorbate 80 1.5 1.5 1.5 — 1.5 1.5 1.5 1.5 1.5 Macrogol-glycerol- — — — 1.5 — — — — — hydroxystearate Medium chain 1.0 2.0 1.0 1.0 1.0 3.0 3.0 1.0 1.0 triglycerides Dimeticone — — 1.0 — — — — — — Liquid paraffin — — — — 1.0 — — — — Lecithin 1.0 2.0 1.0 1.0 1.0 1.5 1.0 1.0 1.0 Purified water to 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0.

3. A method for the treatment of perioral dermatitis, acne or seborrheic dermatitis, comprising administering a hydrogel which contains less than 0.01% of active pharmaceuticals, wherein the hydrogel contains (i) 5-15% propylene glycol (ii) 0-2% polyacrylic acid (iii) 0.5-3% lecithin (iv) 0.5-3% medium chain triglycerides or macrogol-glycerol hydroxystearate.

4. The method for the treatment of perioral dermatitis, acne or seborrheic dermatitis according to claim 3, wherein the hydrogel consists of one of the following compositions: TABLE-US-00003 1 2 3 4 5 6 7 8 9 Benzoic acid 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium edetate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium hydroxide 0.2 0.1 0.2 2 — 0.1 0.1 0.2 0.2 Polyacrylic acid 1.0 — 1.0 1.0 — 0.5 — 1.0 — Acrylic acid — 0.5 — — — — 0.3 — — copolymer Hydroxyethylcellulose — — — — — — — — 0.5 Xanthan gum — — — — 0.8 0.5 0.3 — — Propylene glycol 12.0 8.0 12.0 6.0 12.0 12.0 12.0 8.0 8.0 Glycerol — — — 6.0 — — — 8.0 — Polysorbate 80 1.5 1.5 1.5 — 1.5 1.5 1.5 1.5 1.5 Macrogol-glycerol- — — — 1.5 — — — — — hydroxystearate Medium chain 1.0 2.0 1.0 1.0 1.0 3.0 3.0 1.0 1.0 triglycerides Dimeticone — — 1.0 — — — — — — Liquid paraffin — — — — 1.0 — — — — Lecithin 1.0 2.0 1.0 1.0 1.0 1.5 1.0 1.0 1.0 Purified water to 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0.

5. A method of treatment of perioral dermatitis, acne or seborrheic dermatitis in a human, comprising topical administration of a hydrogel composition according to claim 1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows the reduction of mean perioral dermatitis (POD) score after treatment with hydrogel over 6 weeks time.

(2) FIG. 2 shows the reduction of mean lesion count after treatment with hydrogel over 6 weeks time.

(3) FIG. 3 shows the reduction of mean IGA score after treatment with hydrogel over 6 weeks time.

EXAMPLES

(4) 1.) Examples for hydrogels to be used in the indication perioral dermatitis or in the indication, seborrhoic dermatitis':

(5) TABLE-US-00001 1 2 3 4 5 6 7 8 9 Benzoic acid 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium edentate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Sodium hydroxide 0.2 0.1 0.2 2   — 0.1 0.1 0.2 0.2 Polyacrylic acid 1.0 — 1.0 1.0 — 0.5 — 1.0 — Acrylic acid copolymer — 0.5 — — — — 0.3 — — Hydroxyethylcellulose — — — — — — — — 0.5 Xanthan gum — — — — 0.8 0.5 0.3 — — Propylene glycol 12.0  8.0 12.0  6.0 12.0  12.0  12.0  8.0 8.0 Glycerol — — — 6.0 — — — 8.0 — Polysorbate 80 1.5 1.5 1.5 — 1.5 1.5 1.5 1.5 1.5 Macrogol-glycerol- — — 1.5 — — — — — hydroxystearate Medium chain 1.0 2.0 1.0 1.0 1.0 3.0 3.0 1.0 1.0 triglycerides Dimeticone — — 1.0 — — — — — — Liquid paraffin — — — — 1.0 — — — — Lecithin 1.0 2.0 1.0 1.0 1.0 1.5 1.0 1.0 1.0 Purified water to 100.0  100.0  100.0  100.0  100.0  100.0  100.0  100.0  100.0  Data provided in weight percent (wt. %).
2) In a recent observational study, 16 patients suffering from perioral dermatitis were treated with an active-free (=free of any active pharmaceutical ingredient) hydrogel formulation. Surprisingly, we observed a significant improvement of overall lesion count, perioral dermatitis (POD) score and investigators global assessment (IGA) score (FIG. 1-3).
3.) Patients suffering from Acne vulgaris are treated twice daily with one of the compositions according to Example 1. Surprisingly after 6 weeks the majority of the patients show a clinically remarkably improvement of their skin disorder.
4.) Patients suffering from seborrheic dermatitis are treated twice daily with one of the compositions according to Example 1. Surprisingly after 6 weeks the majority of the patients show a clinically remarkably improvement of their dermatological disease.

(6) Without further elaboration, it is believed that one skilled in the art can, using the preceding description, utilize the present invention to its fullest extent. The preceding preferred specific embodiments are, therefore, to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.

(7) The entire disclosures of all applications, patents and publications, cited herein and of corresponding European application No. 08075966.5, filed Dec. 23, 2008, are incorporated by reference herein.

(8) From the foregoing description, one skilled in the art can easily ascertain the essential characteristics of this invention and, without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions.