Healing composition for topical application

Abstract

The present invention relates to a hygiene product or a pharmaceutical composition in the form of a gel or dressing, for topical application to the skin or mucosa including glycerol, at least one poly(meth)acrylate polymer, at least one polyethylene glycol having a molecular weight of less than 1000 g/mol, octanediol and water. The composition or dressing can be used for healing treatment of chronic dermal ulcers, healing and soothing treatment of eczema and psoriatic conditions, healing treatment of anal fissures, treatment of mouth injuries, resorption and healing of labial herpes (cold sore) and treatment of dermatitis. The hygiene product can be a shaving or aftershave product for sensitive or hypersensitive skin, a nasal decongestant product or a product for ear hygiene.

Claims

1. A hydrogel composition for topical application to acute or chronic wounds or lesions of skin or mucosa affecting the dermis, consisting of: water, 0.5-1.5% by weight of 1,2-octanediol, 5-25% by weight of glycerol, 1-5% by weight of polyethylene glycol having a molecular mass of the order of 400 g/mol, and 0.01-2% by weight of at least one poly(meth)acrylate polymer, wherein the percentages by weight are expressed relative to the total weight of the composition.

2. The composition as claimed in claim 1, wherein the lesions of skin or mucosa are oozing lesions, and produce liquids such as lymph, blood or pus.

3. The composition as claimed in claim 1, wherein the composition absorbs liquids such as lymph, blood or pus that are produced by the lesions.

4. The composition as claimed in claim 1, wherein said composition comprises at least two poly(meth)acrylate polymers.

5. The composition as claimed in claim 1, wherein 1,2-octanediol, glycerol, polyethylene glycol, and poly(meth)acrylate polymer are provided in a sufficient amount to induce at least one effect selected from the group consisting of avoiding infection, limiting loss of tissue by necrosis, limiting oozing, controlling edema, and relieving pain.

Description

EXAMPLES

Example 1: Healing Treatment of Acute or Chronic Wounds

(1) A single center prospective noncomparative clinical trial was carried out on volunteer patients suffering from various types of skin lesions. The average age was 60.3 years. The causes of the healing problems were mainly due to pressure ulcers (6 cases), foot cicatrices (7 cases), varicose ulcers (10 cases), deep second degree burns (2 cases), bullous dermatoses of the legs (3 cases), a fissure between the toes (2 cases) and a trauma ulcer (2 cases). The lower limbs were the main location (80%).

(2) The composition which was applied was a hydrogel composed of water, of 0.5-1.5% by weight of 1,2-octanediol, of 5-10% by weight of glycerol, of 1-5% by weight of polyethylene glycol having a molecular mass of the order of 400 g/mol, of methyl polymethacrylate, of crosslinked acrylate/C10-30 alkyl acrylate polymer and of sodium polyacrylate.

(3) The product was applied daily as a thick layer after having thoroughly cleaned the wound with physiological saline and having covered it with a sterile compress. The application of any other product to the studied area was avoided during the entire duration of the trial.

(4) Evaluation Protocol:

(5) The progression of the cicatrix was evaluated by iconography taken every week during the first 2 weeks, and then every month. It was evaluated by the patient and the doctor at the same time. The main final point was the level of re-epithelialization, the assessment of the efficacy and safety of the product (by the doctor) and the time for the disappearance of pain, oozing and erythema (by the doctor and the patient).

(6) Results:

(7) The results observed on a portion of the patients were not taken into account because of non compliance with the application.

(8) The period for the disappearance of the erythema, of the pain and of the oozing was 1 week in 80% of the cases. The beginning of the cure was noted in the second week in 50% of the subjects. The treatment was applied for 3 months in 50% of the cases. The application was extended for more than 4 months in 4 cases. There was no side effect noted and the tolerance was judged to be good to very good in 100% of the cases.

Example 2: Evaluation of the Healing Efficacy on Lesions Post-Dermatological Procedure

(9) A comparative randomized study with the ointment HYALUZINC was carried out. This study was performed on 2 groups of 22 volunteers having a lesion after a procedure with liquid nitrogen on keratoses or pigmented spots. The clinical signs are evaluated on D0, D12-D15 and D28 (in particular the reepithelialization of the lesion, the size of the lesion, the period for healing).

(10) The composition of the invention was provided as a hydrogel composed of water, of 0.5-1.5% by weight of 1,2-octanediol, of 5-10% by weight of glycerol, of 1-5% by weight of polyethylene glycol having a molecular mass of the order of 400 g/mol, of methyl polymethacrylate, of crosslinked acrylate/alkyl C10-30 acrylate polymer and of sodium polyacrylate.

(11) on D12-D15, the degree of reepithelialization of the lesion was 82% against 70% for the HYALUZINC (positive control).

(12) the softness of the skin was high or average in 90% of the subjects treated with the composition of the invention.

(13) absence of residual cicatrix and of residual achromic spot in 100% of the subjects treated with the composition of the invention.

(14) the period for complete healing of the lesion was 11 days for the composition of the invention and 13.2 days for the positive control.

(15) These results demonstrate a healing activity that is at least comparable, or even greater than that of a reference healing composition HYALUZINC.

Example 3: Healing Treatment of Anal Fissures

(16) For this study, a first line or second line treatment of anal fissures was carried out on 30 subjects with the composition of example 1 compared with a positive control (ointment HEC).

(17) The results obtained after 3 weeks of treatment clearly demonstrate for the product of the invention better healing, including in the second line recidivous fissures. The healing is complete in 80% of the cases.

(18) In all the cases, there is a marked decrease in the associated pain (greater than 80%).

Example 4: Healing Treatment of Mouth Injuries

(19) A study was carried out on 7 cases with the composition of example 1 on persons with aphthae.

(20) The healing power of the composition of the invention allows good resorption of the injuries by 80% and a rapid decrease in the associated pain by 90%.

Example 5: Healing of Labial Herpes Spots

(21) This example relates to a test carried out on 10 volunteers with labial herpes (cold sore) by local application of the composition of example 1.

(22) The results observed are a deflation of the blister, within a few hours after the first application, and following several applications a gradual stopping of the inflammation and a rapid subsequent healing (2 to 5 days depending on the size of the lesion).

Example 6: Nasal Decongestant

(23) Study carried out on 25 persons having symptoms of blocked nose in an equivalent manner on both sides.

(24) The composition of the invention is locally applied and spread over the left nasal cavity, the right nasal cavity serving as a control.

(25) The result is an immediate decongestant effect on the treated nostril compared with the untreated nostril (greater than 90%). This state lasts depending on the condition for at least 20 to 30 minutes. The operation is then repeated with the same result. Furthermore, a decrease in reddening and in pain (greater than 80%) is observed in parallel on the treated side.

Example 7: Healing of Wasp, Horsefly and Jellyfish Stings

(26) A study was carried out on 5 cases of jellyfish stings, 5 cases of horsefly stings and 10 cases of wasp stings.

(27) In the case of the horseflies and the wasps, in 100% of the cases, the pain disappeared between 1 to 3 minutes maximum. There was no inflammation or reddening and the sting mark disappeared within a few hours.

(28) As regards the stings of jellyfish of the Pelagianoctiluca type, a very urticant Mediterranean species, if the composition were applied less than 2 minutes after the sting, the pain disappeared between 5 and 10 minutes.

(29) The inflammation is minimal and the sting marks do not last for more than 48 hours in all the stinging cases.

Example 8: Healing Treatment of Seborrheic Dermatitis of the Face

(30) This study was carried out with 15 volunteers with seborrheic dermatitis of the face over 4 weeks.

(31) The composition of example 1 was applied in the form of a hydrogel. This gel statistically significantly reduced the inflammatory lesions (26%), it made it possible to cool and remoisturize the epidermis, allowed tightening of the distended pores (15%) and a decrease in the comedones (18%). A decrease was observed in the reddening associated with good healing of the lesions with the disappearance of the yellowish scales and scabs.

Example 9: Healing and Soothing Treatment of Eczema and Psoriatic Conditions

(32) A study was carried out on 10 cases with eczema and on 5 cases with psoriatic conditions by applying the composition of example 1 for a period of four weeks.

(33) The pain and oozing decreased by 90% after 4 to 6 applications. In both types of condition, it is possible to note the 80% decrease in reddening after ten days of treatment.

(34) Here again, the healing and soothing effect after local application of a composition according to the invention in order to combat an eczema or a psoriatic condition proved particularly effective.

Example 10: Healing Treatment of Diaper Rashes in Children and Adults

(35) A study on 23 cases clearly demonstrated the favorable results of the composition of the invention. Indeed, after 12 to 48 hours depending on the extent of the erythema, the latter disappeared by nearly 95%. It was always accompanied by good healing and a disappearance of the pain.