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safety of glycolic acid in xanthelasma removal

Introduction

High demand for an easy and effective Xanthelasma removal solution brought us to develp a product for Xanthelasma removal brought us to develop of a gel to remove Xanthelasma and other benign lesions for cosmetic reasons only. The gel is meant to remove Xanthelasma and benign lesions for cosmetic reasons only by progessively peeling them off.

Safety and compliance

Labeling and manufacturing

Given the possibility of the gel to be neutralised by using water (see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875240/) the gel, is made safe by testing the product on a small area of the skin (as requested by the insurer). The labling has cautions stating “avoid contact with the eyes, do not eat, keep out of reach of children, read the instruction before use, patch test before use, test on a small area before full application. Not for daily use.” The product has been registered on the European portal for cosmetics and complies with all legislations on labling.The product is produced by La Farmacia Parati in Italy (holding the relevant ISO required by the legislator). The producut is sold to us by the partner company LEM SRL who sources the products from al Farmacia Parati SRL. The responsible person of manufacturing is Dott Mauro Castiglioni ( Phone +39 0362.561930 info@farmaciaparati.it). See documentation ISO certification enclosed. Should Areton Limited change manufacturer the new supplier will be compliant to GMP.

Instructions

The instructions are structured so that the warnings are presented first, tems and conditions of business second and instructions for use last. The instructions are very conservative and go well beyond all the foreseeable safety concerns in order to make the user wary and cautious once the product is received for use. The warning are over stated and sometimes exaggerated purposely, in order to make the user very coutious in the use of the product.

The same applies to the use of petroleum jelly to be used whilst applying the product. Petroleum jelly is not required with the use of the XanthRemover. Our testing testing as well as documented results prove beyond doubt that the use of petroleum jelly is not required. However this is added on to the instructions for use in order to increase further the level of safety byt raising consumer awareness.

In the instructions for use it is stated to conduct a series of patch tests before full application. Should the user be prone to allergic reactions, swelling or any adverse effects (effects which they are not happy with) they will become apparent the following day without causing any damage. In order to increase the level of safety even further, according to the instructions, the patch tests have to be carried out a number of times. (One is more than sufficient for insurance purposes). These further patch tests not only increase the level of safety but also make the users accustomed with the effects of the gel, so that they are better prepared, experienced and trained on the use of the product before full application to remove their own Xantelasma. Although not common, any swelling may last between 3 to 4 days at most they will subside by itself.

The priniciple of operation of the XanthRemover is that the degree of peeling effect is proportional to the length of application on the Xanthelasma. The longer the application the deeper the peeling effects of the Xanthelasma and therefore the less the applications required. Conversely the shorter the application the more the applicatons required for complete removal of the Xanthelasma.

For example:

Warning on: Potential permanent loss of vision, scarring, swelling, etc are exaggerated and overstated in order to make the user on their guard and avoid misuse of the product. Our research and experience has shown that irritation can occur but permanent or temporary loss of vision has never been reported due to accidental contact of the product with the eyes of this product (or glycolic acid in general). The same applies to the potential of permanent scarring, no case of scarring has been reported to date.

It has to be noted that scarring is a risk accepted by those who undergo Xanthelasma removal anyway. (In cosmetic clinics) consent forms for xanthelasma removal state that the risks of scarring cannot be excluded and our customers are warned in the same way before we dispatch the product out to them.

Safety Report

XanthRemover

Ingredients: Aqua, Glycolic acid 70% -75%, Excipients.

Glycolic acid is an alpha hydroxy acid (AHA) extracted from sugar cane and/or beetroot (natural substances). To ensure greater stability it is produced in a laboratory. The chemical form two atoms OHCOOH, containing only two atoms of carbon. It is thesmallest molecule of all other AHAs. Glycolic acid is used in various concentrations. It is a substance which is not subject to any limitation imposed in CosIng (European portal for cosmetics). The XanthRemover is a product suitable to remove xanthelasmas by exfoliation.

Indications: Removing xanthelasma and beningn lesions

Contraindications: Herpes, Application on broken skin, Pregnancy, Breastfeeding, Erythroderma, Couperosae, Sensitive Skin.


Test for sensitive skin:

Apply the product on the back of the forearm. Keep for 3 minutes and rinse. If the treated part presents redness and itching for longer than 24 hours, avoid the use of the product.

Possible side effects: swelling, erythema, itching, irritation, infection (due to external factors during the peeling process). Possible discolourations.

Warnings :Topical use only on intact skin. Avoid contact with mouth and eyes. If in contact with the eyes remove promptly by rinsing with warm running water, and if it is the case consult a specialist. The treated area should not be exposed to sunlight or UV lamps and must be protected with sunscreenwith total physical filter SPF50 +

  • Cleanse the part to be treated with mild cleansing milk or soap and rinse.
  • Dry thorougly by patting
  • Apply the product with cotton buds or with fingertips (rigorously cleaned), avoid contact with the eyes, mouth or nostrils (in which case remove promptly).
  • After application the user can experience an unpleasant burning sensation wich tends to fade. During the first application, keep the product to no more ‘than 5 minutes. However remove at the appearance of redness of the skin.
  • Rinse with warm water
  • Dry thorougly
  • Apply a gel with Aloe or a zinc oxide paste. (The use of soothing cream is optional but recommended)
  • Before exposure to sunlight always apply a sunscreen with SPF50+ to physical filters for seven days following treatment.
  • Increase ‘the time of application of the product until the appearance of a mild redening of the skin (which may vary from person to person)
  • From the third day from ‘application you will notice’ a slight flaking of the treated area.

Such treatment with the same procedure should be performed once a week for four consecutive weeks, then every two weeks and then once a month until the complete disappearance of the xanthelasmas.
Swelling can be treated by applying cold water or ice. Important irritation with zinc oxide paste. If the swelling lasts more than three weeks consult a doctor.
If the instructions as followed as prescribed, the product is to be considered safe.

The XanthRemover 1 is a 75% Glycolic acid peel for home use

The XanthRemover 2 is a 85% Glycolic acid peel for professional use

The XanthRemover 3 is a 90% Glycolic acid peel for professional use

All three formulationsa re registered in the EU portal for cosmetics were also copy of the labels are stored for inspection.

1. Herpes simplex (cold sores). You should receive preventive treatment prior to the peel.

blistering after the use of other peels (blistering is a very rare undesired side effect of glycolic acida and other AHA)

The glycolic acid gel should not be applied to those xanthelasma which is adjacent to the eyelashes as it would pose too much danger of contact of the glycolic acid with the eyes. In other words, should the xanthelasma e located too close to the eye so that the risk of part of the glycolic gel becoming in contact with the eye the user must refrain from applying the gel on this particular Xanthelasma? The judgment of whether the Xanthelasma is too close to the eye is left to the user as the user has control over the application of the gel.

  • Hypertrophic or keloidal scarring.
  • Warts in proposed treatment area.
  • Healing wounds in proposed treatment area.
  • Sunburn or wind burn in the 2 week period prior to proposed treatment.
  • Artificial tanning/sun bathing in the 6 week period prior to proposed treatment.
  • Waxing in proposed treatment area in the 2 week period prior to proposed treatment.
  • Accutane or other oral retinoid therapy in 6 month period prior to proposed treatment.
  • Current topical retinoid use (Differin, Retin-A, Tazorac). These products may be used to prepare/prep the skin for a peel.

Legislation defining a responsible person:
Legislation
Read More

Classification of the product.

Early concerns of the classification of the product as a medicine or medical device were clarified with the MHRA . The response of the MHRA was that the product due to its ingredients and intended use was neither classifiable as a medicine nor medical device . The more likely classification of the product is with a cosmetic peel as there are many cosmetic peels utilising the same ingredients on the marketplace. Additionally advise was sought with Ian Ferry of Renfrewshire Council, Tom Newton of Nottingham City council as well as extensive enquiries have been made with the MHRA. Copies of enquiries are kept on record.

Ingredients

The main active ingredients in the product is Glycolic acid the others are excipients (all ingredients are allowed in CosIng portal without restriction). Glycolic acid has been preferred to Triclorocetic acid (TCA) for two reasons:

  • It was found that glycolic acid-based peels are milder than TCA/li>
  • Easier to control than TCA. The longer the gel is kept on the more effective it becomes in removing the Xanthelasma and other benign skin lesions. TCA is very difficult to control. The only means of controlling TCA is by the use of a neutralizer. With the use of Glycolic acid, the effects can be stopped by wiping the gel and rinsing with water.
  • Very rare adverse effects (ie Swelling), which are very frequent with the use of TCA.

Effectiveness of Peels for Xanthelasma Removal.

It has been proven by numerous studies that Xanthelasma can be removed using a high concentration of TCA (trichloroacetic Acid) The concentrations of TCA in the studies vary between 50% and 100%. Ncbi.nlm.nih.gov

The above study confirms the results of the use of TCA at high concentration for the elimination of Xanthelasma. The conclusions State:
“100% TCA gives the best results in papulo-nodular lesions, 100% or 70% TCA give similar results in flat plaque xanthelasma and in macular lesions 50% is sufficient. Hypopigmentation is the commonest side effect, followed by hyperpigmentation. Scarring is a minor problem.”

The above study is not isolated, in fact, this other study confirms the findings of the one mentioned previously, however, the concentration used was 70% TCA http://www.ncbi.nlm.nih.gov/pubmed/19617785

The conclusions state:

“The results of prospective treatment of 24 patients with EX with 70% TCA indicated that this is a simple and effective method, achieves a satisfactory cosmetic result, has an acceptable recurrence rate, and high patient satisfaction.”

In the following study
The conclusions state:
“XP has a strong history of recurrence. TCA treatment may be effective in XP and is a short, simple and cheap procedure that can be repeated. Although the requirement for retreatment is high, patient satisfaction with the procedure is also high.”

The following further study compares laser erbium with TCA in the removal of Xanthelasma

NCBI“Conclusions: Both 70% TCA application and erbium: YAG laser ablation methods have similar effectiveness and complication rates.”

Read More

In the following study
The conclusions state:
“XP has a strong history of recurrence. TCA treatment may be effective in XP and is a short, simple and cheap procedure that can be repeated. Although the requirement for retreatment is high, patient satisfaction with the procedure is also high.”

The following further study compares laser erbium with TCA in the removal of Xanthelasma

NCBI“Conclusions: Both 70% TCA application and erbium: YAG laser ablation methods have similar effectiveness and complication rates.”

Read More

Why Glycolic Acid

TCA it is not very stable in a gel, and this tends to become watery too soon.

TCA causes temporary swelling and it may be required to be neutralized by using an appropriate product while the frosting is starting. (Frosting is that phenomenon which occurs soon after high concentrations of TCA, 50% or above are applied to the lesion or skin in general, the frosting does not happen with the use of Glycolic Acid or similar peels)

Therefore a substitute for the home use of a Xanthelasma Removal solution was found to be a cosmetic peel (glycolic Acid) which can be neutralized with water. The possibility of the neutralization of Glycolic acid experimented. It was found that the effects of glycolic acid are related to the duration of the application. The duration of the application is stopped by wiping the gel off and rinsing with water. However, the possibility of neutralizing Glycolic acid by using water is also corroborated in the following study:

“Alpha-hydroxy acid peels can be neutralized with water…..”
This applies to Glycolic acid and it was also demonstrated by our experience and tests.
The glycolic acid concentrations are required to have similar ablation effects to TCA, Glycolic acid concentration must be somewhat higher than the corresponding concentration of TCA Peel. This is corroborated not only by our experience but also by the following study on melasma using TCA T 15% and Glycolic acid at 70%

Due to the fact that Glycolic acid is easier to control and use it appeared to be a better substitute for home use than TCA because of the nearly absence of swelling which could have been due to a mild allergic reaction to GA and the ability of the user to control the superficial ablation o the Xanthelasma by neutralizing it with water when necessary. GA would generally not allow complete for removal of most Xanthelasma in one session as it is generally milder in its effects than TCA.

Why choosing concentrations around 75%?

It has to be made clear that the use of Glycolic acid is for the Xanthelasma and benign skin lesion removal and not skin rejuvination. Skin rejuvination is achieved by using glycolic acid based formulations at lower concentration. Low concentrations of glycolic acid do not achieve the level of satisfaction required by the user as they do become discouraged by the too mild peeling effects an they stop believing the xanthelasma solution will work for them. It was found that concentration of Glycolic acid in the region of 75% achieve a high level of satisfaction of the users as they are able to see apreaciable results after each aplication. (typically the peeling effect starts 2 to 3 days after the application)

Safety and compliance

Labeling and manufacturing

Given the possibility of the gel to be neutralised by using water (see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875240/) the gel, is made safe by testing the product on a small area of the skin (as requested by the insurer). The labling has cautions stating “avoid contact with the eyes, do not eat, keep out of reach of children, read the instruction before use, patch test before use, test on a small area before full application. Not for daily use.” The product has been registered on the European portal for cosmetics and complies with all legislations on labling.The product is produced by La Farmacia Parati in Italy (holding the relevant ISO required by the legislator). The producut is sold to us by the partner company LEM SRL who sources the products from al Farmacia Parati SRL. The responsible person of manufacturing is Dott Mauro Castiglioni ( Phone +39 0362.561930 info@farmaciaparati.it). See documentation ISO certification enclosed. Should Areton Limited change manufacturer the new supplier will be compliant to GMP.

Instructions

The instructions are structured so that the warnings are presented first, tems and conditions of business second and instructions for use last. The instructions are very conservative and go well beyond all the foreseeable safety concerns in order to make the user wary and cautious once the product is received for use. The warning are over stated and sometimes exaggerated purposely, in order to make the user very coutious in the use of the product.

The same applies to the use of petroleum jelly to be used whilst applying the product. Petroleum jelly is not required with the use of the XanthRemover. Our testing testing as well as documented results prove beyond doubt that the use of petroleum jelly is not required. However this is added on to the instructions for use in order to increase further the level of safety byt raising consumer awareness.

In the instructions for use it is stated to conduct a series of patch tests before full application. Should the user be prone to allergic reactions, swelling or any adverse effects (effects which they are not happy with) they will become apparent the following day without causing any damage. In order to increase the level of safety even further, according to the instructions, the patch tests have to be carried out a number of times. (One is more than sufficient for insurance purposes). These further patch tests not only increase the level of safety but also make the users accustomed with the effects of the gel, so that they are better prepared, experienced and trained on the use of the product before full application to remove their own Xantelasma. Although not common, any swelling may last between 3 to 4 days at most they will subside by itself.

The priniciple of operation of the XanthRemover is that the degree of peeling effect is proportional to the length of application on the Xanthelasma. The longer the application the deeper the peeling effects of the Xanthelasma and therefore the less the applications required. Conversely the shorter the application the more the applicatons required for complete removal of the Xanthelasma.

For example:

Warning on: Potential permanent loss of vision, scarring, swelling, etc are exaggerated and overstated in order to make the user on their guard and avoid misuse of the product. Our research and experience has shown that irritation can occur but permanent or temporary loss of vision has never been reported due to accidental contact of the product with the eyes of this product (or glycolic acid in general). The same applies to the potential of permanent scarring, no case of scarring has been reported to date.

It has to be noted that scarring is a risk accepted by those who undergo Xanthelasma removal anyway. (In cosmetic clinics) consent forms for xanthelasma removal state that the risks of scarring cannot be excluded and our customers are warned in the same way before we dispatch the product out to them.