2 Oct 2020, 4:57am
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You Need to Stop Believing Myths About Eyelash Growth

“The eyes are the windows to the soul,” they say. Women spend a lot of time making sure that their eyes look perfect. Long and full lashes are a huge part of it. Most people are looking for ways to make eyelashes grow longer and thicker as we see all the celebrities on social media.

But the truth of the matter is that when they post selfies, the stars that we follow online are hardly in their natural state. False lashes adorn nearly every celebrity and social media star’s eyes.

So, while we’re talking about truths, let’s talk about some of the eyelash growth “methods” that’s just flat-out myths. From coconut oil for eyelashes to petroleum jelly and more you’ve probably heard about it all. Let’s get right now to the bottom of these common myths.

Here are 4 common myths about how your eyelashes are supposed to grow faster and longer.

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Myth 1: Use Vaseline On Your Lashes
This is a very common myth because Vaseline smearing on your lashes makes them all oily and glossy reflecting the light. This may seem as if some have grown their lashes. Yet petroleum jelly has very large molecules which, let alone the hair follicle, can not even penetrate the skin.

Simply, vaseline can not stimulate hair growth, and many reputable beauty therapists and ophthalmologists will beg you not to use it around your sensitive eye area. Vaseline is called petroleum jelly because, as you inferred, it is refined from petrol. Would you like to bring it so close to your eyes?

Vaseline can be a good dry skin barrier cream as it seals in moisture, but it can’t do more than just stay on the skin.

Natural oils such as castor oil and coconut oil have been called “miracle oils” in many blogs.

Myth 2: Apply Natural Oils To Your Lashes
Due to its low molecular size, Castor oil, unlike Vaseline, can easily penetrate deep into the skin. That’s right. But there is absolutely no credible clinical evidence linked with claims that castor oil can stimulate circulation and thus promote hair growth. Even if it is capable of nourishing the skin and hair, hair growth is not the same. The skin and hair are nourished by many beauty products.

Coconut oil is another intensely moisturizing product that can be a great remover of eye makeup. It is also shown to minimize hair protein loss and its fatty acids can protect hair from breakage.1 However, there is zero evidence to indicate that it may affect development.

Like Vaseline, coconut oil as well as castor oil are glossy and reflect light. A small bit brushed onto eyelashes might make them look fuller and longer, but it’s just an illusion.

Myth 3: Regularly Brush Your Lashes
Separating the lashes and brushing or combing the hair upwards will make them look neater and fuller–and, yes, much longer. But if you overdo it, you’ll probably take out more hair than you might be willing to fall out naturally.

Think about the phases listed above. Tugging constantly at the lashes in the telogen, and particularly during the catagen phases, will only cause them to fall out faster than if you were to handle them carefully.

Constant brushing and combing can also result in more hair shaft damage itself–which will definitely not help in longer lashes. When you feel the need to do so, stick to combine certainly.

Myth 4: Trim Your Lashes
Are you crazy?! Put down the sharp scissors! However, if you poke your eye out, the least of your concerns will be your lashes.

You don’t have to prune your eyelashes! Although some people believe that when it is regularly cut, the hair on their heads will grow faster, that too is a misconception. All cuts are neatening up the split ends that make hair look thicker and healthier.

Every hair has a naturally occurring growth cycle in four parts:

Anagen Phase: This is when hair is developing aggressively. From the hair follicle, the hair shaft is growing in length.

Telogen Phase: This is the stage of resting when the hair is still attached to the follicle but not growing. That length will remain until it sheds.

Catagen Phase: This is a brief period of rapid degeneration of the tissue. Just before the hair is shed, this process occurs. We are in the catagen process where the hair is naturally lost (without being pulled out).

Neogen Phase: The neogenic phase signals fresh regrowth after a hair shed to restart the cycle. The tissue and stem cells in and around the follicle strongly influence this process. Therefore, it is important to note that in this process your skin (which houses your hair follicles) also plays an important role.

Please note that at a certain length your eyelashes (like other hairs on your body) enter the phases of the telogen and catagen, and it is very unlikely you will do anything about this cycle. For the most part, eyelash development is written in your genetics.

Still, Want Thicker Lashes?
The Careprost eye drop is an ophthalmic component that is remotely used as a topical solution to the condition called eyelashes hypotrichosis. In order to make the flimsy, thin eyelashes soft, long and thick, a Careprost eye drop is effectively used along these lines. The reduction in the eye of Careprost is also a valuable treatment to recover glaucoma in patients. Buy Careprost 3ml as it is a beautiful prescription system designed to reduce hypotrichosis issues. This striking eye drop treats the slight and scanty condition of hypotrichosis eyelashes.

2 Oct 2020, 4:56am
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How to Get Longer and Thicker Eyelashes

Eyelashes and health
Eyelashes protect the eyes from light debris. These also serve as sensors warning the eyes of potential danger as things come near.

Sparse or thin eyelids fall under a condition called hypotrichosis eyelash. People with hair loss, called alopecia, occasionally experience eyelashes thinning.

If you’re trying to get lengthier and thicker eyelashes, you can use several home treatments.

Be cautious of these unproven remedies
A quick search on the web for “how to grow eyelashes” will yield a long list of home remedies. Nonetheless, none of these treatments are scientifically proven, and may even harm the eyes in certain situations.

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Some common home remedies which have not been scientifically proven to prolong eyelashes include:

Petroleum jelly: apply a small amount of petroleum jelly to the eyelashes before bed for at least three days a week, and wash it away in the morning.

Green tea: Apply cool unsweetened green tea with a cotton ball to the eyelashes every day.

Olive oil with or without lemon: apply a small amount of olive oil to the eyelashes at night before bed with or without lemon peel infused in it and wash it off in the morning.

Castor oil: Apply a small amount of castor oil to the eyelashes before bed every night and wash it off in the morning.

Aloe vera: Apply a small amount of aloe vera gel before bed to the eyelashes, and wash it off in the morning.

Eyelid massage: Massage eyelids along the lash line with a Gently massage.

A proven way to get longer eyelashes
The only accepted treatment for lengthening the eyelashes is to use the drug carefully.

Bimatoprost (Careprost) is the only US-approved drug. Food and Drug Administration (FDA), which makes eyelashes grow longer and thicker than ever before. It was originally developed to treat glaucoma as a medication called Lumigan, but researchers found that growth in eyelash was a side effect.

Your doctor may prescribe Careprost, that you regularly apply to the upper eyelid’s lash line (not the lower eyelid). Where used daily for at least two months, it provides full results. When you start using Careprost, you need to keep using it regularly to keep the results. Otherwise, the eyelashes will revert to their former state.

Careprost is safe and effective and has minimal side effects for most people. Possible side effects include:

itchy and red eyes
dry eyes
darkened eyelids
the darkened brown pigment in the iris (the colored part of the eye)
Hair growth on the face around the eyes if the medication is applied improperly to the eyelid
It’s very important to keep out of the eye drugs and other things that lengthen the eyelash. Extremely fragile skin. Having foreign substances in the eye may cause loss of vision and blindness in severe cases. You can Read how to apply careprost for eyelash growth

Grooming your eyelashes
Proper maintenance of the eyelashes will improve the health of your eyelashes, making them less likely to split. This can make them look lengthier and thicker. Few tips for grooming with the eyelash include:

brushing your eyelashes regularly with an eyelashes brush
Wash your face and eyes daily with gentle soap
At the end of each day remove eye makeup
There are many forms of home remedies that are meant to help grow one’s eyelashes, but none are proven effective or safe except for the eyelashes-lengthening drug Careprost approved by the FDA. It’s very important not to place potentially hazardous substances in or near your eyes. And if you’re using the medicine, you’ll need to make sure you keep it out of your eyes to prevent side effects.

2 Oct 2020, 4:18am
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Azelaic Acid Skin Care Benefits: All You Need to Know

Azelaic acid is an FDA approved skin care ingredient used for the topical treatment of acne and rosacea. Azelaic acid is antibacterial, meaning it kills acne bacteria in existing pimples. In fact, azelaic acid is so tough against acne bacteria that it’s an OTC option for treating cystic acne and has been studied to be almost as effective as Accutane. Azelaic acid 20% is a keratolytic meaning it exfoliates dead skin cells and is also a comedolytic meaning it prevents future whiteheads and blackheads from forming. Azelaic acid lightens acne scars as well as melasma, and it’s anti-inflammatory properties calm rosacea and redness. Even though azelaic acid is a powerful ingredient, it’s gentle on the skin and safe for all skin types. Azelaic acid is naturally occurring in whole grains like barley, wheat, and rye, but mostly synthetic versions are used in skincare products for greater stability and overall effectiveness.
Top 6 Azelaic Acid Skin Care Benefits

✓ Fights Acne Bacteria
GREAT FOR MODERATE TO SEVERE ACNE
A long-established ingredient, azelaic acid is best known for the treatment of acne. Azelaic acid is antibacterial meaning it works to kill acne bacteria, and unlike many other acids that fight acne (salicylic, glycolic, and alpha hydroxy acids), azelaic acid is an OTC options that’s actually strong enough to fight cystic acne. Azelaic acid combats acne by diving deep into your pores and decreasing the free fatty acid content in your skin. This creates a skin environment that’s less friendly to acne bacteria. There is also evidence that azelaic acid disrupts normal cellular function of acne bacteria, effectively killing it from the inside out.

✓ Safer than Accutane
GENTLER & NONTOXIC OPTION
Accutane is a branded, prescription acne medication which contains the acne fighting ingredient isotrentinoin (a derivative of Vitamin A). Even though Accutane is exceptionally effective at clearing severe, cystic acne, it comes at the risk of various side effects, some more serious than others. For example, Accuatane can cause skin irritation, dry skin and dry lips, but it also can cause birth defects (women who are pregnant or may become pregnant cannot be prescribed Accutane). For those looking for a strong acne treatment but without the scary side effects, azelaic acid is a safer option. In a comparison of azelaic acid cream to oral isotretinoin in the treatment of severe acne, researchers found that azelaic acid was almost as effective as isotrentinoin at treating severe acne with considerably less skin irritation and no risk of birth defects.

✓ Prevents Future Acne
KEEPS PORES CLEAN
Azelaic acid is a comedolytic meaning it prevents future whiteheads and blackheads from forming. By keeping pores clean, whiteheads and blackheads won’t develop from excess oil or dead skin cell buildup. FYI, salicylic acid and benzoyl peroxide are also comedolytics.

✓ Removes Dead Skin Cells
UNCLOGS PORES
Azelaic acid increases the turnover rate of dead skin cells, and as dead skin cells see their way off your face, your pores are left nice and clean. The scientific reason is azelaic acid has keratolytic properties (like ingredients salicylic acid and benzoyl peroxide). And why do we care? Having unclogged, clearer pores prevents future acne from developing.

✓ Lightens Melasma and Acne Scars
TREATS MILD HYPERPIGMENTATION
Azelaic acid lightens hyperpigmentation by reducing melanin production in hyperactive areas (darker spots on the skin). Azelaic acid limits melanin creation by inhibiting tyrosinase, an enzyme needed for the production of melanin in your skin. Fancy way of saying azelaic acid prevents the enzyme from doing its thing, and the melanin production line comes to a halt. Less melanin being created is what fades hyperpigmentation, especially dark areas not caused by the sun. All in all, the topical treatment of azelaic acid decreases melanin which fades hyperpigmenation like melasma and acne scars. Unfortunately, azelaic acid does not fade freckles or age/sun spots as effectively.

✓ Anti-Inflammatory
SOOTHES ROSACEA (REDNESS) AND ACNE
Azelaic acid is an anti-inflammatory, meaning less redness, pain, and swelling from acne, rosacea, or other types of inflammation. For acne-prone skin, azelaic acid calms breakouts and prevents new pimples from developing. For those with rosacea, azelaic acid calms redness by soothing the underlying inflammation that causes rosacea. Plus, azelaic acid is milder than other antibacterial agents, making it a prime ingredient to gently exfoliate and clean pores without irritating rosacea or sensitive skin in general.

2 Oct 2020, 4:17am
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The Ordinary vs Paula’s Choice: Azelaic Acid

Is this the new glycolic acid? I’ve been an avid user of useful acids for years now. I thought I had achieved a good balance in what I used, the concentrations I used and how often I used them. Hence, I hadn’t been looking for a new one to add to my routine. The consideration just wasn’t there and then azelaic acid came along.

To make this easier here is a breakdown of some important facts you’d need about the two best (in my opinion) azelaic acid products on the market right now. They are on either end of the spectrum (cheap and expensive).

The Ordinary Paula’s Choice
£5.50 for 30 mL £37.00 for 30 mL
10% azelaic acid azelaic acid 20%
Ingredients: Aqua (Water), Isodecyl Neopentanoate, Dimethicone, Azelaic Acid, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dimethyl Isosorbide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysilicone-11, Isohexadecane, Tocopherol, Trisodium Ethylenediamine Disuccinate, Isoceteth-20, Polysorbate 60, Triethanolamine, Ethoxydiglycol, Phenoxyethanol, Chlorphenesin. Ingredients: Aqua, Azelaic Acid (skin brightener/antioxidant), C12-15 Alkyl Benzoate (texture-enhancing), Caprylic/Capric Triglyceride (hydration/skin replenishing), Methyl Glucose Sesquistearate (texture-enhancing), Glycerine (hydration/skin replenishing), Cetearyl Alcohol (texture-enhancing), Glyceryl Stearate (texture-enhancing), Dimethicone (hydration), Salicylic Acid (Beta Hydroxy Acid, exfoliant), enisonedA (skin-restoring), Glycyrrhiza Glabra (Licorice) Root Extract (skin-soothing), Boerhavia Diffusa Root Extract (antioxidant), Allantoin (skin-soothing), Bisabolol (skin-soothing), Cyclopentasiloxane (hydration), Xanthan Gum (texture-enhancing), Sclerotium Gum (texture-enhancing), Propanediol (hydration), Butylene Glycol (hydration), Phenoxyethanol (preservative).
So, I’m gonna take a wild guess and assume your first questions is why is the price so different if the size and concentration is the same? The answer is down to the fact that Paula’s Choice doesn’t have too many other ingredients padding out the formula. Too many ingredients before azelaic acid can mean the affect of the acid can be reduced. Whenever I think about buying skincare I look at the first couple of ingredients. You’ll notice azelaic acid is NOT in the top three ingredients for The Ordinary version. However, Aqua (Water), Isodecyl Neopentanoate, Dimethicone are.

Aqua is the first ingredient for both, so lets say they cancel out. Dimethicone is an organic, silicon polymer which is widely used in skincare but can also be found in contact lenses and shampoo. It’s used to soften and moisturize the skin. Isodecyl Neopentanoate is also used in skincare for the same purpose.

Slightly off topic but something worth mentioning, I ADORE the way Paula’s Choice tells you why the ingredient is in the product, I.E Salicylic Acid (Beta Hydroxy Acid, exfoliant), enisoned A (skin-restoring). That’s all I’ve ever wanted from a brand – JUSTIFICATION. Justification means I understand what this will do for my skin and why it costs as it does.

Paula’s choice has provided this very clearly with this booster. Just the fact the azelaic acid is the second ingredient proves that it’s worth the extra money because you will be able to clearly see what affect the acid has on your skin. Also, I’m really glad to see some salicyclic acid in there to help boost the properties of the azelaic acid.

However, if your budget or skin curiosity doesn’t allow for something like the booster from Paula’s Choice than The Ordinary is a good place to start because it has the padding out from dimethicone that won’t allow the product to be too harsh on your skin. Plus, it’s only a fiver. If you’re looking to buy azelaic acid because you have intense acne and/or want to move away from using benzoyl peroxide, then Paula’s Choice will be worth the investment.

2 Oct 2020, 4:16am
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Acne Series: Mesoestetic Mesopeel Azelan

Next up in our “Acne Series” is the Mesoestetic Mesopeel Azelan. Long gone are the days where peels leave you with a red, sore and shedding post-peel face, Mesopeels are both gentle on the epidermis yet effective on areas of concern. This exclusive peel is formulated with a precise combination of chemical exfoliants to treat specific and common aesthetic disorders such as acne and acne scarring.

How Mesopeel Azelan works
Acne is characterised and graded accordingly starting with open and closed comedones, inflamed pustules, Seborrhoeic Dermatitis and acne scarring (depending on the severity and age of the scars). The Azelan treatment peel combines 20% Azelaic Acid with 20% Salicylic Acid, which can be used on all acne grades 1-4.

Azelaic Acid is an antibacterial agent with anti-inflammatory and oil-regulating properties to normalise the keratinisation process of the follicles.

Salicylic Acid is a Beta Hydroxy Acid (BHA) that penetrates pores to loosen clogged follicles by breaking apart dead skin cells, softening and helping them reveal smoother looking skin. It also has anti-inflammatory, anti-microbial, astringent and anti ageing properties.

Who is Mesopeel Azelan for?
The Mesopeel Azelan is specifically for acneic skin experiencing inflamed spots, blackheads, whiteheads, post-acne scarring, seborrhoea and rosacea.

The treatment is suitable for most skin types and to achieve the best possible results, we recommend the use of specific Mesoestetic home care products prior to treatment that are designed to replenish and strengthen the skin post-peel.

The treatment pack is fully explained by our expert clinicians and contains:

Mesoestetic Purifying Mousse Cleanser – this daily cleansing mousse deeply cleanses and purifies acne-prone skin to leave a fresh supple complexion.
Mesoestetic Acne One Treatment Cream – exfoliate, limit sebum production, control bacteria, reduce redness and p-acne bacteria.
Mesoestetic Pure Renewing Mask – exfoliate and purify oily and acne-prone skin whilst stimulating cellular renewal to keep skin clear and smooth.

How many treatments will I need?
As with all treatments at Face the Future, a consultation must be completed prior to treatment, allowing our expert clinicians to assess your skin concerns and make the best possible treatment recommendations for your skin. We usually recommend around 4-6 azelaic acid 20% sessions with minimum intervals of 2 weeks between treatments.

Does the treatment have any downtime?
Yes, patients tend to experience mild pink/redness after treatment and skin may feel warm. However this normally subsides within 24-48 hours.

After treatment we advise against any sun exposure or heat treatments for at least 24-48 hours, some flaking may occur and this is often more prevalent around the mouth and eye area. Skin may feel a little tight and swollen for 24-48 hours. And as always, it is important to use a broad spectrum SPF containing a high standard of UVA/UVB rated 50 or more.

2 Oct 2020, 4:14am
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A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA

Shifting views on the safety of drug substances at FDA are not uncommon with the advent of new scientific findings or upon better understanding of physiological processes or disease states. With time, these shifting views may manifest as differences in policies or requirements for drug approval. The most obvious cases highlighting changes in Agency thinking are reflected in new guidances or regulations, but these changes in perspective can also be reflected in more subtle ways, including the requirement for additional postmarketing commitments.

In the regulatory case that is the focus of this blog post, azelaic acid is used to highlight the changing views of the Dermatology review division of FDA related to the safety of products containing this active ingredient over the last 20 years, as well as what could be viewed as an overall shift in the Division’s perspective; with a trend towards more stringent requirements for dermal carcinogenicity testing of topical products.

Azelaic acid, a naturally occurring saturated dicarboxylic acid found in wheat, rye, and barley, possesses antimicrobial activity, affects keratin production, and reduces inflammation. Azelaic acid was first approved as a new molecular entity by FDA in 1995 as a topical cream (20%) produced by Allergan (Azelex®; NDA 020428). As a topical product, Azelex was approved by the Division of Dermatologic and Dental Drug Products (now referred to as the Division of Dermatology and Dental Products or DDDP) at FDA. According to the Division’s website, the mission of this DDDP is to regulate Investigational New Drug Applications, New Drug Applications, and Biologics Licensing Applications for drugs and biologics intended for the prevention and treatment of dermatology and dental conditions including:

Acne
Actinic keratosis
Aesthetic indications (facial lines, subcutaneous fat, scarring, etc.)
Atopic dermatitis
Condyloma acuminate (genital warts)
Dental caries
Gingivitis
Psoriasis
Rosacea
Superficial basal cell carcinoma
Wound healing/ulcers
Xerostomia (dry mouth)
Azelex is FDA-approved for the following indication: topical treatment of mild-to-moderate inflammatory acne vulgaris. Clinical trials for Azelex were performed for approval, although the details are not provided in the approved product labeling. Adverse effects associated with the use of Azelex are generally mild and transient, with the most common effects occurring locally. Azelex is a Pregnancy Category B product, representative of a demonstrated lack of risk in animal reproductive studies but an absence of adequate and well-controlled studies in pregnant women. There is low systemic absorption of azelaic acid from the drug product (~4% of a topically applied dose); additionally, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels following topical treatment with Azelex.

For approval of Azelex, carcinogenicity testing was not required. According to the approved product labeling: “Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity. Therefore, animal studies to evaluate carcinogenic potential with Azelex Cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic.”

Azelaic acid was approved as a new dosage form in 2002 – as a 15% topical gel product (Finacea®; NDA 021470; Bayer Healthcare) – by the Dermatologic and Dental Drug Products Division for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The application referred to much of the information included in the Azelex cream application and would normally have been considered a 505(b)(2) application; however, the sponsor had right of reference to all data with letters of authorization from Allergan, making the application a 505(b)(1) submission. From a pharmacokinetics standpoint, plasma levels of azelaic acid in patients were shown to be the same as those in subjects treated with vehicle alone (see approved product labeling).

Although the active ingredient in Finacea is the same as that of Azelex (azelaic acid) and is included at a lower concentration (15% vs. 20%), and while both products have low systemic absorption of azelaic acid, the approval of Finacea gel was contingent on a postmarketing commitment for a study to determine the photocarcinogenic potential of the product; with a dermal carcinogenicity study subsequently being required. In the Pharmacology Reviews for approval of Finacea gel (15%), the reviewer noted the discrepancy between the approved labeing of Azelex, which required no carcinogenicity testing, and that of Finacea stating that the Azelex labeling “does not incorporate the current state of knowledge” and that “it is not our current policy.” Once the data from the postmarketing studies were available, the approved product labeling for Finacea gel was updated to include the following:

“In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, Finacea gel and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, Finacea gel and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.”

Another azelaic acid product was approved last month by DDDP, Finacea emulsion aerosol foam (15%; NDA 207071; Bayer Healthcare Pharmaceuticals Inc.), for use in the same indication as Finacea gel (topical treatment of inflammatory papules and pustules of mild to moderate rosacea). However, the approval letter for Finacea foam states that the postmarketing requirement for approval is a 104-week dermal carcinogenicity study in CD-1 mice. Further information on the review of the Finacea foam application is not yet available, although it is likely that Bayer Healthcare Pharms utilized nonclinical data from the Finacea gel application (sponsored by Bayer Healthcare) as the nonclinical information included in the Finacea foam approved product labeling is the same as that of the gel product.

As the reviews for Finacea foam are not available, one can only speculate on the reasoning behind this more stringent requirement for dermal carcinogenicity testing of a product containing an active pharmaceutical ingredient that has been approved for topical use for 20 years; and further considering that the active pharmaceutical ingredient has not been overtly linked to carcinogenicity in the published literature. In fact, a search of the PubMed literature database suggests that azelaic acid has antitumor activity, at least in vitro. It is possible that the results of prior carcinogenicity testing required as a postmarketing commitment for the Finacea gel contributed to the presumptive change in testing requirement; increased papillomas in males (but not females) following twice daily dosing with Finacea gel likely contributed to the DDDP’s requirement for the 104-week dermal carcinogenicity study for this product. The clinical relevance of these findings, however, has not been established and reports of papillomas in humans are not described in the published literature or in the approved product labeling for Finacea or Azelex as adverse events or postmarketing findings. Pharmacokinetics from the approved product labeling of Finacea foam indicate that mean plasma concentration at steady state was similar to the values of subjects treated with Finacea gel and were within the range of the endogenous plasma concentrations of azelaic acid measured prior to treatment initiation; Foam Cmax: 51.8 ng/mL; Gel Cmax: 42 – 63.1 ng/mL; Endogenous plasma concentrations: < 1 – 105 ng/mL), suggesting that the peak concentrations of azelaic acid were not a cause for the DDDP’s increased safety concern.

The 20-year regulatory history of azelaic acid, a dietary component and endogenously formed substance that is minimally absorbed when included as the active ingredient in topical formulations, is a clear example of how product approval requirements can change over time, either with new information regarding the science of the drug substance or disease state or with shifting attitudes at the regulatory agency regarding the critical requirements for substantive product review. Essentially, the relative “bar” for safety of new approvals for established products, even with apparently adequate safety profiles, has been and is likely to continue to be raised for products under azelaic acid 20 cream reviews, as evidenced by azelaic acid.

2 Oct 2020, 3:50am
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