Cosmeceuticals

What is Cosmeceuticals?

Cosmeceuticals are products that are revolutionizing the personal care industry worldwide. Even though there’s some confusion about what they really are, it’s safe to say that they make up almost 30% to 40% of any skin doctor’s prescriptions worldwide. The term cosmeceutical, first introduced in 1984 by Dr. Albert Kligman, refers to products that fit somewhere between cosmetics and pharmaceuticals. Essentially, they are skincare products that deliver benefits similar to medicine, but not necessarily at the same intense level.

The use of cosmeceuticals has grown drastically. These include products developed for anti-aging, skin renewal, and a wide range of antioxidant-rich formulas. Cosmeceuticals are a new type of cosmetic products that deliver benefits beyond simple beauty enhancement, but they’re not potent enough to be classified as a drug or pharmaceutical.

One way to define cosmeceuticals is as cosmetic products that claim to have a beneficial therapeutic effect on the skin, providing benefits that extend beyond its application period. Interestingly, even though the term cosmeceutical is used frequently in the field of skin care, it still hasn’t been formally recognized by regulatory organizations like the United States Food and Drug Administration (US-FDA) or the European Union.

The not-so-clear definition of ‘cosmetics’ and ‘drugs’ is part of the reason why there’s confusion around cosmeceuticals. In terms of regulations, a drug is something that’s used to diagnose, treat or prevent disease, or to affect the body’s structure or function. A cosmetic product, on the other hand, is used only for cleansing, beautifying, or changing the appearance of the human body, without affecting its structure or function.

Without clear guidelines for cosmeceuticals, there can be consequences regarding important factors like product labeling, testing procedures, and approval for sale and distribution. For instance, in the U.S., unlike drugs, cosmeceutical manufacturers aren’t required to show that a product is safe or effective before selling it.

When it comes to classifying cosmeceuticals, it differs by region. In Europe and Japan, they’re considered a subclass of cosmetics, whereas in the U.S., they’re viewed as a subclass of drugs.

Regarding regulation and licensing, the process for cosmeceuticals should be less complicated than for drugs. However, clinical studies should demonstrate that the cosmeceutical can treat minor skin disorders and assure optimal safety without expected side effects.

The amount of an active ingredient can also complicate the differentiation between a drug and a cosmetic product. For instance, if a sunscreen product has a sun protection factor (SPF) below 4, it’s classified as a cosmetic. If it’s a higher SPF, it’s sold over the counter (OTC), like a drug.

For our purposes, we might consider a cosmeceutical to be a product that has some pharmaceutical activity, can be applied on normal skin, benefits minor skin disorders, and carries a low risk profile.

The term “nutraceutical” can be referred to as a product that comes from foods but is sold in the form of pills, powder, or other medicinal forms. Nutraceuticals are often sourced from natural herbs, food industry, and the pharmaceutical industry. When it comes to skin care, think of a nutraceutical as a product that is consumed orally and offers benefits similar to a cosmeceutical.

Indications for cosmeceuticals might include: anti-aging, treatment for skin tone issues and pigmentation disorders like melasma or freckles, wrinkle reduction, anti-inflammatory, fat loss, hair growth and fall prevention, and maintaining skin tone and clarity.

What Causes Cosmeceuticals?

Cosmeceuticals are substances that have both cosmetic and therapeutic (medical or drug-like) benefits. Because cosmeceuticals aren’t strictly defined, they are generally classified based on the problem they are meant to address or what they are made from or how they are structured.

Here are some common categories of cosmeceuticals, organized by their primary uses:

1. Lightening or removing skin pigment
2. Sunscreens
3. Moisturizers
4. Anti-wrinkle/aging products
5. Treatments to reduce scars
6. Antioxidants
7. Products to strengthen hair
8. Products made specifically for certain disorders like acne, rosacea, or melasma
9. Other miscellaneous products

There are many cosmeceuticals available, and they often come in a variety of forms like tablets, creams, or oils for oral use or application directly to the skin. Here are several examples:

• Alpha-lipoic acid (taken orally)
• Coenzyme Q10 (taken orally)
• Vitamin B-complex (taken orally)
• Vitamin C (taken orally and applied topically)
• Hydroquinone (applied topically)
• Retinoids (taken orally)
• Comfrey (applied topically)
• Licorice (applied topically)
• Turmeric (both topical and oral)
• Aloe vera (both topical and oral)
• Hyaluronic acid
• Allium cepa
• Panthenol (applied topically)

This is not a comprehensive list; rather, it is just a sample of the types of substances that are commonly used in cosmeceuticals.

Risk Factors and Frequency for Cosmeceuticals

People around the world are increasingly wanting to look good, feel young, and stay healthy. According to global research, sales of natural product-based cosmetics and personal care products, otherwise known as cosmeceuticals, reached nearly $3 billion in 2015. This particular segment has been growing at a rate of 4% annually over the past five years.

In India, the cosmetics market is valued at around 356 billion INR, or Indian Rupees. The Indian beauty and cosmetics industry has been consistently growing between 15% and 20% every year.

While women are the main buyers of cosmeceuticals, more and more men begin to use these products. The rise of this trend has largely been influenced by media exposure and attractive advertising, as well as the spread of corporate dressing culture. This culture was primarily seen in the West, but it’s now becoming more common in the Asia-Pacific region as well. Moreover, an increase in consumers’ purchasing power plays a significant role in this trend.

Alongside the growth in the market, new and innovative technology has been developing to produce safer and more effective cosmeceuticals. Products incorporating nanotechnology, penetration enhancers, stabilizers, and special ingredients are becoming more common.

Many leading companies are exploring ways to test their products more conveniently. Some are developing product formulations that can be tested on 3D printed live human tissue, eliminating the need for extensive and expensive animal and human trials.

Testing for Cosmeceuticals

The process of getting active ingredients from products like beauty products, especially those sourced from organic materials like sea extracts, depends on how the ingredients are extracted. The outcome, quality, and effectiveness of the product largely hinges on how well the extraction process is carried out. The process could be affected by several factors like the physical and chemical traits of the source material, the type and strength of the solvent used for extraction, and the environment in which the extraction takes place, such as the temperature and pressure.

Extraction methods are usually divided into classic methods and modern methods. The classic or conventional methods include techniques such as hydro-distillation, Soxhlet extraction, maceration, percolation, infusion, decoction, and continuous hot extraction. Among these conventional methods, Soxhlet extraction technique is traditionally used for extracting substances from plant or marine sources, though it is a time-consuming process.

More recently, modern techniques have been developed to overcome the shortcomings of the conventional methods, such as the need for highly pure solvents, low success rates in extraction, degradation of heat-sensitive ingredients, and long periods required for extraction. These new technologies, which include superficial-fluid extraction, pressurized-liquid extraction, enzyme-assisted extraction, and microwave-assisted extraction, are also environmentally friendly, making them ‘green’ choices.

When assessing the quality of a beauty product, Dr. Albert Kligman—considered the father of beauty products—proposed answering three important questions: (1) Can the active ingredient get past the outer layer of the skin in enough quantity and over a timespan consistent with how it works? (2) Does the active ingredient have a known specific biochemical role in the target cell or tissue in human skin? (3) Are there published, double-blind, peer-reviewed, placebo-controlled, statistically significant clinical trials to confirm the effectiveness of the products?

It is challenging for certain substances to penetrate the outer layer of the skin, known as the stratum corneum, due to its function as a barrier to prevent water loss. Certain substances, especially those that are large molecules over 1000kDa and those that are highly charged, find it difficult to cross this barrier.

To evaluate how well an active ingredient can penetrate the skin barrier, researchers can use three types of studies: in vitro (in a lab setting), ex vivo (outside an living organism, such as organs or biological tissues), and in vivo (inside a living organism).

In addition to crossing the skin barrier, beauty products must reach a specific target in the skin to deliver effects. This is determined using a variety of bioengineering techniques.

Lastly, to back up the claims made for a product, clinical trials are conducted. The best trials are those that use noninvasive tools to measure parameters like the effect of the product on reducing water loss, skin water content, elasticity, color, and other factors regarding skin improvement. High-quality trials also involve large participant groups, control groups, random assignments, statistical analyses, and defined measures of outcomes. Besides inspecting tissues under a microscope, other preferred methods of examination include dermoscopy and confocal microscopy because they are noninvasive.

Treatment Options for Cosmeceuticals

Cosmaceuticals, also known as cosmetic products with pharmaceutical benefits, are used for a wide range of skin and hair care purposes. These include:

1) Lightening the skin or helping reduce the appearance of skin pigmentation.

2) Providing protection from the sun’s harmful rays as sunscreens.

3) Helping keep the skin moisturized.

4) Assisting in combating the visible signs of aging, such as wrinkles.

5) Aiding in reducing the appearance of scars.

6) Contributing antioxidant effects, which help protect the skin from damage by substances called free radicals.

7) Strengthening hair, preventing hair fall, encouraging hair growth, and improving hair texture.

8) Treating specific skin conditions such as acne, rosacea, or melasma.

9) And various other uses in skin and hair care.

What else can Cosmeceuticals be?

There are several conditions that might look similar to each other, so it’s important to get the right diagnosis. These conditions could include:

• Atopic dermatitis (a type of eczema)
• Contact dermatitis (skin reaction from contact with certain substances)
• Drug eruption (rash caused by a drug reaction)
• Erythema infectiosum (also known as Fifth disease, a viral infection common in children)
• Erythema multiforme (a skin reaction often due to infection or medication)
• Folliculitis (inflammation of hair follicles)
• Guttate psoriasis (a type of psoriasis characterized by small, red, scaly spots)
• Insect bites
• Keratosis pilaris (small, rough patches of skin)
• Nummular eczema (a type of eczema characterized by round patches of itchy skin)
• Tinea corporis (ringworm)
• Urticaria (hives)

Getting the correct diagnosis is crucial for finding the best treatment strategy.

What to expect with Cosmeceuticals

Predicting the results of a specific skin condition with cosmeceuticals, or skincare products with ingredients that can improve skin health, isn’t always straightforward. This is because everyone’s skin reacts differently to various topical treatments. The likelihood of a treatment’s success can also be influenced by several factors.

For example, if a patient is using cosmeceuticals for a skin condition called melasma, which is often seen as dark, discolored patches on the face, the following could affect the treatment’s outcome:

1) Disease characteristics: Factors like how deeply the melasma penetrates into the skin, the activity of the pigment-producing cells (melanocytes), and whether medications like hormonal pills might counteract the effects of the treatment, can all impact the results.

2) Patient factors: The sensitivity and tolerance of the patient’s skin to the treatment, how consistently they stick to the recommended usage, how thoroughly they protect their skin from the sun, and whether they can afford to maintain the treatment long-term are all important considerations.

3) Cosmeceutical factors: The treatment’s quality, how similar different brands are, the cost, how well it works, how well it’s tolerated, and the potential for long-term side effects all need to be considered.

Therefore, it is crucial to tailor cosmeceutical use to the specific needs of each individual patient, taking into account all of these factors.

Tools like dermoscopy, which helps in examining the skin, may assist in choosing a cosmeceutical based on a patient’s specific condition. For example, melasma with brown pigmented structures might respond well to short-term use of moderate-strength cosmeceuticals, while stronger treatment may be necessary for deep melasma. Newer melasma cases with noticeable blood vessel changes might improve more with treatments containing tranexamic acid, rather than hydroquinone, which is commonly used to lighten the skin.

Possible Complications When Diagnosed with Cosmeceuticals

Despite the potential for serious complications like severe allergic reactions, skin burns, and persistent inflammatory hyperpigmentation, or milder, temporary ones like skin irritations and allergies due to contact with certain substances, complications from most skin-care products are rare. Ensuring they’re used moderately and following the doctor’s advice and necessary precautions can generally keep any issues at bay.

Common Side Effects:

• Severe allergic reactions
• Skin burns
• Dark spots on the skin due to inflammation
• Temporary skin irritations
• Skin allergies from direct contact with substances

Preventing Cosmeceuticals

1) It’s important for patients to understand that skincare goods, referred to as ‘cosmeceuticals’, are not the same as medical treatments; they can’t replace medicated creams. These skincare products could take longer to show noticeable improvements on your skin.

2) A common concern for skin doctors is when patients come to them for improving skin quality or hair loss, and ask about brands they’ve used before. The doctor tries to check the ingredients in the creams, lotions, or other products you’ve been using. They might allow or stop your usage, based on your skin condition, your tolerance, and how these products might affect the medicinal creams they plan to prescribe. It’s also key to remember these products can be expensive. So, the doctor will suggest products that are reasonably priced but effective. They will usually have an idea of how long it should be used for. Depending on the progress or if other treatments such as oral medication or skin treatments (like skin peels/laser toning) are planned, changes may need to be made.

3) There is another point to consider about the cost of these products – sometimes patients want to keep using pricey skincare items they’ve received as gifts or bought themselves. It’s important that the doctor explains to the patient what will help their condition and what may not.

4) There are instances when patients blame a new problem, like acne, on these products. If the doctor believes that this reaction didn’t occur because of the recommended product, they will usually monitor the situation. If it gets worse, all applications are stopped and a small skin test may be conducted. For those with sensitive skin, any new product should be first tested on a small skin area for 2-3 days. If it’s well tolerated, your doctor will recommend continuing its use. For certain situations, particularly with products known as retinoids and lotions with Alpha Hydroxy Acids, patients with sensitive skin are advised to apply the product for short periods (5-15 minutes) and then rinse off, followed with plenty of moisturizer.

5) Consistency with treatments –Patients should consistently use all prescribed medicines. It’s not uncommon for patients to forget to apply sunscreen during the day while using retinoids at night, which can lead to unexplained skin reactions like redness, worsened by sun exposure.

6) Hidden product use/salon treatments – The doctor needs to ensure (especially when using stronger treatments like retinoids) that the patient isn’t also using other undisclosed skincare products. This can include astringents, toners, salicylic acid-based face washes, or receiving salon treatments like facials, bleaching, ‘cleansing’ etc. These treatments might lead to complications, which the patient could wrongfully attribute to the doctor’s treatment, instead of their own skincare routine.