Phymatous Rosacea: Causes, Symptoms, and Treatment

Nikki Chase

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Phymatous Rosacea: Causes, Symptoms, and Treatment

Phymatous Rosacea (PPR) is a chronic skin condition characterized by thickened skin, enlarged pores, and visible blood vessels around the nose, leading to a condition known as rhinophyma. The type of rosacea progresses over time, with symptoms worsening if left untreated. The exact causes of Phymatous Rosacea are not fully understood, but genetic, environmental, and immune system factors are believed to play a role. Patients with Phymatous Rosacea experience flare-ups triggered by environmental stressors (sun exposure, extreme temperatures, and foods or beverages).


Phymatous Rosacea treatment includes topical medications (metronidazole and azelaic acid) to reduce inflammation and redness. Oral antibiotics (doxycycline) are prescribed to address more severe inflammation. Laser therapy and intense pulsed light treatments are used to reduce redness and skin thickening in cases of advanced Phymatous Rosacea. Lifestyle modifications (avoiding known triggers and using gentle skincare products) help control the condition and prevent flare-ups.

What is Phymatous Rosacea (PPR)?


A Phymatous Rosacea (PPR) is a subtype of rosacea characterized by skin thickening, irregular surface nodularity, and enlargement of facial features, a condition known as rhinophyma. The progression arises from chronic inflammation associated with earlier rosacea stages, (erythematotelangiectatic) or papulopustular rosacea. The PPR presents with hyperplasia of sebaceous glands, fibrosis, and dilation of hair follicles, contributing to the characteristic skin changes.


The condition affects men over 50 years of age and is less common in women. Factors (genetics, immune system dysfunction), and environmental triggers (sun exposure and heat) contribute to its development, while the exact cause remains unknown. Treatment options include topical medications (isotretinoin and surgical interventions), laser therapy, or dermabrasion to reduce skin thickening and improve appearance. 


How is Phymatous Rosacea classified as Rosacea Type 3?


Phymatous Rosacea is classified as Rosacea Type 3 by dermatologists due to its characteristic thickening of the skin affecting the nose, which results in rhinophyma. The stage represents a more severe form of rosacea, where the skin becomes coarse and enlarged, showing visible irregularities. The main clinical features include a swollen appearance, with visible blood vessels and an orange-peel texture around the cheeks, chin, and nose. It is most seen in men, with an onset after the age of 30, but it affects women less frequently.


The pathophysiology of type 3 rosacea is believed to be linked to overactivity of the sebaceous glands and chronic inflammation, leading to the enlargement of the glands and subsequent tissue fibrosis. The condition worsens without treatment, leading to more noticeable deformities of facial features. Medical management includes oral antibiotics, topical treatments (retinoids), and laser treatments to remove the excess tissue and improve skin appearance. Dermatologists recommend early intervention to prevent progression and provide long-term relief.


How is Phymatous Rosacea Different from Other Types of Rosacea?


The differences between Phymatous Rosacea and Other Types of Rosacea are listed below. 


  • Erythematotelangiectatic Rosacea is characterized by facial redness, flushing, and visible blood vessels, referred to as the vascular form of rosacea. It is one of the rosacea types that focuses on the dilation of blood vessels, leading to persistent redness on the cheeks, nose, and chin. The subtype does not involve skin thickening or tissue changes, unlike Phymatous Rosacea. Different types of rosacea with pictures help in visually distinguishing the form from the other rosacea types, ensuring accurate diagnosis and treatment.

  • Papulopustular Rosacea is marked by acne-like breakouts, including red bumps (papules) and pustules on the face, affecting the cheeks, forehead, and chin. The subtype resembles acne more than other rosacea types, but unlike Erythematotelangiectatic Rosacea, it involves inflamed lesions. Phymatous Rosacea differs in that it leads to skin thickening rather than breakouts. The difference is the presence of papules and pustules without the thickened skin typical of Phymatous Rosacea.

What do Phymatous Rosacea Look Like?


Phymatous Rosacea looks like a severe, advanced form of rosacea characterized by thickened, bumpy skin and enlarged pores, leading to noticeable facial disfigurement. The subtype affects the nose, causing a condition known as rhinophyma, but it involves the chin, forehead, ears, and eyelids. The skin appears red, yellow, or waxy, with a rough, uneven texture resembling an orange peel. It is due to enlarged sebaceous glands and dilated hair follicles.


The skin becomes increasingly bulbous and distorted as the condition progresses, leading to functional issues when nasal passages are obstructed. Phymatous rosacea pictures clearly demonstrate the skin’s thickening and the enlarged facial features that are characteristic of the stage. The patients are asking if what does rosacea look like at that stage, as it is distinct from earlier forms, as it involves tissue changes rather than redness or acne-like lesions.

The Phymatous Rosacea is shown in the image below. 



What Causes Phymatous Rosacea?

What Causes Phymatous Rosacea?

The factors that cause phymatous Rosacea are listed below. 


  • Genetics: Genetic predisposition plays a role in the development of Phymatous Rosacea. Patients with a family history of rosacea develop the subtype. It is believed that genetic factors influence the skin's response to environmental and internal triggers.

  • Immune System Dysfunction: Immune system irregularities contribute to the chronic inflammation seen in Phymatous Rosacea. The body’s immune response causes the skin to react abnormally to harmless stimuli. The dysfunction leads to persistent inflammation, which accelerates skin changes and thickening.

  • Environmental Factors: Exposure to environmental factors (sunlight, wind, and extreme temperatures) worsens Phymatous Rosacea. The elements trigger flare-ups, contributing to the worsening of skin conditions. Patients with Phymatous Rosacea find that environmental stressors intensify their symptoms.

  • Overactive Sebaceous Glands: Overproduction of sebum by sebaceous glands is a major factor in Phymatous Rosacea. The excess oil clogs pores and leads to inflammation. Skin thickening and irregularity develop as sebaceous glands become enlarged.

  • Bacterial Infections: The presence of bacteria (Bacillus oleronius) contributes to the development of Phymatous Rosacea. The bacteria are thought to trigger an immune response that promotes inflammation. The inflammatory process is one of the key mechanisms behind the tissue changes in Phymatous Rosacea.

  • Blood Vessel Abnormalities: Blood vessels become dilated and more visible in Phymatous Rosacea. Abnormalities in blood vessel function contribute to the redness and skin irritation. The vessel changes are one of the first signs of rosacea and play a role in advancing to more severe forms (Phymatous).

  • Hormonal Changes: Hormonal fluctuations in menopause, pregnancy, or puberty trigger Phymatous. Changes in hormone levels increase skin sensitivity, leading to inflammation and the thickening of skin. The hormonal imbalance is a factor in the onset and progression of rosacea.

  • Dietary Factors: Foods and drinks (spicy foods, alcohol, and hot beverages) trigger or worsen Phymatous. The items are known to dilate blood vessels, intensifying redness and inflammation. Dietary modifications help reduce flare-ups for patients with Phymatous.

  • Stress: Emotional and physical stress is a well-known trigger for rosacea flare-ups, including Phymatous. Stress worsens inflammation and increases the production of substances that irritate the skin. Managing stress helps reduce the severity and frequency of rosacea outbreaks.

  • Cosmetic Products: The use of harsh or irritating cosmetic products contributes to the development of Phymatous. Skin-care products with alcohol, fragrances, or astringents inflame sensitive skin. The products lead to increased irritation and accelerate the progression of rosacea to its more severe stages.

What Triggers Can Worsen Early Phymatous Rosacea?


The triggers that can worsen early phymatous rosacea are sun exposure, which dilates blood vessels and exacerbates symptoms, and hot weather, which increases skin sensitivity and blood flow, triggering flare-ups. Factors that cause increased blood flow to the skin’s surface, leading to inflammation and skin thickening. Manage the triggers to prevent the condition from progressing into early phymatous rosacea. Emotional stress, cold weather, and wind worsen symptoms, in addition to environmental factors. 


Stress activates the immune system and leads to inflammation, while cold air and wind cause irritation and dryness, triggering rosacea flare-ups. Medications that dilate blood vessels, and harsh skin care products containing alcohol or fragrances, worsen early phymatous. 


Managing the triggers with lifestyle adjustments and skincare precautions is essential for controlling the phymatous rosacea early signs. Physical exercise worsens early phymatous rosacea because it increases body heat and blood flow to the facial areas. Hot drinks (coffee and tea) trigger symptoms by raising the body temperature. Spicy foods containing capsaicin cause blood vessel dilation and worsen redness.


Alcohol consumption is another common trigger that causes facial flushing and inflammation. Hormonal changes in menopause or pregnancy increase skin sensitivity and trigger flare-ups. Poor sleep patterns weaken the immune system and make symptoms worse. Medications for high blood pressure trigger episodes by affecting blood vessel function.


What Causes Rosacea Skin Thickening in Patients with Phymatous Rosacea?


The factors that cause rosacea skin thickening in patients with phymatous rosacea are chronic inflammation, sebaceous gland hyperplasia, and vascular abnormalities. The factors lead to the progressive thickening and fibrosis of the skin. The results in the characteristic features of phymatous rosacea (enlarged pores, bumpy texture, and nose skin thickening).


Sebaceous gland hyperplasia contributes to the enlargement of sebaceous glands and the dilation of hair follicles, leading to the thickened skin observed in phymatous rosacea. Vascular abnormalities, including increased blood flow and the formation of new blood vessels, worsen inflammation and contribute to skin thickening rosacea. The factors result in the progressive changes seen in phymatous rosacea, emphasizing the importance of early diagnosis and management to prevent irreversible skin alterations. Environmental damage from years of sun exposure worsen the condition by breaking down collagen and elastin in the skin.


The overproduction of inflammatory proteins causes tissue damage and scar formation over time. Demodex mites living in hair follicles contribute to ongoing skin thickening that leads to changes. Poor blood circulation in affected areas slows healing and worsens tissue damage. Hormonal imbalances affect skin cell growth and repair processes, causing thickening to occur more often.


What Causes Enlarged Pores in Patients with Phymatous Rosacea?


Enlarged pores in patients with phymatous rosacea are caused by increased sebum production, sebaceous gland enlargement, and persistent inflammation. The rosacea enlarged pores are a result of the dilation of hair follicles and sebaceous glands, which become more noticeable with the progression of rosacea. The accumulation of sebum clogs the enlarged pores, leading to their visible enlargement, in the areas of the nose, which is affected by nose skin thickening.


The chronic inflammation seen in phymatous rosacea leads to the thickening of the skin and the hypertrophy of sebaceous glands, which contribute to enlarged pores. The excess oils that stretch and enlarge the pores make the sebaceous glands overactive. Managing rosacea enlarged pores treatment involves controlling inflammation, reducing sebum production, and maintaining a proper skincare routine to prevent pore blockage and enlargement.

Can Cetyl Alcohol for Skin Help Prevent Phymatous Rosacea Causes?


Yes, Cetyl Alcohol for skin can help prevent Phymatous Rosacea caused by supporting the skin barrier with emollient properties that reduce dryness, irritation, and chronic inflammation linked with tissue thickening. 


Its soothing effect lowers the risk of ongoing irritation that contributes to phymatous changes, while providing stability in topical formulations. The Cetyl Alcohol for Skin plays a role in keeping rosacea-prone skin balanced and less reactive.

Is Skin Barrier Dysfunction in Phymatous Rosacea Similar to Atopic Dermatitis


Yes, skin barrier dysfunction in phymatous rosacea is similar to atopic dermatitis in terms of the impairment of the skin’s protective functions. The skin barrier is compromised due to mutations in genes responsible for producing filaggrin, a protein essential for maintaining the skin’s structure. The defect leads to an increase in transepidermal water loss (TEWL), which makes the skin dry, irritated, and more susceptible to allergens, irritants, and microbes. The compromised barrier function in atopic dermatitis creates a cycle of inflammation.


Skin barrier dysfunction in phymatous rosacea results from chronic inflammation, which causes the skin’s surface to become less effective at protecting against external irritants. The skin thickens and the sebaceous glands enlarge as the condition progresses, disrupting the natural barrier. It leads to increased sensitivity and vulnerability in atopic dermatitis, where an impaired barrier function makes the skin prone to flare-ups, irritation, and bacterial colonization. The conditions of managing inflammation and restoring the skin’s natural barrier are essential components of treatment.

What are the Symptoms of Phymatous Rosacea?


The symptoms of phymatous rosacea are skin thickening around the nose, leading to the condition known as rhinophyma. The thickening causes the skin to appear bumpy, enlarged, and irregular in texture, resembling an orange peel.


The affected areas have visible blood vessels, and the skin develops a waxy or rough texture. The changes occur over time, making the condition progressively more noticeable.


Phymatous rosacea causes swelling and enlargement of other facial features (chin, forehead, and ears), in addition to nose skin thickening. The condition causes the skin to feel sensitive and inflamed, with redness that persists even without flare-ups. The patients experience ocular symptoms, including dry eyes or irritation, as rosacea affects the eyelids and the area around the eyes, but it is not common. The symptoms impact a person’s appearance and require medical intervention to manage effectively.


What is the Difference Between Mild Phymatous Rosacea and Severe Bulbous Nose Rosacea


The difference between Mild Phymatous Rosacea and Severe Bulbous Nose Rosacea is tissue involvement and functional impairment of skin thickening.


Mild Phymatous Rosacea is characterized by early signs of skin thickening and irregular surface nodularities affecting the nose. The stage presents with changes (slight enlargement, visible pores, and a bumpy texture), without distortion of facial features. Treatment at that stage involves topical therapies and lifestyle modifications to manage inflammation and prevent progression.


Severe Rosacea on face or rhinophyma is marked by skin thickening, distinct nodularities, and enlargement of the nose. The advanced stage leads to a bulbous, distorted appearance of the nose, accompanied by functional issues (breathing difficulties) due to airway obstruction. Management of severe cases require surgical interventions, including laser therapy, electrosurgery, or dermabrasion, in addition to systemic treatments (oral isotretinoin) to address the underlying inflammation and prevent tissue damage.


Why is Rhinophymatous Rosacea more Common in Men?


Rhinophymatous rosacea, or bulbous nose rosacea, is more common in men due to a combination of genetic, hormonal, and physiological factors. Men have larger sebaceous glands, which produce more oil and are more prone to becoming enlarged and inflamed in rosacea. The overactive oil production contributes to the development of rhinophyma, as the enlarged sebaceous glands and hair follicles lead to thickening and irregularities in the skin. Hormonal differences between men and women, with higher levels of testosterone, influence the development and progression of rhinophymatous rosacea.


Men do not seek early treatment for rosacea, allowing the condition to progress to its more severe forms (rhinophyma). Women tend to experience rosacea differently, with symptoms more commonly affecting the face without leading to the tissue changes seen in men. The higher prevalence of rhinophymatous rosacea in men is thought to be linked to the factors, combined with the tendency for the condition to worsen over time without intervention.


How does Cetearyl Alcohol for Skin Soothe Symptoms of Phymatous Rosacea?


Cetearyl Alcohol for skin soothes symptoms of Phymatous Rosacea by increasing the skin barrier, providing emollient hydration, and reducing surface roughness that worsens thickened tissue. Its blend of cetyl and stearyl alcohol delivers a creamy texture in formulations that calm irritation while preventing excessive dryness, helping to limit structural changes linked with phymatous rosacea. The Cetearyl Alcohol for Skin supports comfort and barrier strength in sensitive conditions.


What Medical Treatments are Available for Phymatous Rosacea?


The Medical Treatments that are Available for Phymatous Rosacea are listed below.


  • Topical Retinoids: The medications (tretinoin) help reduce inflammation, unclog pores, and improve the texture of the skin by promoting skin turnover. The medicines are used in mild cases to prevent the progression of the condition.

  • Surgical Interventions: Procedures (dermabrasion, electrosurgery, or surgical excision) are required to remove excess tissue and reshape the affected areas, in severe cases, where skin thickening leads to distortion of facial features.

  • Cryotherapy: Cryotherapy uses freezing temperatures to treat localized areas of thickened skin. It is effective for removing excess tissue and improving the skin's appearance.

  • Radiofrequency Treatment: The treatment uses heat energy to target and shrink the enlarged sebaceous glands in the skin, helping to reduce the thickening seen in Phymatous Rosacea.

  • Topical Calcineurin Inhibitors: Medications (tacrolimus or pimecrolimus) reduce inflammation and control flare-ups by suppressing the immune response, offering an alternative to steroids.

  • Botox Injections: Botulinum toxin injections help reduce redness and inflammation by calming overactive blood vessels, while not a direct Phymatous Rosacea treatment, offering relief for some patients.

  • Dietary Changes: Dietary changes help manage rosacea symptoms, but are not a traditional medical treatment. Avoiding triggers (spicy foods, alcohol, and hot beverages) reduces flare-ups and helps keep the condition under control. 


How is Rosacea Nose Treatment Done with Laser Surgery?


Rosacea Nose Treatment is done with laser surgery through the use of high-powered lasers that target and remove excess tissue caused by rhinophyma. The lasers (CO₂ and Erbium YAG lasers) are considered the gold standard for treating the thickened skin and bulbous appearance characteristic of phymatous rosacea nose. The procedure involves vaporizing the enlarged sebaceous glands and reshaping the nasal tissue to restore a more natural contour. Laser surgery offers a minimally invasive approach with controlled precision, minimizing damage to surrounding healthy tissue.


The affected area is numbed using local anesthesia to ensure patient comfort in the treatment. The laser energy is then applied to the targeted tissue, effectively reducing the size of the thickened skin and improving the appearance of the nose. Recovery time varies depending on the extent of the treatment and healing processes, but most patients experience minimal downtime. Laser surgery for rhinophyma rosacea nose improves cosmetic outcomes, but eases functional issues (impaired breathing) associated with the condition.

Why is Stearyl Alcohol for Skin Considered Safe in Phymatous Rosacea Treatment?


Stearyl Alcohol for skin is considered safe in Phymatous Rosacea treatment because it belongs to the group of fatty alcohols that help to lock in moisture and strengthen the barrier without causing the irritation linked with drying alcohols.


The soothing and stabilizing properties make it suitable for formulations aimed at reducing inflammation and supporting thickened, sensitive skin. The Stearyl Alcohol for Skin is used to provide hydration and comfort in rosacea care.

What Skincare Practices Help Manage Rosacea Skin Thickening?

What Skincare Practices Help Manage Rosacea Skin Thickening?

The Skincare Practices that Help Manage Rosacea Skin Thickening are listed below.

 

  • Topical Medications: Topical medications (azelaic acid) help reduce inflammation and bacteria on the skin’s surface, addressing the causes of rosacea skin thickening. The medicines are prescribed to manage the initial signs of rosacea, preventing skin damage and thickening.

  • Oral Antibiotics: Oral antibiotics (doxycycline and minocycline) are used to control inflammation and bacterial overgrowth in moderate to severe cases of rosacea. The antibiotics work to reduce flare-ups and prevent skin thickening by targeting the causes of inflammation deep within the skin.

  • Laser Therapy and Intense Pulsed Light (IPL) Treatments: Laser therapy and IPL treatments are effective in targeting and reducing the visible blood vessels and thickened skin associated with rosacea. The procedures help shrink the sebaceous glands and improve skin texture, offering relief from rosacea skin thickening and reducing the appearance of redness and swelling.

  • Brimonidine Gel: Brimonidine gel is a topical treatment that works by constricting blood vessels, which helps reduce the redness caused by rosacea. The gel provides fast-acting relief for flushing and helps manage the early signs of rosacea without affecting the deeper skin layers.

  • Isotretinoin: Isotretinoin is an oral medication used for severe cases of rosacea that have not responded to other treatments. It reduces sebum production and shrinks sebaceous glands, which helps control the skin thickening and inflammation of phymatous rosacea.

  • Proper Skincare Routine with Gentle Products: Using an appropriate routine of skincare with gentle products is essential for patients with rosacea, as harsh cleansers irritate the skin. Gentle, fragrance-free products help maintain the skin’s protective barrier and reduce flare-ups that contribute to skin thickening.

  • Avoidance of Known Triggers: Avoiding known triggers (spicy foods, alcohol, and weather conditions) helps prevent flare-ups and skin damage. Identifying and eliminating triggers for managing rosacea and preventing the progression of rosacea skin thickening.

  • Moisturizers for Sensitive Skin: Moisturizers for sensitive skin help maintain hydration and protect the skin from external irritants, which worsen symptoms. Regular use of the Skin Care Routine for Rosacea helps keep the skin barrier intact, reducing irritation and preventing skin thickening.

  • Sunscreen with High SPF: Using sunscreen with high Sun Protection Factor (SPF) is essential for protecting sensitive skin from the harmful effects of Ultraviolet (UV) radiation. Daily application of sunscreen helps prevent flare-ups caused by sun exposure, a common trigger for rosacea, and protects against skin damage and thickening.


What are the Best Product of Era Organics for Rosacea?


The best products of Era Organics for Rosacea are listed below. 


  1. Rosacea Cream: The cream combines manuka honey, MSM, chamomile, and aloe vera to reduce redness and irritation associated with rosacea. It is free from sulfates, parabens, and fragrances, making it suitable for sensitive skin and effective for reducing flare-ups.

  2. Manuka Honey Gentle Face Wash: A sulfate-free face wash enriched with manuka honey and aloe vera that gently cleanses without stripping the skin’s natural moisture. It helps maintain the skin’s barrier while removing impurities, making it ideal for rosacea-prone skin.

  3. Face Moisturizer Cream: A deeply hydrating moisturizer containing manuka honey and hyaluronic acid, designed to nourish dry and sensitive skin. The product provides 12-in-1 benefits, including hydration, protection, and skin repair, making it suitable for daily use.

  4. Hypochlorous Acid Spray: A medical-grade spray that mimics the body’s natural immune response, helping to soothe inflamed skin and balance pH levels. The acid spray from Era Organics is beneficial for calming rosacea flare-ups and is used throughout the day for immediate relief.

An effective skincare routine results in clearer, smoother skin with improved hydration and minimal breakouts. Signs of a wrong routine include persistent irritation, dryness, excessive oiliness, or worsening acne. Consistent discomfort or lack of improvement after weeks of use indicates products are unsuitable.


Can Moisturizers Improve Facial Erythema and Support Skin Barrier Function in Phymatous Rosacea?


Yes, moisturizers can improve facial erythema and support skin barrier function in phymatous rosacea. Moisturizers help by maintaining the skin's hydration levels, which is essential in supporting the skin barrier function. The skin barrier is compromised in patients with phymatous, leading to increased irritation, dryness, and sensitivity. Using a moisturizer designed for sensitive skin helps lock in moisture, reducing the potential for irritation and preventing flare-ups that contribute to facial erythema (redness). The hydration helps restore the skin’s natural protective barrier, reducing inflammation and calming the skin.


Moisturizers with soothing ingredients (manuka honey, aloe vera, and hyaluronic acid) assist in reducing facial erythema by calming inflammation and promoting healing. The ingredients have anti-inflammatory properties that help minimize the redness associated with rosacea. Consistent use of moisturizers supports the skin’s ability to repair itself and protect against environmental triggers, which is essential in managing phymatous rosacea effectively.


Is using a moisturizer like EraOrganics Face Moisturizer Cream Helpful in soothing Facial Erythema?

Yes, using a moisturizer like EraOrganics Face Moisturizer Cream is helpful in soothing facial erythema. The EraOrganics Face Moisturizer Cream contains ingredients (manuka honey, aloe vera, and hyaluronic acid), which are known for their relaxing and anti-inflammatory properties. The ingredients help hydrate the skin, restore the skin barrier, and reduce irritation that leads to increased redness. The cream aids in reducing the intensity of facial erythema associated with rosacea by replenishing moisture and providing relief from discomfort. The Face moisturizer cream works to calm the skin, reducing inflammation and promoting skin healing. It helps improve the appearance of the skin, with regular use, minimizing redness and preventing flare-ups.

Can Hypochlorous Acid Spray Reduce Inflammation?


Yes, Hypochlorous Acid Spray can reduce inflammation by mimicking the body’s natural immune response to calm irritated skin. Hypochlorous acid has anti-inflammatory and antimicrobial properties, which help in reducing redness and swelling associated with skin conditions (rosacea). It works by promoting skin healing and soothing irritated areas, making it beneficial for sensitive skin.

Regular use of Hypochlorous Acid Spray improves the skin's natural healing process and the condition of the skin by reducing inflammation and discomfort. The Hypochlorous Acid Spray provides an effective solution for soothing irritated skin and supporting recovery for patients seeking relief from inflammation. The gentle, yet powerful spray helps maintain a balanced and calm complexion.

Nikki Chase

As co-owner Era Organics, Nikki's expertise runs deep. She spends her days immersed in the latest medical studies and scouring trusted websites, ensuring her knowledge reflects the cutting edge of science.

About Nikki Chase

Disclaimer: This content is for informational purposes only and is not intended as medical advice. Always consult with a healthcare professional before starting any new skincare routine or supplement. These statements have not been evaluated by the Food and Drug Administration.

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