ws 2 - dermatology panel...of activated mcs may be a therapy for rosacea treatment. *j invest...

Dermatology

Nat Jones, RPh, FIACPGopesh Patel, RPh

Ranel Larsen, PharmDInternational Seminar

Houston, TXNovember 10‐12, 2016

© 2016. All Rights Reserved. 1

DisclosureNat Jones, RPh, FIACP, and Ranel Larsen, PharmD, are employed by PCCA. Gopesh Patel, RPh, is owner of VLS Pharmacy in Brooklyn, NY and New Drug Loft Pharmacy in New York, NY. Conflict of interest was resolved through peer review of slide content.

Professional Education Services Group staff have no financial interest or relationships to disclose.


DisclosureThis continuing education activity is managed and accredited by Professional Education Services Group. Neither PESG nor any accrediting organization supports or endorses any product or service mentioned in this activity.


Educational Grant Support

This continuing education activity is supported by an educational grant from PCCA.


Learning Objectives• At the conclusion of this activity, the participant will be able to:

– Discuss common triggers of rosacea and active pharmaceutical and cosmetic ingredients used in current treatments of rosacea.

– Discuss ways to offset rising drug prices and to increase prescription fill rates.

– Discuss innovative ingredients and customized solutions for the discerning cosmetic patient.

– Discuss different applications where microneedling can be used and the procedure for using a microneedling device.

– Review different active pharmaceutical ingredients used along with microneedling.


Rosacea

Nat Jones, RPh, FIACP


Histamine• Produced by basophils and

mast cells • Increases capillary

permeability to WBC’s and some proteins, to engage pathogens

• Part of the inflammatory response and a role as a mediator of pruritus


Diamine Oxidase (DAO)• The main enzyme involved in the metabolism of ingested histamine

• DAO supplements are available and can be of plant source, but most are from porcine kidney

• Increased histamine, low DAO availability can lead to urticaria, angioedema, dermatitis, eczema, acne, rosacea, and psoriasis * Acta Med Croatica. 2012 Dec;66(5):375‐81. Lugović‐Mihić L, et al.


Histamine Intolerance

• In patients with symptoms triggered by histamine‐rich food, measuring the serum diamine oxidase activity can help identify subjects who can benefit from a histamine limitation diet and / or diamine oxidase supplementation.

– Int J Immunopathol Pharmacol. 2016 Mar;29(1):105‐11. Serum diamine oxidase activity in patients with histamine intolerance. Manzotti G1, Breda D2, Di Gioacchino M3, BurasteroSE4.


High Histamine Foods

• Alcohol• Pickled or canned foods ‐ sauerkrauts

• Matured cheeses

• Smoked meat products ‐salami, ham, sausages….

• Shellfish• Beans and pulses ‐chickpeas, soy beans, peanuts

* http://www.histamineintolerance.org.uk/about/the‐food‐diary/the‐food‐list/; Maintz L, Novak N: Histamine and histamine intolerance, American Journal of Clinical Nutrition 2007


High Histamine Foods

• Nuts, walnuts, cashew nuts

• Chocolates and other cocoa based products

• Vinegar

• Ready meals• Salty snacks, sweets with preservatives and artificial colorings

* http://www.histamineintolerance.org.uk/about/the‐food‐diary/the‐food‐list/; Maintz L, Novak N: Histamine and histamine intolerance, American Journal of Clinical Nutrition 2007


Mast Cells (MC)


Mast Cells in Rosacea

• Increased numbers in the dermis• Not only recruit other immune cells, which amplifies the inflammatory response, but also cause vasodilation and angiogenesis

• MC proteases have critical functions during the development of inflammation


Mast Cells

• Express extraordinarily high levels of a number of proteases of chymase, tryptase, trypsin‐like serine proteases, and carboxypeptidase A type and these are stored in high amounts as active enzymes in the secretory granules* Blood. 2010 Jun 17;115(24):4981‐90. Mast cell proteases: multifaceted regulators of

inflammatory disease. Pejler G1, Rönnberg E, Waern I, Wernersson S


Kallikrein 5 (KLK5)

• Kallikreins are a subgroup of serine proteases• KLK5 (abnormally high in rosacea skin) cleaves the cathelicidin precursor protein into the bioactive fragment LL‐37 (an antimicrobial peptide), which exerts crucial proinflammatory, angiogenic activities implicated in rosacea, atopic dermatitis, and psoriasis


Cathelicidin LL‐37

• Interestingly, sub‐antimicrobial doses (40 mg/day) of doxycycline, a proven treatment for human rosacea, directly inhibits MMP’s, which in turn inhibits the activity of KLKs and prevents the activation of cathelicidins in human epidermal Keratinocytes. Therefore, Cath LL‐37 has emerged as a key mediator in the pathogenesis of rosacea.


Mast Cell Stabilizers

• We conclude that MCs play a central role in the development of inflammation subsequent to Cath LL‐37 activation and that down regulation of activated MCs may be a therapy for rosacea treatment.* J Invest Dermatol. 2014 Nov;134(11):2728‐36. Mast cells are key mediators of cathelicidin‐

initiated skin inflammation in rosacea. Muto Y1, Wang Z1, Vanderberghe M1, Two A1, Gallo RL1, Di Nardo A1.


Rosacea

• Chronic inflammatory skin disease that affects ≈16 million people in North American

• > 75% of people with rosacea feel the condition has affected their self‐esteem or made them uncomfortable in public settings and avoid social activities (National Rosacea Society)


Rosacea

• Affects both sexes, almost three times more common in women

• Patients often between the ages of 30 to 50 & usually Caucasians


Rosacea

• Characterized by facial redness, small and superficial dilated blood vessels on facial skin, papules, pustules, and swelling


Rosacea

• Primary features – Flushing (transient erythema)

– Non‐transient erythema

– Papules and pustules– Telangiectasia


Erythematotelangectatic Rosacea

• In many cases the skin may be irritated and unusually sensitive

• Telangiectasia– Dilated superficial vessels


Rosacea

• Typically begins as redness on the central face across the cheeks, nose, or forehead, but can also less commonly affect the neck, chest, ears, and scalp


Four Subtypes of Rosacea

• Erythematotelangectatic rosacea: flushing, persistent redness, possible visible blood vessels

• Papulopustular rosacea: persistent redness with bumps and pimples that come and go

• Phymatous rosacea: skin thickening, enlargement of nose from excess tissue

• Ocular rosacea: not covered here


Phymatous Rosacea• It is a myth that rosacea is a disease of alcoholics

Hyperplasia of sebaceous glands


Triggers

• Triggers that cause episodes of flushing and blushing play a part in rosacea development

• Flares can occur without specific triggers, and when left untreated, can take weeks to subside


Most Common Triggers

• Sun exposure 81% • Emotional stress 79% • Hot weather 75% • Wind 57% • Heavy exercise 56% • Alcohol consumption 52% • Hot baths 51%

• Cold weather 46% • Spicy foods 45% • Humidity 44% • Indoor heat 41% • Certain skin‐care products

41% • Heated beverages 36% • Certain cosmetics 27%


Managing Triggers

• One of the most important steps in helping rosacea

• Learn what they are and avoid them if possible– Diary method necessary initially

• Find safe alternatives• Improves the chances of maintaining remission


Triggers

• Medications and topical irritants include:– Microdermabrasion, chemical peels, high dosages of isotretinoin, benzoyl peroxide, and tretinoin

• Steroid‐induced rosacea is caused by the use of topical or nasal steroids


Causes… A Long List of Possibilities• Cathelicidin initiated skin inflammation• Increased levels of the trypsin‐like serine protease,

kallikrein 5• Chlamydia pneumoniae • H. Pylori• Sun exposure, genetic predisposition, topical steroids are

risk factors• Demodex mites


Demodex Mites


Demodex Mites

• Demodex folliculorum live in hair follicles, primarily on the face, as well as in the meibomian glands of the eyelids

• Can produce plugs in hair follicles & sebaceous glands


Demodex Mites

• Demodex brevis live in the sebaceous glands

• Large numbers may play a role along with other triggers in progression


Demodex• Demodex mites have often been found in more than four times greater numbers in rosacea patients

• It is speculated that part of the inflammation is created by bacteria that feed on Demodex feces

– J Med Microbiol. 2012 Nov;61(Pt 11):1504‐10. Potential role of Demodex mites and bacteria in the induction of rosacea. Jarmuda S1, O'Reilly N, Zaba R, Jakubowicz O, Szkaradkiewicz A, Kavanagh K.


Demodex

• Conclusions: Antigenic proteins related to a bacterium (B. oleronius), isolated from a D. folliculorum mite, have the potential to stimulate an inflammatory response in patients with papulopustular rosacea.

– British Journal of Dermatology 2007 DOI 10.1111/j.1365‐2133.2007.08028.x. Mite‐related bacterial antigens stimulate inflammatory cells in rosacea. Lacey N, Delaney S, Kavanagh K, Powell FC


Standard of Care Rosacea Treatment

* Am Fam Physician. 2015 Aug 1;92(3):187‐196. Rosacea: Diagnosis and Treatment. Oge‘ LK, Muncie HL, Phillips‐Savoy AR


Standard of Care Treatment

• Starts with:– Avoidance of triggers – Use of mild cleansing agents – Moisturizing regimens (ceramides)– Photoprotection with wide‐brimmed hats and broad‐spectrum sunscreens (minimum SPF 30)

– Consider green or yellow tinted cosmetics


Central Facial Treatment

• Erythematotelangiectatic without papulopustular lesions– First line:

• Topical: metronidazole, azelaic acid, or brimonidine for erythema

• Vascular laser therapy (pulsed dye laser, intense pulsed light, Nd:YAG laser) for erythema and telangiectasia



• Erythematotelangiectatic with papulopustular lesions, mild to moderate ‐ first line therapy– Topical metronidazole or azelaic acid for erythema– Topical brimonidine adjunctive or in combination with metronidazole or azelaic acid



• Erythematotelangiectatic with papulopustular lesions, mild to moderate ‐ first line cont’d– Topical ivermectin for inflammation; may be used in combination with azelaic acid or metronidazole

– Vascular laser therapy (pulsed dye laser, intense pulsed light, Nd:YAG laser) for telangiectasia


Central Facial Treatment• Erythematotelangiectatic with papulopustular lesions, mild to moderate ‐ second‐line therapy– Alternate topical therapies (sulfacetamide / sulfur, benzoyl peroxide, erythromycin, clindamycin) or subantimicrobial(anti‐inflammatory) dose doxycycline, 40 mg once per day or 20 mg twice per day, alone or in combination with topical agents

Doxycycline 25mg and 50mg capsule formulas exist…


Central Facial Treatment• Erythematotelangiectatic with papulopustular lesions, mild to moderate ‐ third‐line therapy– If limited or no response at 8 to 12 weeks, consider antimicrobial (antibiotic) dose of doxycycline (100 to 200 mg once per day)

– Topical retinoids

• Refractory cases ‐ consider treatment in the moderate to severe category


Central Facial Treatment• Erythematotelangiectatic with papulopustular lesions, moderate to severe ‐ step wise– Topical metronidazole or azelaic acid for inflammation plus subantimicrobial (anti‐inflammatory) dose of doxycycline, 40 mg once per day or 20 mg twice per day

– Topical brimonidine for erythema if needed as adjunctive therapy

– Vascular laser therapy (pulsed dye laser, intense pulsed light, Nd: YAG laser) for telangiectasia



• Erythematotelangiectatic with papulopustular lesions, moderate to severe ‐ step wise cont’d– If limited or no response at 8 to 12 weeks, consider antimicrobial (antibiotic) dose of doxycycline (100 to 200 mg once per day)


Central Facial Treatment• Erythematotelangiectatic with papulopustular lesions, moderate to severe ‐ step wise cont’d– If limited or no response at reassessment, consider alternative oral antibiotic (tetracycline, minocycline metronidazole, azithromycin) and/or topical treatment (sulfacetamide / sulfur, benzoyl peroxide, erythromycin, clindamycin, permethrin)

– If refractory to treatment, consider oral isotretinoin


Standard of Care Treatment• Phymatous ‐mild to moderate (step wise)

– Same as for central facial erythema– Isotretinoin, 0.3 to 1 mg per kg per day for 12 to 28 weeks, microdose therapy for maintenance

– Vascular laser therapy (pulsed dye laser, intense pulsed light, Nd: YAG laser, and carbon dioxide laser), radio therapy

– Dermabrasion, electroscalpel, electrosurgery, loop cautery


Laser Therapy


Pre and Post Laser / Radio Therapy


Medications

• Medications for which evidence of good results exists include ivermectin and azelaic acid creams and brimonidine, doxycycline, and isotretinoin by mouth…lesser evidence supports metronidazole cream and tetracycline by mouth* van Zuuren, EJ; Fedorowicz, Z; Carter, B; van der Linden, MM; Charland, L (28 April 2015).

"Interventions for rosacea.". The Cochrane database of systematic reviews 4: CD003262.


Rosacea• Ivermectin reduces inflammation and kills the Demodex

• The complaint of sensitive skin in rosacea patients often disappears when the number of mites is reduced to normal by treatment** Forton FM. Papulopustular rosacea, skin immunity and Demodex: pityriasis folliculorum as a

missing link. Journal of the European Academy of Dermatology and Venereology 2012;26:19‐28


Compounds for Rosacea• Data regarding the use of topical oxymetazoline to treat the flushing and erythema associated with rosacea are limited, but they suggest improvements in these symptoms with chronic use

• Oxymetazoline HCl 0.06% Topical Cream (formula #11711)* Hosp Pharm. 2013 Jul;48(7):558‐9. Oxymetazoline (topical): rosacea. Generali JA1, Cada DJ2


Compounds for Rosacea

• Brimonidine Tartrate 0.5% Topical Gel (formula #10723)– Apply once daily– Manufactured Gel (Brimonidine 0.33%)* Clin Cosmet Investig Dermatol. 2015 Apr 7;8:159‐77. Update on the management of rosacea.

Weinkle AP, Doktor V, Emer J.


Brimonidine• In the long‐term study (12 months), the most common adverse events included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%)

• Post‐marketing reports suggest that rebound flare of redness and discomfort may be more common than was predicted by clinical trials



• Metronidazole 1% / Niacinamide 4% Topical Cream (formula #11046, #11709, #11883)* Am J Clin Dermatol. 2000 May‐Jun;1(3):191‐9. Topical metronidazole. A review of its use in

rosacea. McClellan KJ1, Noble S.

* Skin Pharmacol Physiol. 2014;27(6):311‐5. Niacinamide ‐mechanisms of action and its topical use in dermatology. Wohlrab J1, Kreft D.


Demodex Treatment Options

• Combined ivermectin / metronidazole therapy was superior in decreasing the D. folliculorumcount to the normal level in rosacea

• Study used oral drugs* Int J Infect Dis. 2013 May;17(5):e343‐7. Evaluation of the efficacy of oral ivermectin in

comparison with ivermectin‐metronidazole combined therapy in the treatment of ocular and skin lesions of Demodex folliculorum. Salem DA1, El‐Shazly A, Nabih N, El‐Bayoumy Y, Saleh S.


If You Can’t Beat Them…

• Ivermectin 1% cream was significantly superior to MTZ 0.75% cream and achieved high patient satisfaction

• Metronidazole 0.75% / Ivermectin 1% Cream (formula #12292) – Apply once daily* Br J Dermatol. 2015 Apr;172(4):1103‐10. Superiority of ivermectin 1% cream over

metronidazole 0∙75% cream in treating inflammatory lesions of rosacea: a randomized, investigator‐blinded trial. Taieb A, et al.



• Milk Thistle 10% / MSM 5% Compound Topical Cream (formula #11936) * J Cosmet Dermatol. 2008 Mar;7(1):8‐14. Combined effects of silymarin and

methylsulfonylmethane in the management of rosacea: clinical and instrumental evaluation. Berardesca E1, Cameli N, Cavallotti C, Levy JL, Piérard GE, de Paoli Ambrosi G.



• Tranilast 1% Topical Cream (formula #11881)– Apply twice daily* clinicaltrials.gov; An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea‐associated

Erythema. Verified August 2013 by University of California, San Diego.



• Ivermectin 1% / Niacinamide 4% Topical Cream (formula #11991) – Apply once daily

• Ivermectin 1% / Niacinamide 5% / Potassium Azelaoyl Diglycinate 15% Cream (formula #12191)– Apply once daily


Vitamin D for Rosacea

• Caution:– Use only if the patients’ level is low, check level before starting, too much can make it worse


Other Vitamins and Supplements That May Cause Exacerbation…

• High doses of: Vitamin A, E, Ascorbic Acid and Niacin• High doses of: CoQ10, Green Tea Extract• Vinpocetine, Gingko Biloba • L‐Arginine & L‐Citrulline ‐ both increase production of high levels of NO and ATP (very strong triggers for rosacea flares as demonstrated in studies by the National Rosacea Society)


Rosacea Gut Connection

• Leaky gut is a possible reason for rosacea genesis and progression

• As inflammation occurs in the gut it can manifest in the skin (detox organ)

• The immune system has two main functions: defense and repair


Rosacea: Treatment Summary1. Fix the diet (eliminate proflammatory & histaminic foods)2. Fix the gut (probiotics, glutamine, etc.)3. Avoid triggers4. Treat the inflammation, put out the fire (1st line: mast cell

stabilizers, 2nd line: sub‐microbial doxycycline)5. Normalize the Demodex count 6. Moisturize7. Use sunscreens


References* J Manag Care Spec Pharm. 2014 Jun;20(6):623‐9. Current drug

therapies for rosacea: a chronic vascular and inflammatory skin disease. Feldman SR, Huang WW, Huynh TT.

* Exp Dermatol. 2014 Dec;23(12):868‐73. Endoplasmic reticulum stress: key promoter of rosacea pathogenesis. Melnik BC1.

* J Invest Dermatol. 2014 Nov;134(11):2728‐36. Mast cells are key mediators of cathelicidin‐initiated skin inflammation in rosacea. Muto Y1, Wang Z1, Vanderberghe M1, Two A1, Gallo RL1, Di Nardo A1.


References* Microb Pathog. 2014 Jun‐Jul;71‐72:37‐40. doi:

10.1016/j.micpath.2014.04.002. Epub 2014 Apr 24. Microbiota of Demodex mites from rosacea patients and controls. Murillo N1, Aubert J2, Raoult D3.

* Cutis. 2007 Feb;79(2):163‐7. The role of Chlamydia pneumoniae in the etiology of acne rosacea: response to the use of oral azithromycin. Fernandez‐Obregon A1, Patton DL.

* J Eur Acad Dermatol Venereol. 2002 Jul;16(4):328‐33. The link between Helicobacter pylori infection and rosacea. Szlachcic A1.


References* J Invest Dermatol. 2014 Nov;134(11):2728‐36.

Mast cells are key mediators of cathelicidin‐initiated skin inflammation in rosacea.Muto Y, Wang Z, Vanderberghe M, Two A, Gallo RL, Di Nardo A.

* Nature Medicine 13, 975 ‐ 980 (2007) Published online: 5 August 2007 |Increased serine protease activity and cathelicidin promotes skin inflammation in rosaceaKenshi Yamasaki, et al.

* The Molecular Pathology of Rosacea: An Expert Interview With Richard L. Gallo, MD, PhDCME Released: 04/23/2010; From Medscape Education Dermatology


References* Song H, Yoo Y, Hwang J, Na YC, Kim HS. Faecalibacterium prausnitzii

subspecies‐level dysbiosis in the human gut microbiome underlying atopic dermatitis. J Allergy Clin Immunol. 2015 Sep 30. pii: S0091‐6749(15)01245‐2

* J Med Microbiol. 2012 Nov;61(Pt 11):1504‐10. Potential role of Demodex mites and bacteria in the induction of rosacea. Jarmuda S1, O'Reilly N, Zaba R, Jakubowicz O, Szkaradkiewicz A, Kavanagh K.

* Clinical and Experimental Dermatology, 2004, 29, 297–299. Remission of rosacea induced by reduction of gut transit time. S. N. Kendall

* Maintz L, Novak N: Histamine and histamine intolerance, American Journal of Clinical Nutrition 2007


Related Documents• Document #99161

– Compounding and Dermatology

• Document #99178– Establish Yourself in the Niche of Dermatology

• Document #99184– Cash‐Friendly Options for– Dermatological Compounding (Part 1)


Dermatology & Cosmeceuticals:The Modern Landscape

Gopesh Patel, RPh


Welcome• Pharmacist since 1980• Owner, VLS Pharmacy & New Drug Loft

Pharmacy in NYC• Our focus:

• Dermatology ‐ clinical & cosmetic• Plastic surgery • Integrative medicine• *New* sterile compounding

• Supporting a network of over 13,000 patients and prescribers a year


Agenda

• Today’s compounding landscape• The opportunity• Clinical dermatology: challenges and solutions• Cosmetic dermatology: challenges and solutions• The new frontier: beyond the skin• Markers for success


The Landscape


Rising Prices and Drug Shortages

• Fact– Brand‐name dermatological prescription prices rose by 401% between 2009 and 2015. Generics rose by 279%.

– The result? Data indicates that 1 in 5 prescriptions go unfilled every year in the USA.


Frustration With One‐Size‐Fits‐All Offers

• Insight– Physicians want to treat patients as individuals and prescribe accordingly.


Aging Population and New Needs

• Facts– Baby boomers account for 74.9 million Americans & anti‐aging marketplace in the USA is estimated to be worth 191.7 billion in 2019


Rise in the Holistic Approach to CareIn their words

“More than ever before, information is more accessible to the general public. This has bred a smarter consumer with regard to all aspects of lifestyle, health, beauty and wellness. This ‘whole food movement’ has trickled down to medicine and patients who are seeking to look and live better and longer…simply looking 20 years younger after surgery is not enough. People want to feel 20 years younger and maintain their results for years to come”.

~ Scott Blyer, MD, FACS


The Opportunities

• Flexibility• Cost effectiveness• Beauty smart• More than skin deep


Clinical Dermatology• What is it?

– The specialty of dermatology that encompasses the complete range of diseases and conditions of the skin, hair and nails. Skin, as the largest organ, covers more than 90 percent of the body. The hair and nails: 10%.

• Most common patient complaints?– Eczema– Psoriasis


Case Study 1

• Problem– Female patient struggles with severe psoriasis for seven years

• Solution– Compound: Zinc pyrithione 0.8% / clobetasol propionate 0.05% / coal tar 5%

Before

After 30 days


Case Study 2

• Problem– Female patient struggled with keratosis pilaris

• Solution– Salicylic Acid 5% / Urea 20% / Ammonium Lactate 2% topical cream

Before After 21 days


Cosmetic Dermatology • What is it?

– Diagnosing, treating, and preventing the changes to the skin that are aesthetically not pleasing to the patient.

• Most popular complaints and concerns?– Hyperpigmentation & melasma– Hair Loss– Skin texture and tone– Wrinkles– Cellulite (good luck!)


Case Study 3

• Problem– Male patient (age 24) struggles with premature, aggressive hair loss

• Solution– Compound: Minoxidil 10% / Finasteride 0.1% / Caffeine Citrate 0.05% / Biotin 0.2%

Before

After 90 days


Case Study 3 (cont’d)


Case Study 4 ‐ Adjunct Care


The New Frontier: Beyond the Surface“While there is not nearly as much data on using IV vs. Topical ingredients for skin improvement, there are well known skin conditions that are difficult to treat topically. IV therapy, as an adjunct to topicals, makes sense when thinking of skin as an organ to be treated from routes of administration. As an example, Vitamin B5 is known as a treatment for both atopic dermatitis and acne, however, the oral dose is 2.2g/day for 2 months to see a benefit. IV B5 gives you the option of getting a higher dose and less often, with quicker onset of action. We see similar examples we look to the easily degradable Vitamin C and other essential vitamins that are commonly used to treat skin.”

~ Erica Walters, MD


The Solution • State‐of‐the‐art USP <797> sterile rooms, one segregated for HD• Exclusively trained and certified technicians • Supporting dermatological and aesthetics needs with 12‐15 different

compounded options• Treating nutritional deficiencies, anti‐aging, and more


Case Study 5 ‐ Nutritional IV Therapy• Opportunity:

– Top dermatology practice opens aesthetic center focused on holistic, therapeutic treatments that treat the skin topically and from the inside out. They are looking for top‐grade IV therapies for anti‐aging and energy.

• Solution:– IV “cocktail” ‐ Vitamin C / Hydroxycobalamin / Folic Acid / B Complex / Calcium Gluconate / Magnesium Chloride


Keys to Success1. Affordable solutions for chronic clinical conditions

– Patients paying cash for compounds can end up paying less than a co‐pay vs. crippling out of pocket prices.

– Generate these without irritating parabens, allergens and in synergistic combinations for the best efficacy, compliance and patient satisfaction.

2. High‐performance anti‐aging and aesthetic adjunct care– Countless cash‐based aesthetic procedures present opportunities

for supplemental care from cost‐effective topical anesthetics to steroids.


Keys to Success (cont’d)

3. Anticipating future needs and awareness of new client trends– The greatest opportunities are the ones that are untapped by the competition. The best way to be ahead is to pay attention and know your client’s business needs inside and out!


Contact Us

[email protected]

[email protected]


References• https://globenewswire.com/news‐

release/2015/05/21/737992/10135534/en/Anti‐aging‐Market‐is‐estimated‐to‐be‐worth‐USD‐191‐7‐Billion‐Globally‐by‐2019‐Transparency‐Market‐Research.html

• http://www.pewresearch.org/fact‐tank/2016/04/25/millennials‐overtake‐baby‐boomers/

• http://www.wsj.com/articles/how‐do‐we‐deal‐with‐rising‐drug‐costs‐1460340357

• www.Netdr.com• https://www.psoriasis.org/about‐psoriasis/treatments/topicals/over‐the‐

counter


Microneedling

Ranel Larsen, PharmD, RPh


Why should you add microneedling to your practice?


Microneedling Benefits ‐ All Areas of the Triad…


• Microneedling is a procedure that uses small, fine needles to create microinjuries in the skin while leaving the epidermis intact* AKA: Percutaneous Collagen Induction or Collagen Induction Therapy


How Does it Work?• Needles break old collagen bundles that tether scars or wrinkles

• This controlled skin injury stimulates the healing cascade and the production of collagen and elastin under the epidermis– Inflammation – Proliferation – Tissue remodeling


Microneedling Increases Collagen Formation

Control biopsy Biopsy from needled skin 6 weeks post‐op; collagen stained purple

* Liebl H, Kloth L. Skin cell proliferation stimulated by microneedles. J Am Coll ClinWound Spec.2012 Dec 25;4(1):2‐6.


Microneedling Significantly Increases Epidermal Thickness

• Enhanced epidermal thickness after one month and three months of microneedling treatments compared to baseline* El‐Domyati M, Barakat M, Medhat W, et al. Microneedling therapy for atrophic acne scars:

an objective evaluation. J Clin Aesthet Dermatol. 2015 Jul;8(7):36‐42.


History of Microneedling


Microneedling is used for many cosmetic conditions, as well as scars and Alopecia.


Devices UsedRoller Pen


Needle Length• 0.5‐3 mm needle length

– Length of needle selected depends on the indication of the treatment

– 0.2 mm ‐ 0.5 mm: Alopecia and at home skin care

– 0.5 mm ‐ 1 mm: wrinkles / skin rejuvenation

– 1.5 mm ‐ 2 mm: scars


Pain increases as the length / depth of the needle increases


Pre‐Procedure Treatment• Use a topical with:

– Vitamin A (retinol)– Vitamin C – Palmitoyl pentapeptide or other peptides

• All of these ensure that collagen production will be maximized and that the skin will heal rapidly

• Use a minimum of 3 weeks before, but preferably 3 months before microneedling


Procedure

1. Clean the skin2. Application of topical anesthetic (not necessary for at‐home device usage) – Can be applied 2 different ways:1. Apply 30‐60 minutes prior to the start of procedure…OR2. Apply after a light “rolling” with the microneedling device


Procedure (cont’d)3. Skin is stretched with one

hand and rolling is done in multiple directions (horizontal, vertical, and diagonal)– Endpoint is identified as uniform pinpoint bleeding * Singh A, Yadav S. Microneedling:

Advances and widening horizons. Indian Dermatol Online J 2016;7:244‐54


Post‐Procedure

• Clean face • Apply serum / topical cream

– Optimal time of skin penetration when using topical products is at 5 minutes as the tissue starts to close considerable after 30 min

– Topical Vitamin A, vitamin C, peptides, hyaluronic acid, etc.


Recovery• Quick recovery due to epidermis remaining intact

• Minimal side effects– Mild redness– Irritation– Inflammation

• Side effects typically dissipate over 24‐48 hours


Counseling Points• Counsel patient to avoid sun exposure and use sunscreen

• Apply serum / cream daily• Repeat treatment usually at one month intervals x 4‐6 treatments

• Takes approximately 3‐6 months for final results


Results ‐ Fine Lines / WrinklesBefore After 1 treatment

* Fernandes, D. Minimally invasive percutaneous collagen induction. Oral Maxillofac SurgClin North Am. 2005 Feb;17(1):51‐63.


Results ‐ Acne Scars / Hyperpigmentation

Before After 3 treatments

* Liebl H, Kloth L. Skin cell proliferation stimulated by microneedles. J Am Coll Clin Wound Spec.2012 Dec 25;4(1):2‐6.


Results ‐ Androgenic Alopecia

Pre treatment ‐ Baseline Post treatment ‐ 12 weeks Weekly microneedling + 1ml

5% minoxidil BID

* Dhurat R, Sukesh MS, Avhad G, et al. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan‐Mar, 5(1): 6‐11.


Contraindications1. Active acne2. Herpes labialis or any other local infection3. Moderate ‐ severe chronic skin conditions (eczema /

psoriasis)4. Patients on anticoagulant therapy 5. Extreme keloidal tendency6. Patients on chemotherapy / radiation


Post Procedure APIsAPI ↓

RednessMoisturizer Anti‐

InflammatoryAids in healing

Anti‐Wrinkle

Simulates collagen

production

Anti‐Oxidant

Beta‐glucan(Up to 2%)

X X X

Hyaluronic Acid(0.5‐2%)

X X X

Niacinamide(Up to 6%)

X X X

Vitamin A(Retinol)(Up to 5%)

X X

Vitamin C(up to 15%)

X X


Obtaining CE

If you would like to receive continuing education credit for this activity, please visit:http://pcca.cds.pesgce.com


Non‐CE Section to Follow


Each Patient Needs . . .

1. Pre‐procedure Rx2. Anesthetic Rx if procedure is office based3. Post treatment / maintenance Rx


Pre‐Procedure Formulations

• PCCA Formula #12349– Retinol 2% / Vitamin C 5% Biopeptide Cream


Topical Numbing Formulations

• PCCA Formula #11652– Benzocaine 20% / Lidocaine 10% / Tetracaine 4% Topical Cream (VersaBase®)

• PCCA Formula #12073– Benzocaine 10% / Lidocaine 5% / Tetracaine 2% Topical Cream (VersaBase®)


Topical Numbing Formulations

• PCCA Formula #9445– Benzocaine 20% / Lidocaine 6% / Tetracaine 4% Topical Lipoderm® (BUD Study)

• VersaBase® is noncomedogenic and is formulated to be nonirritating making it a great choice for this cosmetic procedure


Post Procedure Formulations Base Choice

• PracaSil™‐Plus– Long‐lasting moisturization– Promotes healing and reduces water loss

• Biopeptide Biocosmetic– Contains palmitoyl tripeptide‐3 and palmitoyl pentapeptide‐3 which help build collagen and decrease fine lines and wrinkles


Post Procedure Formulations

• Gels– PCCA Formula #8692

• Sodium Hyaluronate 1%

– PCCA Formula #8693• Sodium Hyaluronate 2% Topical Gel


Post Procedure Formulations• Serums

– PCCA Formula #11841• Niacinamide 5% / Ascorbic Acid 2.5%

– PCCA Formula #12070• Sodium Hyaluronate 0.75% / Ascorbic Acid 5% Topical Serum

– PCCA Formula #12071• Sodium Hyaluronate 0.75% / Ascorbic Acid 10%


Post Procedure Formulations

• Biopeptide– Formula #12072

• Hyaluronic Acid 0.5% / Ascorbic Acid 5% / Beta glucan0.5%

– Formula #12343• Hyaluronic Acid 0.75% / Beta glucan 0.5% / Niacinamide 5% / Retinol 1%


• At home microneedling devices can help increase effectiveness of your formulations– Dispense with cosmetics / Minoxidil / firming formulations

– Counsel patient on appropriate procedure– Counsel patient on cleaning the roller


Androgenic Alopecia Formulations

• PCCA Formula #11104– Minoxidil 5% / Azelaic Acid 5% Topical Foam (VersaBase®)

• PCCA Formula #11353– Minoxidil 10% / Finasteride 0.1% Topical Gel (VersaBase®)


Helpful Materials• Microneedling Apothagram article

– PCCA Document #99244• Proper labeling of cosmetics

– FDA Cosmetic Labeling guide• http://www.fda.gov/downloads • http://www.fda.gov/Cosmetics

– PCCA Document #98678: PracaSil™‐Plus Marketing & Repackaging / Labeling Guidelines


Are you ready to get started?


References* Chiang YZ, Al‐Niaimi F, Madan V. Comparative efficacy and patient

preference of topical anesthetics in dermatological laser treatments and skin microneedling. J Cutan Aesthet Surg. 2015 Jul‐Sep;8(3):143‐6.

* Cohen BE, Elbuluk N. Microneedling in skin of color: a review of uses and efficacy. J Am Acad Dermatol. 2016 Feb;74(2):348‐55.

* Singh A, Yadav S. Microneedling: Advances and widening horizons. Indian Dermatol Online J 2016;7:244‐54


References* El‐Domyati M, Barakat M, Medhat W, et al. Microneedling therapy for

atrophic acne scars: an objective evaluation. J Clin Aesthet Dermatol. 2015 Jul;8(7):36‐42.

* Camirand A, Doucet J. Needle dermabrasion. Aesthetic Plast Surg. 1997 Jan‐Feb;21(1):48‐51.

* Few J, Semersky A. Commentary on: micro‐needling depth penetration, presence of pigment particles, and fluorescein‐stained platelets: clinical usage for aesthetic concerns. Aesthet Surg J. 2016 Aug 16.

* Fernandes, D. Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2005 Feb;17(1):51‐63.


References* Liebl H, Kloth L. Skin cell proliferation stimulated by microneedles. J

Am Coll Clin Wound Spec. 2012 Dec 25;4(1):2‐6. * Dhurat R, Sukesh MS, Avhad G, et al. A randomized evaluator blinded

study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan‐Mar, 5(1): 6‐11.

* Chawla S. Split face comparative study of microneedling with PRP versus microneedling with vitamin C in treating atrophic post acne scars. J Cutan Aesthet Surg. 2014 Oct‐Dec; 7(4): 209‐212.


References* Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet

Surg. 2009; 2: 110‐111. * El‐Fakahany H, Medhat W, Abdallah F, et al. Fractional microneedling: a

novel method for enhancement of topical anesthesia before skin aesthetic procedures. Dermatol Surg. 2016 Jan;42(1):50‐5.

* Gehring W. Nicotinic acid/niacinamide and the skin. Cosmet Dermatol. 2004 Apr;3(2):88‐93.
