Topical adapalene for acne vulgaris

Case scenario

Lauren, a woman in her mid-20s, asks your advice about treating her skin lesions. She has tried benzoyl peroxide cream for several months, but she is still concerned about her appearance. You note that she has about a dozen visible comedones and several pustules on her forehead. She confirms that she has no other lesions in other areas. She identifies that her skin is quite oily and tells you that she has no other medical conditions, only taking an oral contraceptive.

Learning objectives After reading this article, pharmacists should be able to: Describe the features of acne vulgaris Discuss the role of adapalene in the treatment of acne vulgaris Assess the suitability of supplying adapalene as an over-the-counter treatment for acne vulgaris. Competency Standards addressed (2016): 1.1, 1.3, 1.4, 1.5, 2.2, 3.1, 3.2, 3.3, 3.5

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Introduction

Pharmacists can play an important role in the diagnosis and treatment of acne vulgaris. Non-prescription medicines are commonly used to treat acne, and the recent down-scheduling of adapalene 0.1% to a Pharmacist Only Medicine provides the opportunity for pharmacists to recommend it as an effective treatment for acne vulgaris.

This article provides a review of acne, with a focus on adapalene and its use as a non-prescription medicine to treat acne vulgaris.

Acne vulgaris

Acne vulgaris is a common chronic inflammatory skin condition characterised by the formation of comedones, erythematous papules, pustules, cysts, and nodules on the face, neck, trunk, and shoulders.^1-3

Acne vulgaris is usually benign and self-limiting, but the lesions can cause significant psychological distress and permanent scarring, especially if not treated early and effectively. It is important for pharmacists to be able to identify and manage it effectively, to provide suitable support to patients and to refer in a timely way when its severity warrants expert management.^1-6

Most people will experience acne at some stage in their life, and it affects people of all genders and races.⁷ It is estimated to have a global prevalence of 9.4%.¹ It most commonly begins at puberty andis most frequent in adolescents and young adults.¹ It typically follows a relapsing course over several years, reducing in prevalence as age increases.^1,3

Acne vulgaris is an inflammatory disorder of the pilosebaceous unit, which consists of the hair follicle and its associated sebaceous gland.^1,2,7,8 It is caused by increased sebum production, hyperkeratinisation of the follicle, increased bacterial colonisation with Cutibacterium acnes (formerly Proprionibacterium acnes) around puberty, and inflammation.^1-3,6,8

These changes occur due to increased activity of 5α-reductase and increased androgen receptor sensitivity in the sebaceous gland, especially around puberty. Increased androgen production may also be involved but is a lesser influence.^1,2,5,6

The characteristic lesions of acne vulgaris are caused by blockage of the pilosebaceous canal with a plug of sloughed corneocytes which may be caused by androgen-driven follicular hyperkeratinization, increased sloughing of keratinocytes, enlargement of the sebaceous gland, and an increase in sebum production.^1,2,5,6 Sebum accumulates in the follicle behind the blockage, initially forming a microcomedone which then enlarges to a visible comedone.^1,2,9

Comedogenesis occurs when triglycerides in the accumulated sebum are hydrolyzed into free fatty acids by C. acnes. These fatty acids are cytotoxic and cause inflammation when they are released onto the skin after the follicle opens or breaks down.^1,6,8

Acne vulgaris lesions occur in areas of higher density and activity of sebaceous glands, especially the face and trunk^1,5 and can be classified as non-inflammatory, inflammatory or resolving.⁵

Non-inflammatory lesions are either closed comedones (raised whiteheads with a visible closed plug of sebum) or open comedones (flat blackheads with a visible open plug of sebum with dark oxidised melanin on its surface).^1,4,5,7

Inflammatory lesions occur when the contents of the comedone are released onto the surface of the skin, either by spontaneous opening or rupture by squeezing. The surrounding tissue becomes inflamed leading to the formation of erythematous papules (raised, solid lesions ≤1 cm in diameter), pustules(white or yellow lesions filled with neutrophils and containing pus), cysts (firm lesion containing fluid or semi-fluid material) and nodules (raised, solid lesions >1 cm in diameter that reach into deeper layers of the skin).^1,4,5,7

Resolving lesions comprise macules (patches of skin that are altered in colour but are usually not raised) and scars that form after other acne lesions have resolved.^1,5

Acne vulgaris is mainly diagnosed by its typical presentation and characteristic type and distribution of lesions. Measurement of blood levels of hormones may be required if the presentation is atypical.¹ See Table 1.

Acne can occur outside the typical ages of adolescence or early adulthood. Awareness of these presentations is important in differential diagnosis.^1,4

Many other infectious or inflammatory skin conditions share some of the characteristics of acne vulgaris; however, the separate distinctive features of each usually provides a means of differential diagnosis. Pharmacists should refer the patient to an expert if there is any doubt about the diagnosis.⁴

Skin may become hyperpigmented, or less commonly hypopigmented, after inflammatory lesions have resolved. The risk of this is higher with more severe disease and in people with darker skin.^1,3,10,11

Table 1 – Atypical presentations of acne by age

NAME	TYPICAL AGE OF ONSET	FEATURES	LIKELY CAUSE	COMMENT
Neonatal acne	First 6 weeks of life	Papules and pustules on the face	Maternal and neonatal androgens and colonisation of sebaceous glands by Malassezia species	Resolves spontaneously
Infantile acne	Up to 12 months of age	Open and closed comedones, inflammatory papules, pustules, nodules and cysts, especially on the cheeks	Increasing sensitivity to androgens	Usually resolves within 12 months of onset
Mid-childhood acne	Ages 1–6/7	Comedones, inflammatory papules and pustules on the face	Rare, and may be a sign of an underlying hyperandrogenisation disorder	Requires further investigation
Preadolescent acne	Ages 6/7–11	Comedones on the forehead may progress to inflammatory papules and pustules on the centre of the face	Usually considered normal, as a sign of early adrenarche	May be a sign of an underlying androgen disorder that requires further investigation
Acne tarda (adult acne)	Adults in their 30s and 40s, most commonly in women	Inflamed papules and pustules with relatively few comedones, more commonly on the jawline and neck	New, persisting or relapsing acne vulgaris	Often flares before menstruation
Drug-induced acne	Sudden onset upon exposure to the causative agent	Inflammatory papules or pustules with few comedones, distributed beyond the usual sebaceous gland areas	Common medicines involved include corticosteroids, anabolic steroids, testosterone, isoniazid, lithium, halogens, EGFR inhibitors, TNF antagonists and capecitabine	Resolves when causative agent is removed
Acne excoriée	Any age	Exacerbation of existing comedones  and inflammatory papules	A result of picking and scratching of acne lesions

Scarring may occur at the site of lesions, especially nodulocystic or fulminans variants; however, comedones can also scar. Early, effective treatment minimises the risk of scarring and the associated psychological distress it can cause.^1,2 This is a key treatment goal as treatment of residual scars can be difficult and have limited success.¹

Adult acne, beyond the age of 25, is the most common dermatological condition amongst non-Caucasians, with post-inflammatory hyperpigmentation (PIH) being the most concerning aspect reported by this group.^9,11

The general pathology and treatment of acne vulgaris in skin of colour is the same as for lighter skin; however, individuals with darker skin types (Fitzpatrick skin type IV–VI) present more frequently with PIH and keloidal or hypertrophic scarring than do people with lighter skin.^9-11

Acne vulgaris is commonly graded by severity to guide treatment. Pharmacists should understand the concept of severity grading to allow them to recommend appropriate treatment or referral. The counting of lesions can be imprecise, and these grades should be considered a general guide.^1,4,5,7

Mild

• Few comedones (<20) and inflammatory lesions (<15), or total lesion count less than 30.
• No scarring.
• Lesions are often confined to the forehead, nose and chin.

Moderate

• Numerous comedones (20–100) and inflammatory lesions (15–50), or total lesion count 30–125.
• Some nodules but no scarring.
• Lesions affect extensive areas of the face and sometimes the trunk.

Severe

• Total comedone count more than 100 and total inflammatory count more than 50, or total lesion count more than 125.
• More than 5 pseudocysts.
• Nodules, cysts and scarring may be confined to the face but also commonly affect the trunk.
• Acne conglobata is a rare form of nodulocsystic acne involving severe, destructive and highly inflammatory acne, with groups of joined comedones, nodulocystic lesions and deep interconnected abscesses which become secondarily infected. It can appear on the trunk, limbs and buttocks.
• Acne fulminans occurs most commonly in young males (13–16 years old), and involves a sudden onset of painful haemmorhagic pustules and ulcerating nodules, along with a wide range of systemic inflammatory symptoms. Comedones are uncommon.

Treatment of acne vulgaris

Acne vulgaris treatment is focused on reducing the severity and improving the appearance of lesions, and minimising scarring, and adverse psychological effects.^1,5,7 A focus on early effective treatment in the acute inflammatory phase can reduce the risk of sequelae in all grades and for all skin types.^6,9,10,12

Specifically, this can be achieved by^1,3,12:

• Preventing follicular hyperkeratosis
• Reducing C. acnes population
• Inhibiting sebum secretion and fatty acid production
• Eliminating comedones.

Topical medicines are recommended in the treatment regimens for all grades of acne vulgaris, either alone or in combination with systemic medicines.^1,5,7 The current Australian treatment guidelines for acne vulgaris include,amongst other medicines, topical benzoyl peroxide (BPO) and adapalene, either alone or in combination. The availability of these as non-prescription medicines allows pharmacists to recommend effective treatments early, especially in mild disease.^4,5 Topical retinoids, with or without BPO, are considered the treatment of choice for mild to moderate acne vulgaris and can be used in both initial and maintenance stages of treatment, as well as after oral treatment of severe acne vulgaris.^1-3,5

Topical or oral antibiotics, oral retinoids, or oral anti-androgens (for females) may be added to the topical treatment regimen for moderate and severe acne vulgaris, depending on severity and the response to topical treatments.^1,5

Azelaic acid is also available as a non-prescription medicine and is indicated for treatment of acne¹³; however, it is probably less effective than BPO14 and is not included in Australian treatment guidelines.⁵ The relative efficacy and adverse effect profile of azelaic acid and adapalene is uncertain.¹⁴

Pharmacists can use their knowledge of acne vulgaris to advise patients and to refer if appropriate. This is especially important when deciding if a non-prescription medicine is suitable.^1,2,4 Patients should be referred to a medical professional if acne has an atypical presentation, is severe (cystic, nodular orvery inflammatory), or is causing scarring or significant psychological distress.⁵

Most patients discontinue topical treatment because of actual or perceived lack of effectiveness, with one study showing the median overall duration of treatment to be 2 months.This contrasts with the chronic nature of acne vulgaris and the known slow response to treatment.^5,15,16

Pharmacists should encourage adherence to treatment by helping patients identify suitable treatment regimens, explaining the likely timeframe for improvement, and advising how to manage adverse effects.⁴

Adapalene

Topical retinoids bind to retinoid receptors, inhibiting keratinocyte proliferation. This reduces follicle obstruction and prevents the formation of microcomedones.^1,3,8,17,18 They have anti-inflammatory, comedolytic, keratolytic and immunomodulatory effects^1-3,8,17 and are considered the first-line topical therapy for initial and maintenance treatment of comedonal and inflammatory acne vulgaris.^3,10,18,19 They are considered safe and effective1 and can be used indefinitely.¹⁹

Topical retinoids can also improve skin tone and the appearance of pigmented lesions by facilitating melanosome transfer and facilitating melanin dispersion and removal. This is especially useful in treating PIH in skin of colour.^1,7,10,11 They may also reduce existing scarring and reduce the risk of subsequent scarring.^1,7

Adapalene is a third-generation retinoid, developed to reduce the adverse effects of the earlier generations of retinoids by increasing specificity for the beta and gamma isoforms of the retinoic acid receptor, found in dermal fibroblasts and the epidermis respectively.¹⁷ It is absorbed to a relatively low extent in the corneum, increasing its concentration in the epidermis and hair follicle, which are therapeutic targets in acne.¹⁷

Adapalene is considered to have the best tolerability and least irritation among topical retinoids^1.8; however, the actual difference between them appears minor.¹ Adapalene 0.1% gel and cream is indicated for the “topical treatment for comedo, papular and pustular acne vulgaris of the face, chest or back”,²⁰ and adapalene 0.1% gel combined with benzoyl peroxide 2.5% is indicated for “cutaneous treatment of acne vulgaris on the face, chest and back when comedones, papules and pustules are present, and the condition has not responded to first line treatment”.²⁰

In October 2021 adapalene was rescheduled as a Pharmacist Only medicine In Australia, for supply by a pharmacist ‘in topical preparations containing 0.1 per cent or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age’.^22,25 This listing also allows the supply of combination products, including with BPO, but does not include adapalene 0.3% products which remain prescription-only, nor its use for cosmetic purposes.^4,22,25

Pharmacist-only supply to children under 12 years old is not permitted as the safety and efficacy of adapalene has not been demonstrated in that age group.²²

This down-scheduling provides a new non-prescription medicine for patients to access an effective treatment more readily for acne vulgaris and requires pharmacists to carefully consider the suitability and safety of adapalene for each individual patient.⁴

Combination with benzoyl peroxide

Adapalene 0.1% in combination with BPO 2.5% (Epiduo) is more effective than either component alone^3,8,13 but has a higher discontinuation rate from adverse effects such as irritation and burning than single-component treatments.^1,12,13,32 BPO is bactericidal to C.acnes, thereby reducing sebum lipolysis and the production of inflammatory products, and it also has keratolytic and comedolytic effects.^1,6,7

Australian treatment guidelines for mild acne vulgaris recommend using a topical retinoid alone initially, then if response is inadequate, using a combination of adapalene 0.1% and BPO 2.5% for mainly comedonal acne, and a combination of BPO 2.5% and clindamycin 1% for acne with inflammatory lesions.⁵ Other sources however recommend a combination of adapalene 0.1% and BPO 2.5% as the first line treatment for both comedonal and inflammatory presentations.^1,2,12

Adverse effects

Topical retinoids commonly cause adverse skin effects or exacerbation of acne, especially in the first few weeks of treatment, after which they typically subside.^1,3,5,10,15 These adverse effects include local skin dryness, flaking, peeling, erythema, thinning of the stratum corneum, burning sensation, and irritation.^{1-3,7,26,27,30,31} Slow introduction of topical retinoids may reduce the risk of adverse effects.^3,10 Asian skin is reported to be more sensitive to these adverse effects.¹

Pregnancy

Retinoids as a class are known teratogens, which is the main safety consideration for their use.^22,26-28 Adapalene is classified in pregnancy Category D, with the Product Information citing evidence of teratogenicity in animal studies (albeit at very high exposures compared to expected human clinical exposure), noting that there are no suitable studies involving pregnant women, and that there have been isolated reports of birth defects in babies born to women using adapalene. Consequently, adapalene is not recommended for use in pregnancy or by women intending to become pregnant and treatment should be stopped if pregnancy occurs.^26-28

There are no studies about adapalene excretion in breast milk; however, due to its low systemic absorption and low maternal blood levels with long-term use, it probably has a low risk of causing harm. This can be minimised by avoiding use on areas where an infant might suckle.^27,27,29

Use and counselling

Pharmacists should refer to the Product Information and Consumer Medicine Information for full details about the proper use and counselling of adapalene products.^26,27,30,31

Adapalene-containing products:

• should be applied once daily, usually at night, to minimise medicine photodegradation and skin photosensitivity.^1,30,31 Morning washing of the face to remove the product helps reduce photosensitivity.^3,5,10,15
• should be applied to all acne-affected areas, not just single lesions, to reduce microcomedones formation.^3,5,10,15
• can irritate the skin initially, which can be reduced by applying every second night for the first 2 weeks, then nightly thereafter.^3,5,10,15 Effective moisturising increases tolerance to irritation and improves treatment adherence.^10,19
• work slowly and can take several months to show improvement.^1,5
• in cream bases should be used for dry skin, and in gels bases for oily skin.¹

Good general skin care can improve skin health and help reduce severity of acne and the risk of scar formation. Specifically, patients should be advised to use low-irritant, pH-balanced, soap-free cleansers instead of harsh or drying soaps, use non-comedogenic skin care and cosmetic products, pat skin dry after washing rather than scrubbing exfoliating and avoid picking or squeezing acne lesions.^1,5,7,10

The scheduling of adapalene as a Pharmacist Only medicine recognises pharmacists’ qualifications to manage potential risks associated with teratogenicity.²² Part of meeting this requirement, as adapalene can be supplied by pharmacists to children over 12 years, the possibility exists of becoming aware of child sexual abuse. Pharmacists must manage this part of counselling with sensitivity to patient age and reproductive status, and attention to privacy, especially when carers are involved.⁴ Pharmacists can take guidance and further information from professional guidelines such as PSA’s Emergency Contraception guidelines,³³ or from the Australian Institute of Family studies which publishes useful information about sexual consent and consent laws across Australia.^34,35

Case scenario continued

Lauren’s acne appears to be mild, and you recommend that she ceases BPO and start applying adapalene 0.1% gel every second day at bedtime, to minimise initial irritation, increasing to daily application after about 2 weeks if tolerated. You explain that she should gently wash and dry her skin before application and apply the gel to her entire forehead to treat microcomedones, and that she can remove any residual gel by washing in the morning to minimise photosensitivity during the day. She already has a suitable non-comedogenic skincare regimen, which you encourage her to continue with special emphasis on moisturising to reduce possible adverse effects of adapalene, explaining that it may be several months before the full beneficial effects are seen. You explain the risk of teratogenicity to her and reinforce the importance of effective contraception.

Key points

• Acne vulgaris is a common skin disorder, characterised by comedonal and inflammatory lesions which can cause permanent scarring and pigmentation changes.
• Early effective treatment improves the appearance of acne vulgaris, reduces the risk of permanent skin damage, and can reduce the associated psychological harm.
• Topical retinoids have anti-inflammatory, comedolytic, keratolytic and immunomodulatory effects, and are the core of treatment for acne vulgaris.
• Adapalene 0.1% has recently been approved for pharmacist-only supply, providing a new pathway for patients to access it readily as a safe and effective topical treatment for acne vulgaris.

References

1. Leung A, Barankin B, Lam J, et al. Dermatology: how to manage acne vulgaris. Drugs Context 2021;10:1–18.
2. Oge L, Broussard A, Marshall M. Acne vulgaris: diagnosis and treatment. Am Fam Physician 2019;100(8):475–84
3. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther (Heidelb) 2017;7:293–304.
4. Sansom LN, ed. Acne. Australian pharmaceutical formulary and handbook online. 2021. At: https://apf.psa.org.au/non-prescription-medicine-guides/acne/acne 
5. Acne. 2021. In Therapeutic Guidelines. Melbourne. Therapeutic Guidelines Ltd. At: https://tgldcdp.tg.org.au/viewTopic?topicfile=acne&guidelineName=Dermatology&topicNavigation=navigateTopic 
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11. Lawson C, Hollinger J, Sethi S, et al. Updates in the understanding and treatments of skin & hair disorders in women of color. Int J Womens Dermatol 2017;3:S21–S37.
12. Stuart B, Maund E, Wilcox C, et al. Topical preparations for the treatment of mild-to-moderate acne vulgaris: systematic review and network meta-analysis. Br J Dermatol 2021;185:476–7.
13. Rossi S, ed. Australian medicines handbook online. Adelaide: Australian Medicines Handbook; 2021. At: https://amhonline.amh.net.au/ 
14. Liu H, Yu H, Xia J, et al. Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne. Cochrane Database of Systematic Reviews 2020, Issue 5.
15. Hoai X, De Maertelaer V, Simonart T. Real-world adherence to topical therapies in patients with moderate acne. JAAD Int 2021;2:109–15.
16. Tuchayi S, Alexander T, Nadkarni A, et al. Interventions to increase adherence to acne treatment. Patient Prefer Adherence 2016;10:2091–6.
17. Rusu A, Tanase C, Pascu G, et al. Recent advances regarding the therapeutic potential of adapalene. Pharmaceuticals 2020;13:217–39.
18. Zanglein A, Pathy A, Schlosser B, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2016;74:945–73.
19. Santer M, ed. Stemming the tide of antimicrobial resistance: implications for management of acne vulgaris. Br J Gen Pract 2018;68(667):64–5.
20. Australian Government Department of Health Therapeutic Goods Administration. 1998. DIFFERIN. Public summary for ARTG entry. https://tga-search.clients.funnelback.com/s/search.html?query=adapalene&collection=tga-artg 
21. Australian Government Department of Health Therapeutic Goods Administration. 2009. EPIDUO. Public summary for ARTG entry. https://tga-search.clients.funnelback.com/s/search.html?query=adapalene&collection=tga-artg
22. Australian Government Department of Health Therapeutic Goods Administration. Notice of interim decisions on proposed amendments to the Poisons Standard – ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020. At www.tga.gov.au/book-page/14-adapalene 
23. Piskin S, Uzunali E. A review of the use of adapalene for the treatment of acne vulgaris. Ther Clin Risk Manag 2007;3(4)621–4.
24. Gauld N. New Zealand first to have OTC topical adapalene available in pharmacies. The Pharmaceutical Journal. 2016. At: https://pharmaceutical-journal.com/article/letters/new-zealand-first-to-have-otc-topical-adapalene-available-in-pharmacies 
25. Australian Government Department of Health. SUSMP No. 34 (Poisons Standard October 2021). At: www.legislation.gov.au/Series/F2021L01345 
26. Galderma Australia. 2020. Differin (Adapalene) Topical Cream and Gel. Australian Product Information. At www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=adapalene
27. Galderma Australia. 2019. Epiduo Gel. Australian Product Information. At: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=adapalene 
28. Australian Government Department of Health Therapeutic Goods Administration. Prescribing medicines in pregnancy database. 2020. At: www.tga.gov.au/prescribing-medicines-pregnancy-database 
29. Adapalene. In: Drugs and Lactation Database (LactMed). 2018. At: www.ncbi.nlm.nih.gov/books/NBK501423/ 
30. Galderma Australia. 2020. Differin Gel and Cream. Consumer Medicine Information. At www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=adapalene 
31. Galderma Australia. 2019. Epiduo Gel. Consumer Medicine Information. At: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=adapalene 
32. Yang Z, Zhang Y, Lazic Mosler E et al. Topical benzoyl peroxide for acne. Cochrane Database of Systematic Reviews 2020, Issue 3.
33. Sansom LN, ed. Guidance for provision of a Pharmacist Only medicine – Emergency Contraception. Australian pharmaceutical formulary and handbook online. 2021. At: https://apf.psa.org.au/non-prescription-medicine-guides/guidance-provision-pharmacist-only-medicine%E2%80%94emergency-contraception 
34. Australian Institute of Family Studies. Age of consent laws in Australia. 2021. At: https://aifs.gov.au/cfca/publications/age-consent-laws
35. Australian Institute of Family Studies. Mandatory reporting of child abuse and neglect. 2020. At: https://aifs.gov.au/cfca/publications/mandatory-reporting-child-abuse-and-neglect

BEN GILBERT MPS B Pharm, Grad Cert Higher Education, Grad Dip Applied Science (Toxicology) has experience as a community pharmacist, pharmacy owner, medication review accredited pharmacist and university lecturer and researcher. He has worked with developing countries in the Pacific region to strengthen their medical supply chain workforce and systems.