Acne in Primary Care

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Acne in Primary Care

The treatment of acne involves difficult choices. Should you prescribe oral antibiotics, knowing use of the drugs for acne plays a large role in driving up rates of antibiotic resistance? Are you willing to wade through the complex federal laws regulating isotretinoin before prescribing it to people who can become pregnant? And why do so many patients complain topical retinoids make them feel like their face is peeling off?

But perhaps the biggest challenge in treating acne is lack of compliance: One study found half of patients prescribed a topical therapy had given up on the regimen within 3 months, either because they felt it wasn’t working or they could not tolerate the side effects.

Things have changed.

The US Food and Drug Administration has approved several new medications in the last 6 years that address these shortcomings and require only one dose per day, potentially enhancing patient compliance and, as a result, improving outcomes.


Overview of New Medications

Here is the basic approach to acne care, as outlined in 2016 guidelines from the American Academy of Dermatology (AAD):

Topical treatment (eg, benzoyl peroxide [BPO], antibiotics, and retinoids) is generally used as first-line treatment in cases of mild-to-moderate acne with comedonal and inflammatory lesions.


Systemic treatment (eg, oral antibiotics and hormonal therapy) can be used as first-line treatment in cases of moderate to severe acne, in combination with a topical agent.

Dermatologists today rarely use oral clindamycin and erythromycin for acne since antibiotic resistance has severely limited the effectiveness of these drugs. That leaves the tetracycline class as the antibiotic of choice, since it also has a strong anti-inflammatory effect. But tetracyclines can disrupt the gut microbiome, and minocycline in particular may cause rare but serious complications like irreversible hyperpigmentation and hypersensitivity reactions. Although much of the drive to reformulate older topical medications is to allow manufacturers to maintain their patents on the products, research into ways to make a cream or lotion easier on the skin is another important avenue of research. “The vehicles do really matter,” said Arash Mostaghimi, MD, MPH, an associate professor of dermatology at Harvard Medical School in Boston. “A lot of the innovation in this space is actually in the delivery.”

The payoffs from this line of research include two new versions of older topical agents, tretinoin and tazarotene, which the FDA approved in 2018 and 2019, respectively. The novel technology for these two agents, as Baldwin explained, allows the active ingredient to deposit on the skin in a honeycomb-like mesh that also contains a protective moisturizer. “It has taken a virtually intolerable drug like tazarotene and made it into one of the mildest formulations of topical retinoids that we have,” Baldwin said.


Trifarotene, initially developed for psoriasis, is another topical retinoid worthy of mention. Retinoids are vitamin A derivatives that bind different retinoic acid receptors (RARs); trifarotene is known as a next generation retinoid, because it is the first to selectively bind to RAR-gamma, the most common RAR in the skin. This affinity allows the drug to be effective at low concentrations, reducing systemic absorption and side effects. Studies have shown trifarotene is safe to use over large areas of the skin, so many dermatologists recommend it for people with acne extending to the shoulders and back.

The newest combination drug on the market, approved in October, is the first fixed-dose triple-combination topical treatment for acne. Containing clindamycin, BPO, and adapalene, a retinoid, the product should be available to consumers in 2024. “The amazing thing about the data is that it really looks as though the combination of all three have a synergistic effect. It is not just better — it’s dramatically better,” Baldwin said.

The treatment of acne involves difficult choices. Should you prescribe oral antibiotics, knowing use of the drugs for acne plays a large role in driving up rates of antibiotic resistance? Are you willing to wade through the complex federal laws regulating isotretinoin before prescribing it to people who can become pregnant? And why do so many patients complain topical retinoids make them feel like their face is peeling off?

But perhaps the biggest challenge in treating acne is lack of compliance: One study found half of patients prescribed a topical therapy had given up on the regimen within 3 months, either because they felt it wasn’t working or they could not tolerate the side effects.

That’s why Hilary Baldwin, MD, a dermatologist and director of the Acne Treatment & Research Center in Brooklyn, New York, welcomed the FDA approval in 2019 of topical minocycline. Far less of the topical formulation is absorbed by the body compared to a 3-week course of oral medication, Baldwin said.

“The concentration in the skin is extraordinarily high, while the concentration in the body is extraordinarily low, which is just the kind of combination we want,” she said. And the drug is effective for inflammatory lesions that previously would have required oral treatment with antibiotics or hormonal therapy.

Baldwin also frequently prescribes sarecycline, a narrow-spectrum tetracycline that has been available since 2018.

“It has all of the nice qualities of tetracycline in terms of its efficacy in treating acne, but it is probably less likely to do damage in the gut and hit off-target organisms,” she said. Another benefit is once-a-day dosing. Although sarecycline hasn’t undergone head-to-head trials with other tetracyclines, Baldwin said she has seen fewer side effects from the drug in her patients.Dr Arash Mostaghimi

Although much of the drive to reformulate older topical medications is to allow manufacturers to maintain their patents on the products, research into ways to make a cream or lotion easier on the skin is another important avenue of research. “The vehicles do really matter,” said Arash Mostaghimi, MD, MPH, an associate professor of dermatology at Harvard Medical School in Boston. “A lot of the innovation in this space is actually in the delivery.”

The payoffs from this line of research include two new versions of older topical agents, tretinoin and tazarotene, which the FDA approved in 2018 and 2019, respectively. The novel technology for these two agents, as Baldwin explained, allows the active ingredient to deposit on the skin in a honeycomb-like mesh that also contains a protective moisturizer. “It has taken a virtually intolerable drug like tazarotene and made it into one of the mildest formulations of topical retinoids that we have,” Baldwin said.

The next trick is to use these technologies to create combination products. Although often prescribed together, topical retinoids and BPO creams cannot be applied at the same time because BPO oxidizes the retinoid, reducing its activity. Both drugs also cause significant skin irritation.

A technology called microencapsulation gets around these obstacles. A silica shell traps the active ingredients, which prevents them from interacting with each other while allowing their slow release. Microencapsulated drugs can be packaged in the same bottle and used at the same time, so that patients do not need to apply one medication in the morning and the other at night.

Trifarotene, initially developed for psoriasis, is another topical retinoid worthy of mention. Retinoids are vitamin A derivatives that bind different retinoic acid receptors (RARs); trifarotene is known as a next generation retinoid, because it is the first to selectively bind to RAR-gamma, the most common RAR in the skin. This affinity allows the drug to be effective at low concentrations, reducing systemic absorption and side effects. Studies have shown trifarotene is safe to use over large areas of the skin, so many dermatologists recommend it for people with acne extending to the shoulders and back.

The newest combination drug on the market, approved in October, is the first fixed-dose triple-combination topical treatment for acne. Containing clindamycin, BPO, and adapalene, a retinoid, the product should be available to consumers in 2024. “The amazing thing about the data is that it really looks as though the combination of all three have a synergistic effect. It is not just better — it’s dramatically better,” Baldwin said.

Mostaghimi said he also has been impressed with the data, and predicted providing triple treatment in a non-irritating fashion once daily would dramatically increase adherence.

Topical clascoterone, approved in the United States in 2020, is the first acne drug with a novel mechanism of action to reach the market in 40 years. Clascoterone addresses hormonal acne, which is related to elevated androgen levels. The condition is most common in adult women, particularly during menses, but also affects men.

Androgens bind androgen receptors present in the skin and stimulate the production of sebum. Although its precise mechanism of action is not well understood, clascoterone inhibits binding to androgen receptors, and may work by disrupting sebum production. The drug also inhibits pro-inflammatory cytokines and inflammatory follicular activity.

A study published earlier this year in JAMA Dermatology found prescriptions for spironolactone for women with acne rose nearly fourfold between 2017 and 2020, nearly matching orders for oral antibiotics by the end of that period.

However, spironolactone cannot be safely used in men, nor in women who are pregnant or breastfeeding. Clascoterone provides a safe and effective topical option for men and women and works for both comedonal lesions and inflammatory acne.

“If you’re dealing with someone who has primarily comedonal acne, the newer tretinoin lotion, the newer tazarotene lotion, and the new trifarotene cream are your best bets,” Baldwin said. She added that the average successfully treated acne patient requires two to three medications, making the fixed combination medications a logical next step. “I think that [triple therapy] will make a huge difference,” she said.

Lastly, clascoterone offers a good alternative to oral isotretinoin for treatment of hormonal acne. According to Baumann, “If you have a cystic acne person, it’s hard to get that under control with just topicals.” But for patients with hormonal acne, she recommended a trial of topical clascoterone first, with oral contraceptives as another option for women.

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