The FDA has approved Cabtreo (Bausch Health), a gel containing the retinoid adapalene, the oxidizing agent benzoyl peroxide, and the antibiotic clindamycin, for treatment of acne vulgaris in patients ≥12 years old. Cabtreo is the first three-drug topical formulation to become available in the US for treatment of acne.

Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.

The FDA has approved Twyneo (Galderma), a cream containing the retinoid tretinoin and the oxidizing agent benzoyl peroxide, for once-daily topical treatment of acne in patients ≥9 years old.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

Acne is common among adolescents and young adults, but its prevalence appears to have increased in people of all ages due to prolonged wearing of masks during the COVID-19 pandemic. Guidelines for treatment of acne were last published in 2016.

The FDA has approved trifarotene 0.005% cream (Aklief – Galderma) for topical treatment of acne vulgaris in patients ≥9 years old. Trifarotene is the fourth topical retinoid to be approved in the US for treatment of acne; tretinoin (Retin-A, and others), adapalene (Differin, and generics), and tazarotene (Tazorac, and others) have been available by prescription for decades. Adapalene 0.1% gel has been available over the counter since 2016 for treatment of acne in patients ≥12 years old.

Differin Gel 0.1% (Galderma), a topical formulation of the retinoid adapalene, will soon be available over the counter (OTC) for once-daily treatment of acne in patients ≥12 years old. It is the first topical retinoid to be approved for sale over the counter.

All topical retinoids normalize keratinization and appear to have anti-inflammatory effects; whether any one topical retinoid is more effective than any other is not clear. Many dermatologists now recommend topical retinoids for first-line treatment of acne; they can be used alone or in combination with antibiotics to treat both inflamed and noninflamed acne lesions, or for maintenance treatment. Retinoid/antimicrobial combinations are more effective than either component alone, particularly for patients with inflammatory lesions.1

Adverse effects of topical retinoids include dry skin, scaling, photosensitivity, erythema, burning, and pruritus. Although only small amounts of the drug are absorbed systemically following topical application, adapalene is classified as category C (teratogenic in rats; no adequate studies in pregnant women) for use during pregnancy.

Adapalene (Differin, and generics) is available by prescription in 0.1% gel, cream, and lotion formulations and in a 0.3% gel formulation. It is also available by prescription in combination with the oxidizing agent benzoyl peroxide (Epiduo; Epiduo Forte).

The cost of one 45-gram tube ranges from about $157 for generic adapalene to $580 for Differin.2 The cost of OTC Differin Gel 0.1% was not available at the time of publication.

1. Drugs for acne. Med Lett Drugs Ther 2016; 58:13.
2. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. September 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.

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The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens, and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promotes development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens, and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promote development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.

Veltin Gel (Stiefel), a fixed-dose combination of the antibiotic clindamycin phosphate 1.2% and the retinoid tretinoin 0.025%, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old. Another product containing the same active ingredients (Ziana) has been on the market since 2006.

Epiduo gel (Galderma), a fixed-dose combination of adapalene 0.1% (Differin), a synthetic retinoid analog, and benzoyl peroxide (BPO) 2.5%, an oxidizing agent, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old.

The pathogenesis of acne is multifactorial: follicular hyperkeratinization, bacteria, sebum production, androgens and inflammation all play a role. The gram-positive microaerophilic bacteria Propionibacterium acnes promote development of acne lesions by secreting chemotactic factors that attract leukocytes to the follicle, causing inflammation.