The first new prescription acne drugs in almost a decade are on the way for Canadians.
Acne is the most common skin condition in the country. More than 1 million Canadians with acne need medical treatment in order to improve the condition. Acne can cause significant emotional effects and permanent skin scarring.
“The recent completion of pivotal clinical trials for various new acne medications is welcome news for doctors and acne patients,” according to a spokesperson for the Acne and Rosacea Society of Canada.
Quick look – new acne treatments
A new topical (applied to the skin) acne drug, trifarotene, is currently under review by Health Canada for the treatment of moderate acne on the face and body. A Canadian dermatologist and researcher headed up the large scale, worldwide clinical trials on trifarotene.
Meanwhile, in the United States, a New Drug Application (NDA) has just been filed for a new topical drug, clascoterone, the first ever to work by reducing oil production in the skin. A topical that reduces oil production has been called the “Holy Grail” of acne treatment. Clascoterone is for moderate to severe acne.
Also in the US, an NDA is being sought for a new topical formulation of the oral antibiotic minocycline.
For new oral (taken by mouth) acne treatments, a new tetracycline-derived antibiotic, sarecycline, has received FDA approval for moderate to severe acne.
Availability in Canada
“While there are multiple factors involved in whether new drugs are approved by Health Canada, at least some of these will likely be available within the next 12 to 24 months,” a spokesperson for the society added.
- Trifarotene: Currently seeking approval from Health Canada
Trifarotene is a new retinoid, a class of drugs that has been used to treat acne for many years. Retinoids, Vitamin A derivatives, work by increasing the turnover of dead skin cells and exfoliating the skin thereby limiting the development of acne spots.
It is called a “selective” retinoid because it only targets one retinoic acid receptor. This single target action is thought to cause less skin irritation – redness, dryness – than is seen with some existing prescription retinoids that target more receptors.
Trifarotene is also different because it is one of a few drugs that has been clinically tested not only for effectiveness in moderate facial acne but also for moderate body acne on the back and chest. Up to 60% of acne patients have body acne in addition to their facial acne (1).
Results of two Phase 3 clinical trials show after 12 weeks of treatment for moderate facial acne there was a 54.4% and 66.2% reduction in inflammatory acne spots (pimples and red bumps) and a 49.7% and 57.7% reduction in non-inflammatory spots such as blackheads and whiteheads (2).
For moderate body acne on the back and chest, there was a 57.4% and 65.4% reduction in inflammatory acne and a 49.1 and 55.2% reduction in non-inflammatory acne.
- Clascoterone, the first topical that limits oil production in the skin
Clascoterone is the first ever topical (applied to the skin) drug to reduce oil production in the skin – a new mechanism of action for topicals in the treatment of acne. Over production of oil is a major contributor to the development of acne spots.
During puberty, oil glands within the skin stimulated by male hormones known as androgens, enlarge and become overactive, pumping out excess oil. This oily substance combines with dead skin cells to clog skin pores, certain skin bacteria may overgrow, and acne spots develop.
Clascoterone penetrates the skin to reach the androgen receptors in the oil glands. The drug then works to disrupt androgen hormones from the receptors thereby limiting the production of oil. This oil reducing effect in the skin was previously only seen with the use of oral drugs (taken by mouth) such as hormonal pills or isotretinoin.
Results from two Phase 3 clinical trials showed that after 12 weeks of treatment for patients with moderate to severe acne, the reduction in inflammatory lesions (pimples and red bumps) in the 1% clascoterone treatment groups was 44.8% and 47.0% (3). The reduction in non-inflammatory lesions (blackheads and whiteheads) was 30.7% and 29.3%.
Since clascoterone works to block androgens, it is also being investigated using a higher strength of the drug as a treatment for androgenic alopecia, a common form of genetic patterned hair loss in both men and women.
- Minocycline, an oral antibiotic becomes a topical foam to treat acne
Minocycline, an oral antibiotic used to treat acne, has been formulated into a new topical foam for use in moderate to severe acne. Antibiotics work by killing acne bacteria and have anti-inflammatory properties.
This topical antibiotic offers promise in two areas – to lessen antibiotic resistance seen with the use of oral antibiotics and to reduce the risk of significant side effects seen with oral tetracyclines.
The FDA recently accepted an NDA for the medication (4). A Phase 3 clinical trial showed that after 12 weeks of treatment, inflammatory lesions (pustules, papules etc) were reduced by 56% and non-inflammatory spots (blackheads, whiteheads) by 39% (5).
- Sarecycline, a new targeted antibiotic developed to treat moderate to severe acne
Sarecycline, approved by the FDA late last year, is a tetracycline-derived oral antibiotic that was developed specifically to treat acne (6).
It is a targeted antibiotic that has less action against normal bacteria in the gut and elsewhere in the body leading to a lower rate of side effects than is commonly seen with other tetracycline antibiotics. The drug works by killing acne bacteria and reducing inflammation.
Sarecycline is for use in moderate to severe acne. In two Phase 3 trials, at 12 weeks, inflammatory acne on the face was reduced by 51.8% and 49.9% (7). The drug has also been tested on back and chest acne.
Acne Awareness Month September 2019 was designated by the Acne and Rosacea Society of Canada / La Société canadienne de l’acné et de la rosacée to raise awareness about acne, a common skin condition affecting 5 million Canadians that can cause significant physical and emotional effects.
1 Tan JK, Tang J, Fung K, Gupta AK, Thomas DR, et al. Prevalence and severity of facial and truncal acne in a referral cohort. J Drugs Dermatol. 2008;7(6):551-556.
2 Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal ACNE. J Am Acad Dermatol. 2019. DOI: https://doi.org/10.1016/j.jaad.2019.02.044.
3 Cassiopea announces attainment of all primary and secondary endpoints and highly satisfactory safety data in its Phase 3 for Winlevi (Clascoterone) cream in Treating Acne http://www.cassiopea.com/news-and-media/press-releases/yr-2018/181018.aspx Last accessed 15 August, 2019.
4 Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne https://www.globenewswire.com/news-release/2019/03/07/1749738/0/en/Foamix-Announces-FDA-Acceptance-of-New-Drug-Application-for-FMX101-Minocycline-Foam-for-the-Treatment-of-Moderate-to-Severe-Acne.html Last accessed 15 August, 2019.
5 Raoof TJ, Hooper D, Moore A, Zaiac M, et al. Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study. J Am Acad Dermatol. 2019 Jun 1. pii: S0190-9622(19)30882-5. doi: 10.1016/j.jaad.2019.05.078. [Epub ahead of print]
6 Novel Oral Antibiotic Treatment Seysara™ (sarecycline) Now Available https://www.prnewswire.com/news-releases/novel-oral-antibiotic-treatment-seysara-sarecycline-now-available-300779895.html Last accessed 15 August, 2019
7 Moore A, Green LJ, Bruce S, Sadick N, Tschen E, et al. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. J Drugs Dermatol. 2018 Sep 1;17(9):987-996.