SC1401 and at weeks 9 (29.9% vs 22.1%, respectively; P=0.019) and 12 (33.2% vs 25.7%, respectively; P=0.024) for SC1402 (Figure 3A-B). IGA success rate was significantly greater in the sarecycline group than in the placebo group at weeks 3 (12.13% vs. 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001) for back acne (Table 3; Figure 3C).
Pooled Safety
The safety data of these studies have previously been reported.14 In brief, sarecycline was well tolerated with no serious AEs related or possibly related to study treatment and no deaths were reported.14
DISCUSSION
To date, there is a conspicuous absence of scientific data based on well-designed and controlled studies when it comes to the management of truncal acne. Current systemic treatment options are based on recommendations for facial acne, and very little is known about truncal acne regarding the effectiveness and optimal use of various treatment options.1,2,9 In addition, using clinical studies on facial acne to provide recommendations for truncal acne can be problematic. For example, available data suggest that using benzoyl peroxide as a cleanser/wash or in low-to-moderate concentrations as a short-contact therapy are not effective in reducing C. acnes on the trunk, unlike results associated with BP use on the face.15
With the exception of trifarotene cream, most clinical trials evaluate the use of topical therapies for truncal acne and are small in size.9,16,17,18 Dapsone 7.5% gel was evaluated in a 16-week, open-label pilot study and improved IGA and lesion counts in moderate to severe truncal acne.16 In addition, azelaic acid 15% foam has been effective in improving IGA and lesion counts on the trunk in a 16-week, open-label pilot study in moderate truncal acne.17 Topical trifarotene cream applied once daily was evaluated in 12-week phase 3 studies for both facial and truncal acne and is FDA-approved for acne treatment.18 Topical trifarotene significantly reduced Physician Global Assessment (PGA) scores reduced both inflammatory and noninflammatory lesions in truncal acne.18 Importantly, unlike facial acne, truncal acne often affects a large body surface area, which can create difficulty with applying a topical treatment consistently in some patients; oral therapy is often utilized for management of truncal acne due to ease of use and the perception of clinicians that oral therapy is often needed to obtain efficacy, especially for moderate-to-severe acne.1,9,19 Thus, oral antibiotics, isotretinoin, or spironolactone with or without COCs (in women) remain preferred treatment options, with treatment selection based on patient-specific factors; with an oral antibiotic such as sarecycline, or with spironolactone, combination treatment with topical therapy is often a rational approach.2,9
Current broad-spectrum oral antibiotics prescribed for moderate to severe acne may be limited by side effects and bacterial resistance to antibiotics.3,4 By contrast, narrow-spectrum antibiotics, including sarecycline, exhibit less antibiotic selection pressure and have shown a low propensity to induce bacterial resistance.10 While further studies are needed to further confirm the minimal impact of sarecycline on the microbiome, the use of broad-spectrum tetracycline-class drugs such as doxycycline
With the exception of trifarotene cream, most clinical trials evaluate the use of topical therapies for truncal acne and are small in size.9,16,17,18 Dapsone 7.5% gel was evaluated in a 16-week, open-label pilot study and improved IGA and lesion counts in moderate to severe truncal acne.16 In addition, azelaic acid 15% foam has been effective in improving IGA and lesion counts on the trunk in a 16-week, open-label pilot study in moderate truncal acne.17 Topical trifarotene cream applied once daily was evaluated in 12-week phase 3 studies for both facial and truncal acne and is FDA-approved for acne treatment.18 Topical trifarotene significantly reduced Physician Global Assessment (PGA) scores reduced both inflammatory and noninflammatory lesions in truncal acne.18 Importantly, unlike facial acne, truncal acne often affects a large body surface area, which can create difficulty with applying a topical treatment consistently in some patients; oral therapy is often utilized for management of truncal acne due to ease of use and the perception of clinicians that oral therapy is often needed to obtain efficacy, especially for moderate-to-severe acne.1,9,19 Thus, oral antibiotics, isotretinoin, or spironolactone with or without COCs (in women) remain preferred treatment options, with treatment selection based on patient-specific factors; with an oral antibiotic such as sarecycline, or with spironolactone, combination treatment with topical therapy is often a rational approach.2,9
Current broad-spectrum oral antibiotics prescribed for moderate to severe acne may be limited by side effects and bacterial resistance to antibiotics.3,4 By contrast, narrow-spectrum antibiotics, including sarecycline, exhibit less antibiotic selection pressure and have shown a low propensity to induce bacterial resistance.10 While further studies are needed to further confirm the minimal impact of sarecycline on the microbiome, the use of broad-spectrum tetracycline-class drugs such as doxycycline
