Table 2.
Summary of clinical trials for management of truncal acne.
| Drug (Trade Name) | Company | Clinical Trial Number | Phase and Status | Study Design | Results |
|---|---|---|---|---|---|
| Topical management | |||||
| Dapsone 7.5 % gel (Aczone®) | Almirall | NCT02944461 | Phase 4, completed | A 16-week open label pilot study (n = 20) with moderate truncal acne | At week 16, 46.7% showed at least two grade improvement and a rating of clear or almost clear on the investigator global assessment (IGA) scale. |
| Azelaic acid 20% cream (Skinoren®) | GSK | N/A | Phase 4, completed | A prospective, noninterventional multicenter study in adult female patients (n = 251) with mild to moderate acne | A significant improvement of acne on the face, chest, and back was observed after 12 weeks of the treatment. |
| Tazarotene foam and gel (Tazorac®) | GSK | NCT01019603 | Phase 1, completed | A single-center, randomized, open-label, comparative bioavailability study in subjects with moderate to severe acne vulgaris (n = 30) | Mean concentration of tazarotene was higher for gel versus foam. |
| Trifarotene (Aklief®) | Galderma |
NCT02189629 NCT02566369 NCT02556788 |
Phase 3, completed Phase 3, completed |
An open-label, 52-week study with moderate facial and truncal acne (n = 453) Two double-blind, randomized, vehicle-controlled, 12-weeks studies of trifarotene cream versus vehicle in moderate facial and truncal acne |
66.9% patients with truncal acne demonstrated treatment success by physician’s global assessment rating (no or almost no acne). A highly significant difference in favor of trifarotene compared to the vehicle was observed based on physician’s global assessment and the change in inflammatory and noninflammatory lesion counts. |
| Cortexolone 17a-propionate (CB-03-01) 1% cream (Clascoterone®) | Cassiopea S.p.A. | NCT02682264 | Phase 3, completed | An open-label, long-term extension study (n = 609) to evaluate safety with acne | The 1% clascoterone cream showed a well-tolerable safety profile. |
| Systemic management | |||||
| Sarecycline (Seysara®) | Almirall |
NCT02322866 NCT05010538 |
Phase 3, completed Phase 4, Active, not recruiting |
Two double-blind, randomized, 12-week studies of sarecycline in the treatment of acne A 12-week, single center open-label case series study for truncal acne (n = 10) |
The pooled analysis for truncal acne showed that chest and back IGA success rate was significantly greater with sarecycline than with the placebo at week 3, 6, and 12, respectively. |
| Isotretinoin-Lidose (Absorica®) | Galephar | N/A | Phase 3, completed | A 20-week, multicenter, double-blind randomized study to evaluate the safety and efficacy of isotretinoin-lidose in patients with severe recalcitrant nodular facial and truncal acne (n = 925) | The mean change in facial and truncal nodular lesion counts from week 0 to week 20 was comparable between the isotretinoin-lidose group and the food-dependent generic isotretinoin group. |
| Drospirenone and Ethinyl Estradiol (YAZ®) | Bayer | NCT00722761 | Phase 3, completed | A single center, randomized double-blind, parallel group study in moderate truncal acne vulgaris (n = 30) | The drospirenone/ethinyl estradiol showed treatment success among 53.3% of the patients based on IGA and 60% of the patients based on subject global assessment. |
Abbreviation: N/A, not accessible.