Table 2.

Results of long-term studies with A/BPO fixed-dose combination gel

Study	Type of study	Interventions (duration)	Total (n)	Summary of efficacy	Grade of evidence
Pariser et al31	Multicenter, open-label, single-arm	A/BPO (12 months, once daily)	452	Significant reduction of total lesion count. No subject discontinued because of lack of efficacy	B
Poulin et al13	Multicenter, double-blind, randomized, controlled	1. A/BPO 2. Vehicle (6 months, once daily)	243	Significantly higher lesion maintenance success rate in A/BPO side. A/BPO prevents the occurrence of relapse	A
Betolli et al40	Single-center, open-label, prospective-cohort, noncomparative study consisting of two phases (active treatment phase and a maintenance phase)	A/BPO (after a successful acne therapy with oral isotretinoin for 12 months, once daily)	69	Relapse of acne under A/BPO was 2.94%	C
Gollnick et al6	Multicenter, open-label, prospective noninterventional, observational cohort study	A/BPO (78.8%) monotherapy or A/BPO (21.2%) in combination with other drugs (8.8% topicals, 8.7% systemic antibiotics) (9 months, once daily)	5,131	No more visible acne lesions after applying A/BPO for a median time of 3 months in 8.2% of the subjects, after 9 months in 25.8%	C

Notes: Grade of evidence: A = randomized, double-blind clinical trial of high quality (eg, sample-size calculation, flow chart of patient inclusion, intention-to-treat [ITT] analysis, sufficient sample size). B = randomized clinical trial of lesser quality (eg, only single-blind, no ITT). C = comparative trial with severe methodological limitations (eg, not blinded, very small sample size). Adapted from Nast A, Dréno B, Bettoli V, et al. European evidence-based (S3) guidelines for the treatment of acne – update 2016 – short version. J Eur Acad Dermatol Venereol. 2016;30:1261–1268,14 with permission from John Wiley and Sons.

Abbreviation: A/BPO, adapalene 0.1%/benzoylperoxide 2.5%.