Table 4.

Summary of comparative investigations of BPO/clin or BPO/erythro combination therapies vs monotherapy of either drug’s constituents and vehicle

Study	Drug	Study design	Study length	Study size (n)	Major results	Safety/AE	Other comments
Lookingbill et al44	BPO/clin (5%/1%) vs monotherapy of BPO (5%) or clin (1%) or vehicle	Two double-blind, randomized, parallel, controlled	11 weeks	334	BPO/clin showed greater efficacy than monotherapy of BPO, clin, or vehicle	Excellent overall tolerance reported in 95% of patients; no difference in AEs in active drug arms	Concluded that combination BPO/clin is superior to either drug alone
Leyden et al45	BPO/clin (5%/1%) vs monotherapy of BPO (5%) or clin (1%) or vehicle	Multicenter, randomized, double-blind	10 weeks	480	BPO/clin more effective than monotherapy of BPO, clin, or vehicle	Similar AEs in all arms of study; most common AE was skin dryness	Concluded combination BPO/clin as an alternative treatment for moderate to moderately severe acne
Leyden et al46	BPO/clin (5%/1%) vs BPO (5%) or BPO/erythro (5%/3%)	Randomized, multicenter, single-blind	10 weeks	492	BPO/clin showed greater reduction than BPO in inflammatory lesions and was not more efficacious than BPO/erythro	AEs similar in all arms; dry skin most frequently reported in all arms	Concluded BPO/clin combination more effective than BPO alone and at least as effective as BPO/erythro
Tschen et al47	BPO/clin (5%/1%) vs BPO (5%) vs clin (1%) vs vehicle	Randomized, multicenter, double-blind, parallel-group	10 weeks	278	BPO/clin reduced inflammatory lesions more than either drug alone; BPO/clin reduced comedones more than clin or vehicle	Dry skin most frequent AE overall and more common in BPO/clin and BPO	Concluded BPO/clin more effective than monotherapy of either drug, especially for inflammatory acne
Thiboutot et al48	BPO/clin (2.5%/1.2%) vs BPO (2.5%) vs clin (1.2%) vs vehicle	Multicenter, randomized, double-blind, active- and vehicle-controlled, parallel-group, comparative	12 weeks	2813	BPO/clin was more effective at treating both noninflammatory and inflammatory lesions than either drug alone or vehicle	BPO/clin preparation was well-tolerated, and the AEs reported were reported as mild to moderate	BPO/clin is a safe, effective, and well-tolerated agent for the treatment of moderate to severe acne
Cunliffe et al49	BPO/clin (5%/1%) vs clin 1% gel	Double-blind, randomized, parallel-group	16 weeks	70	BPO/clin reduced number of Propionibacterium acnes and clin-resistant P. acnes; clin monotherapy increased bacteria count; BPO/clin showed better efficacy than clin	Both preparations were well-tolerated	Decreasing P. acnes and clin-resistant P. acnes counts correlated with the reduction in total acne lesions
Chalker et al51	BPO/erythro (5%/3%) vs BPO (5%) vs erythro (3%) vs vehicle	Double-blind, controlled	10 weeks	165	BPO-containing products reduced comedones more effectively than erythro alone; reduced pustules, papules, and inflammatory lesions	No AEs reported	BPO/erythro more effective than either drug alone, especially for inflammatory lesions

Abbreviations: AE, adverse effect; BPO, benzoyl peroxide; BPO/clin, benzoyl peroxide/clindamycin phosphate combination medication; BPO/erythro, benzoyl peroxide/erythromycin combination medication; clin, clindamycin phosphate; erythro, erythromycin.