A randomized, double-blind comparison of a clindamycin phosphate/benzoyl peroxide gel formulation and a matching clindamycin gel with respect to microbiologic activity and clinical efficacy in the topical treatment of acne vulgaris.
BACKGROUND
One approach to suppressing the overgrowth of antibiotic-resistant bacteria is to develop combination products composed of active constituents with complementary but distinct mechanisms of antibacterial action.


OBJECTIVE
The purpose of this study was to compare the antimicrobial and clinical efficacy and tolerability of clindamycin phosphate 1%/benzoyl peroxide 5% gel formulation with matching clindamycin 1% gel in the treatment of acne vulgaris.


METHODS
This 16-week, single-center, double-blind, randomized, parallel-group study compared the combination gel with clindamycin monotherapy applied BID in patients 13 to 30 years of age with mild to moderate acne and facial Propionibacterium acnes counts > or = 10(4) colony-forming units per square centimeter of skin.


RESULTS
Seventy-nine patients were enrolled and randomly assigned to receive the combination gel (n = 40) or clindamycin monotherapy (n = 39). Seventy patients (50 males, 20 females; mean age, 18.2 years) were included in the intent-to-treat group. The combination gel treatment produced significantly greater reductions (P < or = 0.046) from baseline in total lesion counts and in numbers of inflammatory lesions and comedones compared with clindamycin monotherapy. Greater reductions in the severity of acne also were observed in the physician's and patient's Clinical Global Improvement scale scores and in other secondary efficacy measurements. Reductions in clindamycin-resistant P acnes counts were observed relative to baseline in the combination gel group; in contrast, P acnes counts increased by >1,600% in the clindamycin monotherapy group at week 16 (P = 0.018 vs combination gel). Reductions in inflammatory (r2 = 0.31; P = 0.016) and total (r2 = 0.28; P = 0.027) lesions were correlated with decreases in clindamycin-resistant bacteria. Also, significant correlations were observed between the percent change from baseline in total lesion counts (r2 = 0.44; P < 0.001) and comedo counts (r2 = 0.50; P < 0.001) and the log10 change from baseline in total P acnes counts.


CONCLUSIONS
The total P acnes count (P = 0.002) and the clindamycin-resistant P acnes count (P = 0.018) were significantly reduced after 16 weeks of treatment with combination gel compared with clindamycin monotherapy. These reductions in total P acnes and clindamycin-resistant P acnes counts correlated with reductions in total acne lesions.
Cunliffe
William J
WJ
Department of Dermatology, The General Infirmary, Leeds, United Kingdom.
Holland
Keith T
KT
Bojar
Richard
R
Levy
Sharon F
SF
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000382:microbiology; D000287:Administration, Topical; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001585:Benzoyl Peroxide / Q000008:administration & dosage* / Q000627:therapeutic use; D002981:Clindamycin / Q000008:administration & dosage* / Q000627:therapeutic use; D015169:Colony Count, Microbial; D004311:Double-Blind Method; D004338:Drug Combinations; D024881:Drug Resistance, Bacterial; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D008297:Male; D011425:Propionibacterium acnes / Q000187:drug effects / Q000302:isolation & purification; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D002981:Clindamycin; D001585:Benzoyl Peroxide