ANTIBACTERIAL AND SEBOSUPPRESSIVE EFFICACY OF A COMBINATION OF CHLORAMPHENICOL AND PALE SULFONATED SHALE OIL - MULTICENTER, RANDOMIZED, VEHICLE-CONTROLLED, DOUBLE-BLIND-STUDY ON 91 ACNE PATIENTS WITH ACNE PAPULOPUSTULOSA (PLEWIG AND KLIGMANS GRADE II-III)

In a 3-armed, multicentre, randomized, double-blind, vehicle-controlle d study involving 91 patients with acne papulopustulosa, Plewig's grad e II-III, evidence could be provided of a significant reduction of the propionibacteria as well as a sebosuppressive effect (squalene reduct ion) under a combination of 1 % chloramphenicol (GAS 56-75-7) and 0.5 % pale sulfonated shale oil versus the alcoholic vehicle (1-2 mi twice daily). Likewise, monotherapy with chloramphenicol resulted in a sign ificant reduction in bacteria compared to the vehicle. The combination therapy was superior to the monotherapy with regard to the sebosuppre ssive effects. Based on a kinetics test carried out for a total of 2 h , a clinically relevant percutaneous absorption of chloramphenicol was ruled out. The chloramphenicol serum level was between < 5.0 mu g/l t o 180 mu g/l (average 25 mu g/l). This is important because with syste mic application (peroral, i.v.), the therapeutic chloramphenicol level is > 25 mg/l (25 000 mu g/l). None of the blood count and serum param eters were pathologically changed in a clinically relevant way before and after the therapy. An induction of resistance against chlorampheni col in the propionibacteria could be excluded. No adverse events and s ide effects occurred. The topical therapy of acne papulopustulosa with chloramphenicol as a monosubstance or in combination with pale sulfon ated shale oil represents an effective and safe local antibiotic treat ment possibility.