Clinical trials and experimental
Randomized comparative trial evaluating the efficacy and tolerance of a topical anti-inflammatory and antibacterial seboregulator (containing salicylic acid + zinc + 5 alpha avocuta), associating a topical antibiotic (Metronidazole), on subjects with mild to moderate acne vulgaris
Background: Acne vulgaris involves a disorder of androgenic controlled sebum secretion, leading to appearance of comedons, which then develop an inflammatory response through accumulation of compounds forming the sebum and of bacteria (Propionilbacterium acnes) developed in anaerobic environment, maintaining intrafollicular inflam-mation by their metabolic compounds. A triple approach is therefore useful, to decrease the sebum secretion, the inflammation and also the elimination of bacterial superinfection.
Objective: To evaluate the efficiency of topical substances consisting in antiinflammatory, antibacterial and seboregulative effect (Salicylic Acid-Zinc-Glycolic Acid-5 Alfa Avocuta), associated with a topical antibiotic, metronidazole, versus placebo (a neutral cream).
Methods: Unicentric, randomized, comparative trial, evaluating two symmetrical areas on 30 patients with mild to moderate acne vulgaris. First group of 15 patients were treated on half face with cleansing gel (1% Salicylic Acid, Zinc 0.5%) and anti-inflammatory and seboregulator Gel (Glycolic Acid 6%, Zinc 1%, 5 Alfa Avocuta1%), versus a neutral cream on the other half of the face. The other group of 15 patients were treated with the combination of a topical cleansing gel +Seboregulator and antiinflamatory gel + Metronidazole on half face versus Placebo (neutral cream) on the other half.
Results: The best response was obtained by using all three topicals in association: cleaning gel (Salicylic Acid 1%, Zinc 0.5%) + seboregulator anti-inflammatory gel (6.00% Glycolic Acid, Zinc 1%, 5 Alfa Avocuta 1%) + Metronidazole. Patients treated this way reacted positively faster (80% after the first 30 days and 20% after 60 days of treatment) than those treated with cleansing gel + seboregulator and anti-inflammatory gel (27% after 60 days and 73% after 90 days of treatment).
Conclusions: A more complex topical treatment associating Metronidazole gives faster results in acne vulgaris, and the patient become more optimistic, more confident and more patient to carry it all to an end.
