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Background: Topical retinoid and antibacterial agents are commonly used as first-line treatments in mild/moderate acne vulgaris (AV). Adherence to retinoid treatment could be limited by the low local tolerability. Literature data show that up to 15% of patients prematurely stop the treatment with retinoids because of skin irritation. A medical device in gel formulation containing tretinoin (0.02%), glycolic acid (4%) and clindamycin (0.8%) is available. So far, no real-life, prospective data regarding efficacy and tolerability of this gel are available. We performed a prospective, multicenter, pragmatic 12-week, assessor-blinded trial. Primary outcomes were the changes of Total acne lesions (TL) count. Secondary outcomes were the evolution of Global Acne Grading System score (GAGS) e and Noninflammatory (NI-L) and Inflammatory (I-L) lesions count. An additional secondary outcome was also to evaluate the local tolerability of the gel. Materials and methods: In a real-life multicenter trial, 159 subjects with mild/moderate AV of the face were enrolled after their informed consent in a 12-week trial. Subjects were instructed to apply the gel once daily at evening.