Both TGM 0.04% and TGM 0.1% were associated with a reduction from baseline in total, inflammatory, and noninflammatory lesions. Patients ranged in age from 12 to 41 years (mean, 18.4 years) and were predominantly white (n = 89 ) and male (n = 80 ). One hundred fifty-six patients (78 TGM 0.04%, 78 TGM 0.1%) were randomized and received treatment. Adverse events (including severity and relationship to treatment) and signs and symptoms of cutaneous irritation at the treatment site were monitored at each study visit. End points were the acne lesion count (total, inflammatory, and noninflammatory lesions) and the investigators' and patients' assessments of improvement. All other topical medications applied to the face (including corticosteroids, antimicrobials, salicylic acid, and benzoyl peroxide) were to be discontinued at least 2 weeks before the study. Patients must have discontinued systemic retinoid treatment for at least 1 year before the study and were not to have used any topical retinoids, systemic antibiotics, nicotinamide, or systemic steroids for at least 1 month. In this multicenter, double-blind, parallel-group, Phase IV dose-ranging study, patients with facial acne were randomized to apply either TGM 0.04% or TGM 0.1% to the face each night for 12 weeks. This study was conducted to assess the efficacy and safety profile of a lower-dose TGM (0.04%) formulation compared with TGM 0.1% for the treatment of mild to moderate acne vulgaris. A lower-strength TGM formulation may be desirable to further reduce exposure to tretinoin. Tretinoin gel microsphere (TGM) formulations were developed to minimize these effects. Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritation, including erythema, peeling, dryness, burning, and itching.
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