Efficacy and safety of topical tretinoin 0.1% cream in facial skin aging in Indian subjects: A prospective open-label study

Objectives: To evaluate the clinical efficacy, safety, and instrumental outcomes of topical tretinoin 0.1% cream in the treatment of facial skin aging. Material and Methods: This prospective, single-arm study enrolled 40 subjects with visible signs of facial aging; 39 subjects completed the 16-week treatment period. Clinical assessments included wrinkle, photoaging grade, skin texture/roughness, pigmentation, pore visibility, and investigator global assessment parameters such as redness, dullness, oiliness, dryness, and skin laxity. Instrumental evaluations measured melanin index, erythema, sebum levels, skin hydration, wrinkle depth, skin texture, and pore volume using objective imaging and skin analysis devices. Patient-reported outcomes included treatment satisfaction and Global Aesthetic Improvement Scale scores. Results: Following 16 weeks of treatment, significant improvements were observed in wrinkle severity, skin texture, photoaging grade, and pore visibility. Instrumental assessments demonstrated reductions in melanin levels, erythema, and sebum production across facial sites ( p < 0.001). Skin hydration increased significantly, while wrinkle depth, skin texture irregularity, and pore volume decreased significantly ( p < 0.001). The treatment was well tolerated, with only mild local reactions such as erythema, scaling, dryness, and transient burning. Conclusion: Topical tretinoin 0.1% demonstrated significant improvements in multiple clinical and instrumental parameters of facial aging with good tolerability, supporting its effectiveness as a high-strength anti-aging therapy in clinical practice.