Real-World Effectiveness, Safety, and Tolerability of Cetosomal Minoxidil 5% Alone and a Fixed Drug Combination of Cetosomal Minoxidil 5% With Finasteride 0.1% in the Management of Androgenetic Alopecia (Inbilt Study)

Abstract

Introduction Topical minoxidil 5% is a widely used medication in the treatment of androgenetic alopecia (AGA) but is usually associated with adverse events (AE) such as scalp irritation, dryness, and itching. This prompted the development of nonalcoholic solutions, and cetosomal minoxidil was the most recent one. Methods Retrospective multicenter data analysis was conducted at 66 centers across India for adult AGA patients. Patients treated with either cetosomal minoxidil 5% alone (Group I) or a fixed drug combination of cetosomal minoxidil 5% and finasteride 0.1% (Group II) were analyzed for the effectiveness and safety of either formulation. The Physician Global Assessment (PGA) and Patient Global Assessment (PtGA) were used to assess each treatment’s effectiveness. Safety was reported by records of AE and a product tolerability assessment with subjective cosmetic acceptability as recorded by physicians. Results Of the 261 patients, 132 were in Group I, and 129 were in Group II. At 16 weeks, in PGA, mild to moderate improvement was noted in 48% and 32% of patients in Groups I and II, respectively, whereas significant to excellent improvement was seen in 52% and 68% of patients in Groups I and II, respectively. Similar results were noted for PtGA. In Group I, 64% of patients rated the product’s tolerability as excellent, and 69% reported the same in Group II. Meanwhile, 64% of patients in Group I and 74% in Group II rated the product as excellent in subjective cosmetic acceptability. Conclusions From real-world analysis, cetosomal-based minoxidil solutions were found to be effective and tolerable in AGA and could serve as therapeutic alternatives to alcoholic formulations for AGA management.

Comparative Clinical Study Evaluating the Efficacy and Safety of Topical 5% Cetosomal Minoxidil and Topical 5% Alcohol-Based Minoxidil Solutions for the Treatment of Androgenetic Alopecia in Indian Men

“…However, compared to traditional minoxidil, the unique cetosomal minoxidil seems to have a few advantages, including the absence of propylene glycol (implicit inconvenience) and a quicker time to dry after application. In a recently published real-world analysis, cetosomal minoxidil solutions were found to be effective and tolerable in AGA [20]. In our study, there were no statistically significant differences between the two groups in terms of efficacy for any of the parameters.…”