A Novel Microparticle-Based Formulation for Topical Delivery of FOL-005, a Small Peptide

The document presents a study on a novel microparticle-based formulation for the topical delivery of FOL-005, a small peptide, for the treatment of androgenetic alopecia. The formulation was designed to be stable, skin-compatible, and cosmetically appealing. The peptide was kept in a solid form in a water-free environment and reduced to a particle size of less than 10 µm. The formulation was tested on pig skin, in a mouse hair growth study, and on 210 subjects with androgenetic alopecia for 4 months. The results showed that the formulation was stable, the peptide could permeate the skin, and it stimulated hair growth. The highest dose of FOL-005 showed similar hair growth stimulation potential as Minoxidil, a common hair growth stimulant. The formulation was found to be physically and chemically stable after 2 years of storage at 2-8°C and 25°C. A user study showed that 77% of patients found the formulation easy to apply, 75% did not have to wash their hair more frequently, and 76% perceived no negative effects on the scalp skin.