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

January 2022 in “ Journal of Pharmaceutical Sciences ”

Anna Runnsjö, Susanna Liljedahl, David Sagna, Maria Ekblad, Jan Alenfall

microparticle-based formulation FOL-005 small peptide androgenetic alopecia topical delivery Minoxidil hair growth stimulant skin permeation hair growth study pig skin mouse hair growth study scalp skin microparticle formulation topical treatment Rogaine skin absorption

Studysummary This study developed a stable, cosmetically appealing formulation for the topical delivery of the peptide FOL-005, enhancing skin permeation and maintaining stability by keeping the peptide solid and in a water-free environment with particle sizes under 10 µm.

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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.