A 2% Oleosome-FGF-2 Fusion Extract Scalp Serum Improves Photo-trichogram-Derived Hair Density, Anagen/Telogen Ratio, Hair Shaft Thickness, and Scalp Barrier Parameters in Women with Shedding-Prone Hair: A Randomized, Single-Blind, Placebo-Controlled Pilot Study

Abstract

Alexandre Reeber*, Monica Bucchia, Samuele Burastero and Marzia Baldi

Background: Hair shedding, reduced perceived hair density, brittle hair prone to falling, and scalp discom-fort are common concerns in women. Objective instrumental methods such as digital phototrichogram can quantify hair density, anagen/telogen ratio, and hair shaft diameter, while scalp hydration, transepidermal water loss (TEWL), and sebum measurements can characterize scalp barrier status. Objective: To evaluate the efficacy of a 2% Oleosome-FGF-2 fusion extract scalp serum compared with placebo on hair density, anagen/telogen ratio, hair shaft thickness, and scalp biophysical parameters over 84 days.

Methods: This randomized, single-blind, placebo-controlled pilot study enrolled 40 healthy female volunteers with telogen effluvium and/or brittle hair prone to falling out, ideally with dry or sensitive scalps. Participants received either 2% Oleosome-FGF-2 fusion extract Scalp Treatment (Serum A; n=20) or placebo scalp treatment (Serum B; n=20) and applied the product twice daily to the scalp for 84 days. Assessments were performed at baseline (T0), day 28 (T28), day 56 (T56), and day 84 (T84). Instrumental endpoints included anagen/telogen ratio, hair density, and shaft thickness using C-CUBE Pixience digital imaging, scalp hydra-tion by Corneometer CM825, TEWL by Nano-Tewameter TM300, and sebum level by Sebometer SM815. Clinical hair-density scoring was performed at T0 and T84 using a 5-point Likert scale aligned with Lud-wig-type clinical assessment.

Results: At T84, Serum A increased anagen/telogen ratio by 17.0% versus -2.6% with placebo, hair density by 33.5% versus 7.2%, hair shaft thickness by 10.6% versus -1.6%, and scalp hydration by 22.2% versus -2.9%. Serum A reduced TEWL by 27.2% versus a 9.2% reduction with placebo and reduced sebum level by 30.2% versus a 2.7% increase with placebo. Between-group comparisons favored Serum A for anagen/telogen ratio at T56 and T84, hair density at T28, T56, and T84, hair shaft thickness at T84, TEWL at T56 and T84, sebum at T56 and T84, and clinical hair-density assessment at T84. Hydration differed significantly between groups at baseline and at all post-baseline time points. Clinical hair-density scores improved in 90% of Serum A par-ticipants and 35% of placebo participants at T84.

Conclusion: In this exploratory randomized placebo-controlled pilot study, twice-daily use of a 2% Oleo-some-FGF-2 fusion extract scalp serum for 84 days was associated with improved phototrichogram-derived hair density, anagen/ telogen ratio, hair shaft thickness, and scalp barrier parameters compared with placebo. Larger double-blind studies with prespecified primary endpoints, individual-level datasets, and longer fol-low-up are warranted.

HTML PDF