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Updated: Feb 10, 2026

Targeted Expression of GFP in the Hair Follicle Using Ex Vivo Viral Transduction
Published on: March 17, 2008
New multi-targeting strategy in hair growth promotion: in vitro and in vivo studies
Barbara Marzani1, Daniela Pinto1, Elisabetta Sorbellini2
1Giuliani S.p.A., Milan, Italy.
Background:
Considering the importance of hair in our modern society and the impact of hair loss, the efforts of researchers are addressed to better understand the mechanisms behind the hair cycle regulation and dysregulation. Because hair loss is multifactorial, differenced and new approaches are required. In particular we addressed our attention to two recently identified targets in hair cycling and growth control: olfactory receptor and autophagy. The aim of the study was to evaluate: the possible pro-autophagic effect of N1-methylspermidine (a spermidine analogue) in vitro and, in a double blind clinical trial, the safety and efficacy of topical daily application of a lotion containing N1-methylspermidine and Sandalore®.
Methods:
Autophagic modulation by N1-methylspermidine was monitored in vitro by LC3 and p62 fluorescent signal cell line. Topical daily application of the lotion was tested in 60 male and female subjects with chronic telogen effluvium by means of non-invasive objective evaluation.
Results:
The results obtained by in vitro tests showed the capacity of N1-methylspermidine to increase autophagic process while the clinical trials performed confirmed the safety and anti hair loss efficacy of the lotion reporting a reduction of hair loss (modified wash test) and hair growth stimulation as evaluated by hair density, hair shaft diameter, % of anagen hair and Hair Mass Index increase after 3 months of treatment. The lotion efficacy remained statistically significant for the above-mentioned parameters, with the exception of hair lost during wash, also 3 months after the end of treatment.
Conclusions:
Based on the obtained results, the daily use of the N1-methylspermidine and Sandalore®-based lotion is efficient to counteract hair loss and increase hair growth by a multifunctional targeting approach.
Insights
N1-methylspermidine enhances autophagy, reducing hair loss and stimulating growth. A topical lotion containing N1-methylspermidine and Sandalore® proved safe and effective in clinical trials for hair regrowth.
Area of Science:
- Dermatology and Hair Biology
- Cellular Biology and Molecular Mechanisms
- Pharmacology and Cosmetology
Background:
- Hair loss is a significant concern, prompting research into hair cycle regulation and dysregulation.
- Novel therapeutic targets, including olfactory receptors and autophagy, are emerging for hair growth control.
- N1-methylspermidine, a spermidine analogue, is investigated for its potential pro-autophagic effects.
Purpose of the Study:
- To evaluate the in vitro pro-autophagic effect of N1-methylspermidine.
- To assess the safety and efficacy of a topical lotion containing N1-methylspermidine and Sandalore® in a clinical trial.
- To investigate the impact on hair loss and hair growth in subjects with chronic telogen effluvium.
Main Methods:
- In vitro monitoring of autophagic modulation using LC3 and p62 fluorescent signals.
- Double-blind, placebo-controlled clinical trial involving 60 male and female subjects.
- Non-invasive objective evaluations of hair loss reduction and hair growth stimulation.
Main Results:
- N1-methylspermidine demonstrated an increased autophagic process in vitro.
- The lotion significantly reduced hair loss and stimulated hair growth (density, diameter, anagen hair %, Hair Mass Index) after 3 months.
- Efficacy persisted 3 months post-treatment, except for hair lost during washing.
Conclusions:
- Daily application of the N1-methylspermidine and Sandalore® lotion is effective for counteracting hair loss.
- The lotion promotes hair growth through a multifunctional targeting approach.
- The study confirms the safety and anti-hair loss efficacy of the investigated topical treatment.
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