Home > Journals > Giornale Italiano di Dermatologia e Venereologia > Past Issues > Giornale Italiano di Dermatologia e Venereologia 2020 June;155(3) > Giornale Italiano di Dermatologia e Venereologia 2020 June;155(3):341-5

CURRENT ISSUE
 

JOURNAL TOOLS

eTOC
To subscribe
Submit an article
Recommend to your librarian
 

ARTICLE TOOLS

Publication history
Reprints
Permissions
Cite this article as

 

ORIGINAL ARTICLE   Freefree

Giornale Italiano di Dermatologia e Venereologia 2020 June;155(3):341-5

DOI: 10.23736/S0392-0488.20.06554-2

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Propylene glycol free 5% minoxidil lotion formulation: cosmetic acceptability, local tolerability, clinical efficacy and in-vitro skin absorption evaluations

Mauro BARBARESCHI 1, Veronica VESCOVI 2, Michela STARACE 3, Bianca M. PIRACCINI 3, Massimo MILANI 4

1 Clinic of Dermatology, University of Milan, Milan, Italy; 2 Service of Outpatient Dermatology of Parma, Parma, Italy; 3 Department of Dermatology, University of Bologna, Bologna, Italy; 4 Cantabria Labs Difa Cooper, Caronno Pertusella, Varese, Italy



BACKGROUND: A new propylene glycol (PG)-free 5% minoxidil (Mnx) lotion has been recently commercialized. Aim of this study was to evaluate the acceptability/tolerability and clinical efficacy of 3-month application of this new PG-free Mnx lotion and the penetration of the active compound in a reconstructed human epidermis (RHE/Episkin) model in comparison with a PG Mnx 5% lotion.
METHODS: Thirty subjects of both sex with a diagnosis of AGA were enrolled in the trial. Cosmetic acceptability and clinical efficacy were evaluated after 4, 8 and 12 weeks of treatment. Global tolerability was evaluated at week 12. Cosmetic acceptability evaluation was assessed using a 7-item questionnaire using a 10-point scale score. Global Tolerability was evaluated with a 4-grade scale. Clinical efficacy was evaluated with a 5-grade scale. Skin absorption of PG-free Mnx was evaluated and compared with a PG Mnx solution using the Episkin model.
RESULTS: All subjects concluded the study. The 7-item questionnaire mean values were always <2 at each time-point evaluation, demonstrating high cosmetic acceptability/tolerability. No subjects reported burning, itching or redness sensations. Global Tolerability score mean±SD value was 1.7±0.4. Clinical efficacy scores were 0.4, 0.6 and 1.2 at week 4, 8 and 12, respectively. PG-free Mnx showed similar amount of absorbed dose in comparison with PG Mnx.
CONCLUSIONS: This new PG-free lotion shows a very good cosmetic acceptability/tolerability profile. Clinical efficacy was also documented. The skin penetration of this formulation is comparable to the PG Mnx lotion, supporting the bioequivalence of the two products.


KEY WORDS: Minoxidil; Propylene glycol; Epidermis

top of page