Is Alcohol-Free Minoxidil Effective?

Traditional Minoxidil formulations commonly known as Rogaine in the United States or Regaine in Australia contain on average 32.5% alcohol and can reach as high as 70%. These older formulations rely heavily on alcohol and propylene glycol to bring complete drug dissolution and prevent crystallisation.

Alcoholic formulations in the form of 2% and 5% solution and 5% foam were approved by the FDA in 1988, 1991, and 2016, respectively for the management of male pattern baldness.

This article will focus on:

• What is the role of alcohol in these formulations?
• Is alcohol-free minoxidil effective?
• What are the benefits of alcohol-free minoxidil?
• Are all alcohol-free formulations the same?

 

Rogain, Regain, HairAgain and friends ...

Regain is a popular minoxidil product sold in Australian pharmacies. It is known by the name Rogain in the United States and other parts of the world. Since the patent for Rogain expired, other brands have marketed their own version, all with the same formulation.

 

What is the purpose of alcohol and propylene glycol?

Minoxidil is not soluble in water and requires the addition of propylene glycol and alcohol to completely dissolve in solution.

 

 

Studies comparing different delivery solvents found that ethanol and propylene glycol also had the highest rate of drug penetration through the stratum corneum (aka top layer of the skin). Does greater penetration equal better results?

Not necessarily. Think of penetration as getting through the door. Once you walk through the door, you want to be able to move to the other side of the room freely. In science, this is described as the drug's diffusion co-efficient or diffusivity. There is no direct relationship between penetration and diffusivity.

According to historical studies, the dose-response effect of Minoxidil starts to plateau from 7.5% concentration because its maximum solubility in propylene glycol is 7.5%, after which Minoxidil can easily crystalise. Thus, higher concentrations exceeding 5% were found to cause more skin irritation as more alcohol was required to propel dissolution.

Defying traditions ...

Fast forward to 2023, Médicii Laboratories have been able to demonstrate that Minoxidil can be dissolved without propylene glycol and alcohol at 10% concentration for beard growth using Olevit™, a proprietary fatty acid distilled in glycerine.

 

Are Alcohol-Free Formulations Effective?

Udare et al. (2023) found that alcohol-free Minoxidil formulations provide remarkable benefits to patients with androgenic alopecia, also known as male pattern hair loss. The same study published in the International Journal of Trichology showed that patients had improved skin hydration, and reduced scalp inflammation and scalp itching when they used alcohol-free Minoxidil.

In contrast, alcohol-based formulations showed an increase in scalp redness and dryness after day 15 and day 30 respectively.

Another study published by Sattur et al (2023) found the alcohol-free group was better tolerated and there was similar hair growth between the alcohol-free group and the alcohol group over sixteen weeks.

 

Are all Alcohol-Free Formulations the same?

Not all alcohol-free formulations are the same.

• Some bulk ingredients contain a small amount of alcohol. These formulations are formerly known as hydro-alcoholic formulations. Whilst a small amount of alcohol is not enough to provoke sensitive skin, they are not truly alcohol-free.

• The ability for Minoxidil to leave the stratum corneum.

• other skin conditioning agents.

 

 

 

 

 References:

1.  Udare, S et al (2023). "Low-Alcohol or Alcohol-Free Minoxidil Formulation for the Management of Androgenic Alopecia: an Indian Perspective." International Journal of Trichology. 15(1): p13-17, Jan-Feb 2023.
2. Yan, H et al (2011). "Solubility of Minoxidil in Methanol, Ethanol, 1-Propanol, 2-Propanol, 1-Butanol, and Water from (278.15 to 333.15) K ." J. Chem. Eng. Data 2011, 56, 5, 2720–2722
3. Tata, S et al (1995). Penetration of Minoxidil from Ethanol/PG: Effect of application volume and occlusion. J Pharm. Sciences. v84(6). June 1995, Pages 688-691.
4. American Chemical Society
5. Sattur, S et al (2023). Sattur, S (2023). "Comparative clinical study evaluating the efficacy and safety of topical 5% Cetosomal Minoxidil and 5% Alcohol-Based Minoxidil Solutions for the treatment of androgenic alopecia in Indian Men." Cureus 15(10): e46568. doi:10.7759/cureus.46568