Dr. Rassman’s Comments: I saw Dr. Insalaco present these findings at a meeting last month in the United Kingdom. About 200 hair restoration surgeons attended the meeting. Her results (combining Finasteride and minoxidil in a drug formulation) was very impressive, reversing hair loss in various parts of the scalp over an 18 month period of time. Patient compliance was high and what was most interesting was that there were no sexual side effects reported in her 300 test population. I was so enthusiastic about this, that I asked her to write a short article for this blog. Based upon her work, I will start prescribing it to my patients who request it.
Personal experience with Local Finasteride
Chiara Insalaco, MD, PhD
Plastic and Reconstructive Surgeon
Hair Restoration Specialist
Finasteride, a synthetic 4-azasteroid compound, is an antiandrogen which acts by inhibiting 5-alpha reductase. This enzyme converts Testosterone to Dihydrotestosterone (DHT). It works by partly blocking the body’s production of the male hormone that causes the prostate to enlarge and in those with genetic balding, it is the hormone that induces hair loss.
In December 22nd 1997, the FDA approved finasteride (Propecia®) to treat male pattern hair loss.
Clinical Studies for PROPECIA® (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss shows that 3,8% of men experienced sexual adverse problems:
In 2011 the U.S. FDA conducted a post marketing evaluation of reported case of persistent sexual dysfunction after finasteride discontinuation. Of the 2527 cases, from 1997 to 2011, the FDA identified 59 reported cases of Sexual Disfunction (2.3% of cases) that lasted 3 or more months after Finasteride Discontinuation. FDA has required Merck to revise the Propecia label to disclose the post marketing sexual adverse events.
Shortly after Merck revised its label, THOUSANDS ( perhaps hundreds of thousands) of websites claim that Propecia and Finasteride cause erectile dysfunction and loss of libido; however, the drug has be used by millions of men, so that it was hard to connect the relationship when looking at the FDA 2.3% incidence of sexual side effects figure.
In Italy, in order to overcome the problem we came up with a new topical formulation
The aim was to achieve:
- Maximum absorption through the epidermal layer of the scalp
- Minimize the systemic absorption
The first study about topical finasteride is Italian and it was made in 1997: Mazzarella, G., Loconsole, G., Cammisa, G., Mastrolonardo, G. and Vena, G. (1997). Topical finasteride in the treatment of androgenic alopecia. Preliminary evaluations after a 16-month therapy course. Journal of Dermatological Treatment, 8(3), pp.189-192. The study was a single-blind, placebo-controlled, 16-month trial carried out in 52 patients with Alopecia Areata using a topical 0.005% finasteride solution. The results showed that the clinical outcome, in terms of both hair regrowth and balding areas reduction, seems to be encouraging, and it also showed an absence of either any evidence of percutaneous absorption of finasteride producing local/systemic untoward effects. In 1997 the FDA approved Propecia® to treat AGA so the study was forgotten!
There are few different compound formulations. They are not Over-the-Counter drugs which can be purchased without a prescription. Only few pharmacies in Italy are able to make it.
The most common for used in Italy is the Finasteride Liposomal Gel.? The liposomal vehicle has a high penetration capacity through the epidermis and it’s able to keep the drug locally in the skin for long time.
- It has a good aesthetic outcome
- It doesn’t make the hair greasy
This combination has results in good patient compliance
The Milan University evaluated 300 patients treated with the Finasteride Liposomal Gel.
The result: Systemic Absorption is limited to 1/18 compared to the Oral Finasteride dose of 1mg.
In my daily practice I combine both Minoxidil and Finasteride in the same lotion in order to have the maximum result. Before giving Local Finasteride I always request: (a) DHT (b) Testosterone levels and (c) Sperm Counts. So far none of my patients have shown any changes in these exams or reported any side effects.
There are new scientific studies showing that finasteride doesn’t cause Sexual Side Effects:
These studies suggest that:
- Men with Alopecia may be inherently more susceptible to sexual dysfunction regardless of treatment
- Sexual dysfunction is not uncommon in the general population regardless of alopecia status
Dr Chiara Insalaco