Which treatments for androgenetic alopecia are not FDA approved?

Updated: Mar 05, 2020
  • Author: Robert P Feinstein, MD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
  • Print

Some drugs are not approved by the FDA but are potentially helpful medications. [35] In women with androgenetic alopecia, especially those with a component of hyperandrogenism, drugs that act as androgen suppressants or antagonists (eg, spironolactone, oral contraceptives) may be beneficial. Evidence exists of an association between androgenetic alopecia, hypertension, and hyperaldosteronism. Spironolactone could play a dual role in treatment.

A literature review by Fields et al indicated that topical ketoconazole may provide an effective adjunctive or alternative therapy for androgenetic alopecia. Reports found an increase in hair shaft diameter in association with the agent, and photographic and subjective assessment revealed clinical improvement of the alopecia following treatment. [36]

Dutasteride is another possible treatment for androgenetic alopecia. This drug inhibits type I and type II 5-a reductase isoenzymes and is felt to be 3 times as potent as finasteride in inhibiting the type II enzyme and 100 times as potent in inhibiting the type I enzyme. A phase II study on the use of dutasteride in the treatment of alopecia was carried out in the United States, but no further trials are currently being conducted in the US. However, an ongoing trial is being conducted outside of the United States.

A report by Motofei et al suggested that finasteride is preferable to dutasteride as a therapy for androgenetic alopecia. The investigators stated that finasteride “preserves important physiological roles of dihydrotestosterone” unrelated to androgenetic alopecia and that it appears to have at least partially predictable adverse effects. [37]

A study by Singh et al suggested that botulinum toxin may be a viable treatment for androgenetic alopecia in males, since intramuscular infection of the drug into the scalp results in muscle relaxation and, therefore, increased blood flow. The study included 10 patients, with each of 30 sites in each patients’ scalp injected with 5 U of botulinum toxin. In eight patients, the investigators reported good to excellent results on photographic evaluation. [38]

Low-level laser light therapy, in particular a red light hairbrush–like device has been marketed as an over-the-counter technique for hair growth. In a double blind, sham-device controlled, multicenter, 26-week trial, 110 patients in the active treatment group who completed the study showed a significantly greater improvement in overall hair regrowth than did the sham group. [39] Marketed as the HairMax LaserComb, it has obtained 510K FDA approval for use as a medical device. Note that this approval refers to safety rather than actual efficacy and that the data required for medical devices are quite different from those required to demonstrate the safety and efficacy of drugs.

Topical latanoprost 0.1%, a prostaglandin analogue used to treat glaucoma, has been noted to cause an increase in the number, length, and thickness of eyelashes. Blume-Peytavi et al conducted a 24-week topical treatment with this agent to note the effect on androgenetic alopecia. Sixteen young men with mild androgenetic alopecia were studied. They applied latanoprost 0.1% and placebo daily on 2 minizones on the scalp. Measurements of the hair growth, density, diameter, pigmentation, and anagen/telogen ratio were performed throughout the study. At 24 weeks, an increase in hair density was noted at the latanoprost-treated site compared with baseline and the placebo site. They concluded that this medication could be useful for stimulating hair follicle activity and treating hair loss. [40]

Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!