CARETOPIC: finasteride spray for hair loss in men — what the studies showed

Key points

CARETOPIC is a finasteride scalp spray: it acts on follicles locally, and noticeably less of the drug enters the body than with the tablet.

What it is and how it works

Male pattern hair loss (androgenetic alopecia) is linked to dihydrotestosterone (DHT), which the enzyme 5-alpha-reductase type 2 makes from testosterone. Balding areas contain more DHT, and the hair follicles shrink: the hair grows thinner and shorter. Finasteride blocks this enzyme and inhibits the shrinking of follicles, which may reverse the hair loss (CARETOPIC leaflet, Italian regulator AIFA).

Each mL of solution contains 2.275 mg of finasteride; one spray delivers 50 µL, that is 114 µg; the 18 mL bottle holds 180 sprays. Vehicle: ethanol 96%, propylene glycol, hydroxypropyl chitosan, water. Dispensed on prescription.

What the studies showed

A randomised phase 3 trial: 458 men, 45 sites in Europe, 24 weeks, spray vs placebo; the 1 mg tablet was included for comparison. Hair count in the 1 cm² target area rose by an average of 20.2 with the spray and 6.7 with placebo (baseline about 200 in the spray group). The advantage was significant as early as week 12. Adverse events did not differ meaningfully between spray and placebo, and no serious treatment-related events occurred (Piraccini BM, J Eur Acad Dermatol Venereol 2022. PMID 34634163^[1]).

In an early study, 32 men were split into five groups (about 6 each): 100, 200, 300 or 400 µL of a 0.25% solution (the same as in CARETOPIC: 2.275 mg per mL) or a vehicle without the drug, once daily for 1 week. At 100 and 200 µL, scalp DHT fell on average by 47% and 52%, serum DHT by 24% and 26%; with the vehicle by 5.6%. Blood testosterone did not change notably (Caserini M, Int J Clin Pharmacol Ther 2016. PMID 26636418^[2]). A review of 7 studies of various forms of topical finasteride (CARETOPIC is not singled out): hair loss decreased and hair counts rose; the data are preliminary and limited (Lee SW, J Drugs Dermatol 2018. PMID 29601622^[3]).

How to use it

• Preparation. Assemble the pump spray and cone. Before first use, press 4 sprays into the sink (then rinse the sink).
• Application. Once a day to the balding areas — 1–4 sprays (50–200 µL) on separate, non-overlapping spots, no more than 4; hair and scalp dry. Press the cone firmly against the scalp; for 2–4 sprays, move it to a neighbouring spot. Do not spray towards the face and do not apply with fingers; if it gets on other body parts, wash it off. Until the solution dries, avoid contact with pillows and hats; it should stay on the scalp for at least 6 hours.
• How long to wait. Usually 3–6 months of daily use before hair growth appears; continuous use is recommended. There is no clinical experience beyond 6 months.
• The bottle. 180 sprays; after opening, use for no longer than 6 months and no more than 180 sprays, otherwise the dose may be insufficient.

Who it suits

Men aged 18–41 with mild to moderate androgenetic alopecia; the product is indicated only for it (CARETOPIC leaflet). Long-term tablet therapy does not suit everyone; the spray was created so that less of the drug reaches the body (Piraccini BM, J Eur Acad Dermatol Venereol 2022. PMID 34634163^[1]). If the cause is unclear, first rule out iron deficiency and thyroid problems: “Hair falling out and nails breaking: which tests to get”. CARETOPIC is available in our shop; the prescription and regimen are agreed at a consultation.

How it differs from the tablet

The 1 mg tablet acts through the blood on the whole body, the spray on the scalp. Peak plasma finasteride with the spray was more than 100 times lower, and serum DHT fell by 34.5% vs 55.6% (Piraccini BM, J Eur Acad Dermatol Venereol 2022. PMID 34634163^[1]). DHT dropped below normal by week 24 in 15.3% on the spray and 55.2% on the tablet (CARETOPIC leaflet). In effect on hair the spray is numerically similar to the tablet, but the tablet was compared only descriptively, without statistical testing. The leaflet calls the fall in blood DHT clinically significant with the spray too: systemic adverse effects are possible, though less likely. Sexual adverse events occurred in 2.8% on the spray, 3.3% on placebo (at placebo level) and 4.8% on the tablet (leaflet); a 2026 systematic review gives the same figures from the phase 3 trial (Złotowska A, Front Med (Lausanne) 2026. PMID 42396141^[4]). Other options tested in people are in the article “Eastern Remedies for Hair Loss”.

Who must not use it and who should see a doctor first

• Who must not use it. The product is not intended for women; it is contraindicated in pregnant women, those who may become pregnant, and anyone allergic to the ingredients. Pregnant women, those who may become pregnant and children under 18 must not touch the product or the treated scalp (risk to a male fetus); after accidental contact the area is washed. Safety and efficacy in children have not been established (CARETOPIC leaflet).
• See a doctor first. If the scalp is damaged: the alcohol may cause burning, and the low absorption was shown for intact skin (CARETOPIC leaflet); if the hair loss does not look androgenetic; if other scalp products are needed — their combined use has not been studied, and the leaflet advises not to apply them to the treated areas; the result is best assessed with a doctor after 3–6 months.
• PSA test. There are no data on the effect of the spray on PSA (prostate-specific antigen); this is taken into account when interpreting the test. Any breast changes — lumps, pain, nipple discharge — should be reported to a doctor at once (CARETOPIC leaflet).