Evidence map›Paper›PMID 34634163›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2022

Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial.

B M Piraccini, U Blume-Peytavi, F Scarci, J M Jansat, M Falqués, R Otero, M L Tamarit, J Galván, V Tebbs, E Massana and 1 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 58 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 6 pooled it
19.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 6 syntheses or guidelines pooled it, 149 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 4 countries.

B M PiracciniDermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0001-6537-9689
U Blume-PeytaviDepartment of Dermatology, Venerology and Allergology, Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0003-3528-3752
F ScarciAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.
J M JansatAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.ORCID https://orcid.org/0000-0001-7578-5162
M FalquésAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.
R OteroAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.
M L TamaritAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.
J GalvánAlmirall Global Medical Affairs Department, Barcelona, Spain.
V TebbsIsland View Consulting Ltd., Dronfield, UK.
E MassanaAlmirall Research and Development Center, Sant Feliu de Llobregat, Barcelona, Spain.
Topical Finasteride Study Group
Almirall (Spain) · ESClinical Research Center for Hair and Skin Science · DESeascape Consultants (United Kingdom) · GBUniversity of Bologna · IT

Funding

Almirall S.A.Polichem S.A
6 · The paper itself

Abstract

backgroundOral finasteride is a well-established treatment for men with androgenetic alopecia (AGA), but long-term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles.

objectivesTo evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride.

methodsThis randomized, double-blind, double dummy, parallel-group, 24-week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone and dihydrotestosterone (DHT) concentrations were measured.

resultsOf 458 randomized patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs. 6.7 hairs; P < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at week 12 and investigator-assessed change from baseline in patient hair growth/loss at week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs. 55.6%), with topical vs. oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride.

conclusionTopical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations.

Indexed as

AlopeciaFinasterideAdultDihydrotestosteroneDouble-Blind MethodHairHumansMaleDihydrotestosteroneFinasteride

Identifiers

PMID34634163
PMCPMC9297965
OpenAlexW3207776435

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.