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Use of 5% Topical Minoxidil Application for Telogen Effluvium: An Open-Label Single-Arm Clinical Trial.

Manabu Ohyama, Ryokichi Irisawa, Masaki Uchiyama, Miho Mori, Kazuhiro Aoki et al.
Other The Journal of dermatology 2025
PubMed DOI CC-BY PDF
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Study Design

연구 유형
clinical trial
표본 크기
12
기간
24 weeks
중재
Use of 5% Topical Minoxidil Application for Telogen Effluvium: An Open-Label Single-Arm Clinical Trial. 5% topical minoxidil lotion 1mL applied to entire scalp twice daily
대조군
Placebo
효과 방향
Positive
비뚤림 위험
High

Abstract

Telogen effluvium (TE) is an acute and diffuse hair loss due to an abnormal increase in telogen hair follicles in response to external or internal factors. Recently, TE attracts global interest as a major cause of hair loss as a sequela of COVID-19. Typically, hair shedding in TE is expected to cease around 3-6 months from the onset with spontaneous hair regrowth, once the triggering factor is eliminated. However, the substantial shedding causes heavy psychological stress on patients, and there is no evidence-based treatment. To assess the usefulness of topical minoxidil, which has been reported to improve the hair cycle, for TE, an open-label, single-arm clinical trial was conducted enrolling 12 Japanese subjects (3 men and 9 women) who were diagnosed as TE by experts. For each subject, 1 mL of 5% topical minoxidil lotion was applied to the entire scalp twice daily for 24 weeks. Phototrichogram detected that the terminal hair (≥ 60 μm in diameter) count markedly increased respectively by 12.55 ± 4.99 hairs/cm2 at week 4 and 11.20 ± 4.79 hairs/cm2 at week 12 from baseline. In the hair wash test assessment, nearly 70% of the subjects were evaluated as improved at least by 2 grades in the evaluation scale (more than 100 shed hair decrease in the count) from baseline. Of note, all investigators and subjects reported notable improvement at week 24 respectively in their reported outcomes. Adverse event was minimal and within the known safety profile of topical minoxidil. Self-healing nature of TE and small sample size represented major factors affecting the validity of the study. Considering its safety profile and wide-availability, topical minoxidil lotion may be helpful in the management of TE making the patients reassured at earlier stage of clinical course. Still, it should be noted that this application is an off-label use.

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Figures

Tables

TABLE 1

GradeNumber of hairs collected
I< 10
II10 ≤ and < 50
III50 ≤ and < 100
IV100 ≤ and < 150
V150 ≤ and < 200
VI200 ≤ and < 250
VII250 ≤ and < 300
VIII300 ≤ and < 400
IX400 ≤ and < 500
X500 ≤

TABLE 2

Subject IDSexAgeFactors causing telogen effluviumOnset period (The time when hair loss symptoms began) [The number of weeks counted backward]Hair countTelogen hair ratio [%]Hair wash test
Non vellus [/cm2]Vellus [/cm2]Terminal [/cm2]Nonterminal [/cm2]Total [/cm2]InvestigatorSubject
TR‐01Male48Febrile illness (COVID‐19)Unclear (visited 16 weeks after COVID‐19)107.854.179.782.2161.918.1VIVI
TR‐02Male50Appendectomy16167.328.1142.752.7195.412.1IVVI
TR‐03Female45Febrile illness (COVID‐19)10164.969.9133.9100.9234.712.2VIVI
TR‐04Female56Psychological stress30128.050.254.6123.5178.15.4IVIV
TR‐05Male36Psychological stress25165.439.9149.655.6205.24.6IIII
TR‐06Female63Crash diet17127.032.596.563.0159.47.2VIIV
TR‐07Female42Febrile illness (COVID‐19)20195.937.9135.897.9233.810.0IIIII
TR‐08Female55Psychological stress12191.448.7126.5113.7240.216.3IIIV
TR‐09Female57Febrile illness (excluding COVID‐19)7194.99.8169.335.4204.711.9VIIIIV
TR‐10Female42Febrile illness (COVID‐19)17220.019.2190.049.2239.25.9VIII
TR‐11Female33Psychological stress8108.850.286.172.8159.027.8II
TR‐12Female45Febrile illness (COVID‐19)8217.066.9133.9150.1284.017.1IIII

TABLE 3

Subject IDSexAgeAdverse eventSeveritySeriousnessCausalityTreatment of Investigational drugOutcome
TR‐03Female45Fibula fractureSevereSeriousNot relatedNo changeResolved
TR‐04Female56Contact dermatitisModerateNonseriousRelatedTerminationResolved
TR‐05Male36Increase in serum aspartate aminotransferaseMildNonseriousNot relatedNo changeResolved
Increase in serum C‐reactive protein levelMildNonseriousNot relatedNo changeResolved
PyrexiaMildNonseriousNot relatedNo changeResolved
TR‐11Female33Glucose urine presentMildNonseriousNot relatedNo changeResolved
TR‐12Female45VomitingMildNonseriousNot relatedNo changeResolved
Abdominal painMildNonseriousNot relatedNo changeResolved

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