Use of 5% Topical Minoxidil Application for Telogen Effluvium: An Open-Label Single-Arm Clinical Trial.
Study Design
- Studientyp
- clinical trial
- Stichprobengröße
- 12
- Dauer
- 24 weeks
- Intervention
- 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
- Vergleichsgruppe
- Placebo
- Wirkungsrichtung
- Positive
- Verzerrungsrisiko
- 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.
Full Text
Figures
FIGURE 1
Participant flow diagram for the open-label single-arm clinical trial of 5% topical minoxidil application for telogen effluvium.
flowchart
FIGURE 2
Hair density and shedding rate measurements at baseline and post-treatment in telogen effluvium patients using 5% topical minoxidil.
chart
FIGURE 3
Clinical or trichoscopic images showing hair recovery in telogen effluvium patients after topical minoxidil treatment.
photographTables
TABLE 1
| Grade | Number of hairs collected |
|---|---|
| I | < 10 |
| II | 10 ≤ and < 50 |
| III | 50 ≤ and < 100 |
| IV | 100 ≤ and < 150 |
| V | 150 ≤ and < 200 |
| VI | 200 ≤ and < 250 |
| VII | 250 ≤ and < 300 |
| VIII | 300 ≤ and < 400 |
| IX | 400 ≤ and < 500 |
| X | 500 ≤ |
TABLE 2
| Subject ID | Sex | Age | Factors causing telogen effluvium | Onset period (The time when hair loss symptoms began) [The number of weeks counted backward] | Hair count | Telogen hair ratio [%] | Hair wash test | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non vellus [/cm2] | Vellus [/cm2] | Terminal [/cm2] | Nonterminal [/cm2] | Total [/cm2] | Investigator | Subject | ||||||
| TR‐01 | Male | 48 | Febrile illness (COVID‐19) | Unclear (visited 16 weeks after COVID‐19) | 107.8 | 54.1 | 79.7 | 82.2 | 161.9 | 18.1 | VI | VI |
| TR‐02 | Male | 50 | Appendectomy | 16 | 167.3 | 28.1 | 142.7 | 52.7 | 195.4 | 12.1 | IV | VI |
| TR‐03 | Female | 45 | Febrile illness (COVID‐19) | 10 | 164.9 | 69.9 | 133.9 | 100.9 | 234.7 | 12.2 | VI | VI |
| TR‐04 | Female | 56 | Psychological stress | 30 | 128.0 | 50.2 | 54.6 | 123.5 | 178.1 | 5.4 | IV | IV |
| TR‐05 | Male | 36 | Psychological stress | 25 | 165.4 | 39.9 | 149.6 | 55.6 | 205.2 | 4.6 | II | II |
| TR‐06 | Female | 63 | Crash diet | 17 | 127.0 | 32.5 | 96.5 | 63.0 | 159.4 | 7.2 | VII | V |
| TR‐07 | Female | 42 | Febrile illness (COVID‐19) | 20 | 195.9 | 37.9 | 135.8 | 97.9 | 233.8 | 10.0 | III | II |
| TR‐08 | Female | 55 | Psychological stress | 12 | 191.4 | 48.7 | 126.5 | 113.7 | 240.2 | 16.3 | II | IV |
| TR‐09 | Female | 57 | Febrile illness (excluding COVID‐19) | 7 | 194.9 | 9.8 | 169.3 | 35.4 | 204.7 | 11.9 | VIII | IV |
| TR‐10 | Female | 42 | Febrile illness (COVID‐19) | 17 | 220.0 | 19.2 | 190.0 | 49.2 | 239.2 | 5.9 | V | III |
| TR‐11 | Female | 33 | Psychological stress | 8 | 108.8 | 50.2 | 86.1 | 72.8 | 159.0 | 27.8 | I | I |
| TR‐12 | Female | 45 | Febrile illness (COVID‐19) | 8 | 217.0 | 66.9 | 133.9 | 150.1 | 284.0 | 17.1 | II | II |
TABLE 3
| Subject ID | Sex | Age | Adverse event | Severity | Seriousness | Causality | Treatment of Investigational drug | Outcome |
|---|---|---|---|---|---|---|---|---|
| TR‐03 | Female | 45 | Fibula fracture | Severe | Serious | Not related | No change | Resolved |
| TR‐04 | Female | 56 | Contact dermatitis | Moderate | Nonserious | Related | Termination | Resolved |
| TR‐05 | Male | 36 | Increase in serum aspartate aminotransferase | Mild | Nonserious | Not related | No change | Resolved |
| Increase in serum C‐reactive protein level | Mild | Nonserious | Not related | No change | Resolved | |||
| Pyrexia | Mild | Nonserious | Not related | No change | Resolved | |||
| TR‐11 | Female | 33 | Glucose urine present | Mild | Nonserious | Not related | No change | Resolved |
| TR‐12 | Female | 45 | Vomiting | Mild | Nonserious | Not related | No change | Resolved |
| Abdominal pain | Mild | Nonserious | Not related | No change | Resolved |
References
- Pathologic Dynamics of Human Hair Loss: I. Telogen Effluvium Archives Of Dermatology, 1961
- Management of Hair Loss After Severe Acute Respiratory Syndrome Coronavirus 2 Infection: Insight Into the Pathophysiology With Implication for Better Management Journal of Dermatology, 2022
- Telogen Effluvium Indian Journal of Dermatology, Venereology and Leprology, 2013
- Burden of Hair Loss: Stress and the Underestimated Psychosocial Impact of Telogen Effluvium and Androgenetic Alopecia Journal of Investigative Dermatology, 2004
- Telogen Effluvium – A Review of the Science and Current Obstacles Journal of Dermatological Science, 2021
- Minoxidil: Mechanisms of Action on Hair Growth British Journal of Dermatology, 2004
- Effect of Minoxidil on Proliferation and Apoptosis in Dermal Papilla Cells of Human Hair Follicle Journal of Dermatological Science, 2004
- Untitled Fitzpatrick's Dermatology, 2019
- Hair Shedding in Women: How Much Is Too Much? British Journal of Dermatology, 2015
- Recent Advances in Understanding of the Etiopathogenesis, Diagnosis, and Management of Hair Loss Diseases Journal of Clinical Medicine, 2023
- Hair Evaluation Methods: Merits and Demerits International Journal of Trichology, 2009
- Telogen Effluvium: New Concepts and Review Archives of Dermatology, 1993
- Telogen Effluvium: A Review Journal of Clinical and Diagnostic Research, 2015
- Telogen Effluvium: A Review of the Literature Cureus, 2020
- Treatment of Chronic Telogen Effluvium With Oral Minoxidil: A Retrospective Study F1000Res, 2017
- Oral Minoxidil Use in Androgenetic Alopecia and Telogen Effluvium Archives of Dermatological Research, 2023
- Guidelines for the Diagnosis and Treatment of Male‐Pattern and Female‐Pattern Hair Loss, 2017 Version Journal of Dermatology, 2018
- Low‐Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS) With a Focus on Pericardial Effusions Journal of Cosmetic Dermatology, 2025
- Female Pattern Hair Loss: Current Treatment Concepts Clinical Interventions in Aging, 2007
Used In Evidence Reviews
Similar Papers
Annual review of nutrition · 2004
Secular trends in dietary intake in the United States.
Journal of the American Academy of Dermatology · 2002
A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men.
Journal of the American Academy of Dermatology · 2017
The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis.
Current problems in dermatology · 2015
Alopecia areata.
Drug design, development and therapy · 2019
Minoxidil and its use in hair disorders: a review.
Journal of cosmetic dermatology · 2021