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Outcomes of Treatment With Botulinum Toxin Type A With Topical Minoxidil vs Topical Minoxidil Alone in Males With Androgenetic Alopecia
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- This randomized controlled trial evaluated the efficacy of treatment with botulinum toxin type A (BTA) combined with topical 5% minoxidil in 60 males with androgenetic alopecia. Patients who received BTA and minoxidil showed significant hair growth improvement at 4 and 6 months, higher patient satisfaction, and a better quality of life compared with those who received minoxidil alone. No adverse effects were observed after treatment with BTA.
- This study suggests that combination treatment with BTA and topical 5% minoxidil significantly improves hair growth, scalp health, and quality of life in males with androgenetic alopecia.
abstract
This abstract is available on the publisher's site.
Access this abstract nowAndrogenetic alopecia (AGA) is a common type of hair loss in men and efficacy and safety of current medical treatment remain limited. Therefore, the present study aimed to investigate the efficacy and safety of botulinum toxin type A (BTA) combined with Minoxidil in patients with AGA. 60 male patients were included in this study and control group received topical 5% Minoxidil and the treatment group received BTA combined with topical 5% Minoxidil. BTA injections (60-70 U) were administered at 30-35 scalp sites. Head photographs were taken at baseline, 2nd, 4th, and 6th months. Clinical descriptions recorded scalp conditions, and patient satisfaction along with Dermatology Life Quality Index scores were documented. The treatment group (TG) showed significant hair growth differences compared to the control group (CG) at the 4th month (P < 0.001) and 6th month (P = 0.0046) post-treatment. TG had improved Investigator Global Assessment (IGA) scores in the 4th month (P = 0.0001) and 6th month (P = 0.0259) compared to CG. Patient satisfaction in TG for hair growth and scalp improvement was higher than CG (all P < 0.05). TG exhibited substantial quality of life improvement at the 4-month (P = 0.0009) and 6-month (P = 0.0099). No adverse reactions were observed post-botulinum toxin injection. BTA combined with Minoxidil effectively promotes hair growth, enhances the quality of life, and alleviates scalp symptoms in male AGA patients at 4th and 6th months, with no adverse effects compared to Minoxidil alone.Trial registration number: Ethics Committee of Shanghai Tongji Hospital (ID: K-2018-026).
Additional Info
Assessing the efficacy and quality of Life improvements of botulinum toxin type a with topical minoxidil versus topical minoxidil in male androgenetic alopecia: a randomized controlled trial
Arch Dermatol Res 2024 Aug 17;316(8)532, L Yu, S Moorthy, X Li, L Peng, Z Zhang, L Shen, Y Han, X HuangFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
The aim of this study was to assess the efficacy of adding botulinum toxin injection therapy to topical minoxidil versus topical minoxidil alone in the management of patients with androgenetic alopecia. Although this publication from our colleagues in Shanghai appears to offer sound and statistically significant conclusions, I would urge caution to the reader.
Numerous publications have demonstrated a lack of, or possibly only marginal, efficacy of the use of botulinum toxin injections for the improvement of androgenetic alopecia. Other publications that were either unblinded or open-label studies have shown some efficacy. The current study randomized 60 men with androgenetic alopecia to either the treatment group (n = 30), which received topical minoxidil along with adjunct botulinum toxin injections, or the control group (n = 30), which received topical minoxidil alone. The assessments were reportedly performed by 3 blinded dermatologists, and they recorded dramatic improvements at 4 and 6 months in terms of the quality of life (the Dermatology Life Quality Index), symptomatic control, and hair regrowth in the treatment group compared with the control group.
Given the small sample size of the study, it seems suspicious that such power and statistical significance could be achieved unless there was profound hair regrowth — unlike that which has ever been previously reported. Therefore, I am reluctant to accept the results. Certainly, with regard to the assessments provided by the patients as patient-reported outcomes (ie, the Dermatology Life Quality Index and symptomatology), the patients were clearly aware of the aims and design of the study, and they were obviously aware of whether they received injections or not (thus, non-blinded). This non-blinding makes the patient-reported outcomes invalid, as they are critically vulnerable to subject bias. Moreover, in virtually every case of androgenetic alopecia that I have encountered, there have never been any symptoms (other than mental/emotional) unless accompanied by any of the various dermatitides, such as seborrheic dermatitis. Finally, it seems odd to me that no adverse events were reported in 60 men applying topical minoxidil to the scalp, given that the rate of adverse events, namely pruritus, scalp irritation, dizziness, and contact allergy, is reported to be at least 5% to 7%.