27 November 2024
New consensus guidelines for oral minoxidil in hair loss
Find out what’s in the internationally developed expert consensus statement.
An international panel of hair loss experts has produced a 76-item consensus guideline regarding the use and monitoring of low dose oral minoxidil in patients with hair loss.
Although topical minoxidil was initially approved by the FDA to treat androgenetic alopecia after it was originally approved as an antihypertensive, it has become a common off-label treatment for other types of hair loss in adults as well as children.
The use of low dose oral minoxidil (LDOM) in an off label setting for various types of hair loss is growing, but there are limited data available regarding the initiation and monitoring of LDOM for hair loss.
In an effort to address the paucity of data in this space, a group of international experts have developed a 76-item consensus statement relating to off-label prescribing of LDOM in patients with hair loss, publishing their recommendations in JAMA Dermatology.
“[LDOM] has now been adopted pretty much worldwide – it’s got to the point where everybody’s using it – but it hasn’t gone through the full regulatory pathways and development programs because it’s been used off label for the treatment of hair loss, and so people are doing it differently,” said Professor Rod Sinclair, a Melbourne-based dermatologist who owns the worldwide patents on LDOM for the treatment of hair loss.
“It’s about time that we actually have international expert guidelines to fill the gap.”
Forty-three hair loss experts (a median 15 years of post-residency dermatology experience) with experience in prescribing LDOM for hair loss from 12 countries completed a four round modified Delphi process. The majority of participants practiced in academic institutions (76.7%).
The expert group started with 180 items and ended up with 76 consensus outcomes where at least 70% of participants agreeing or strongly agreeing with each item on a five-point Likert scale (ranging from “strongly disagree” to “strongly agree”).
There was a strong consensus that LDOM may be beneficial for a range of hair loss conditions, including androgenetic alopecia, age-related pattern thinning, alopecia areata, telogen effluvium, traction alopecia, endocrine alopecia and several forms of cicatricial alopecia.
The hair loss experts agreed LDOM may be preferred over the topical version of the treatment where the former is cheaper and more convenient, or when the latter is associated with undesirable residue, a change in hair texture, scalp inflammation or a less-than-ideal treatment response.
There was agreement that LDOM should not be used in patients with a history of pericardial effusion, pericarditis, congestive heart failure, pulmonary hypertension with mitral stenosis or pheochromocytoma, nor should it be used in patients who are pregnant or breastfeeding.
There was also a consensus that a history of tachycardia or other arrhythmia, hypotension or kidney function impairment should be considered precautions for LDOM use.
The authorship group, which Professor Sinclar described as “the cabal of international hair experts”, proposed that adult males should start on a daily dose of 2.5mg of minoxidil, while females should start at 1.25mg per day.
However, Professor Sinclair, who is also editor of Dermatology Republic, noted that doses in Australia typically started much lower (as low as 0.25mg per day) as these allowed clinicians a more flexible, patient-friendly approach to treatment.
“We know that you’ve really only got one trick [that works for treating hair loss]. If you give a patient high dose of minoxidil and they get a side effect, then they get spooked and they won’t take it anymore. But you’ve got no plan B, because nothing else in history has ever grown hair like this,” he said.
“So, we’re much more cognisant to start slowly and make sure patients can tolerate that initial dose. That way, if you increase the dose and they get a side effect, they’ll be happy to go back to the previous dose – and you haven’t burned your one trick.”
There was strong agreement amongst participants that spironolactone could be used as an adjunct treatment to LDOM in biologically or transgender female patients with hirsutism, acne, polycystic ovary syndrome or lower extremity or facial oedema.
Experts felt that LDOM treatment needed at least three months to demonstrate efficacy, or at least six months in patients who experience transient hair shedding after commencing LDOM.
A key limitation to the development of the consensus guidelines were an underrepresentation of paediatric hair loss experts in the final group of clinicals who participated in the Delphi process, resulting in the inability to reach a consensus regarding minoxidil use and dosing in younger patients.
The authors felt their efforts made a substantial contribution to the current understanding of how LDOM can be safely and effectively used in clinical practice.
“These consensus recommendations serve as a crucial reference for dermatologists treating patient with hair loss, offering best-practice insights into LDOM until further data emerge,” they wrote.
Professor Sinclair is hopeful that the “further data” will arrive sooner rather than later, sharing with Dermatology Republic that his phase I study of LDOM will be completed by the end of this year – and that there are plans to continue this work in 2025.
“We’re in the final stages of fundraising for the phase III trials, which we anticipate will start in February and finish within 10 months. If all goes well the licensed, approved medication could be available as soon as the middle of 2026,” he said.
