When prescribing low-dose oral minoxidil for hair disorders in adults and adolescents, dermatologists have been able to fall back on expert-written consensus statements to guide their treatment. But they had no such resource when treating children younger than 12 years, so a group of international experts collaborated to develop a consensus for treatment in children aged 4-12 years.

The statement, published in JAMA Dermatology, outlines a six-step protocol for prescribing low-dose oral minoxidil that includes four indications — hair follicle miniaturization, hair cycle disorders, hair shaft disorders, and adjunctive therapy for selected scarring alopecias — and the contraindications, such as pheochromocytoma or a history of pericardial effusion or tamponade.

“This consensus statement should be viewed as a starting point rather than an endpoint,” lead author Yagiz Matthew Akiska, MD, MPH, dermatology resident at the University of Maryland School of Medicine in Baltimore, told Medscape Medical News. “Clinical practice has moved ahead of the prospective pediatric evidence, and consensus can help clinicians navigate that gap responsibly, but we still need prospective studies to better define efficacy, optimal dosing, long-term safety, and outcomes across specific hair disorders.”

The timing of the publication “reflects the investigators’ recognition of a significant pediatric research gap,” said Luis Fernando Sánchez-Espino, MD, pediatric dermatologist at Stollery Children’s Hospital and assistant professor at the University of Alberta in Edmonton, Canada, who was not affiliated with the consensus panel. “It represents a timely effort to increase awareness, standardize a nuanced area of practice, and establish critically appraised, expert-driven recommendations that mirror real-world clinical needs.”

Panel Structure and Guidance

The panel structure followed a modified Delphi process that used three rounds of surveys among participants to reach a consensus on key points. Fifty experts completed the first two rounds and 49 completed the third round. The process also garnered input from other disciplines, including pediatric medicine, pediatric ophthalmology and cardiology, and nephrology, as well as a caregiver advocate.

The indications for hair follicle miniaturization and hair cycle abnormalities achieved a 100% consensus, with adjunctive therapy at 98%, and hair shaft abnormalities at 84%.

The panel also posted guidance on 12 precautions for low-dose oral minoxidil use, ranging from 74% vs 92% for interactions with other drugs vs hypotension.

Akiska noted that 96% of participants agreed that low-dose oral minoxidil is safe for children in the target age group, and that “strong” consensus supports the indications.

“We do not view oral and topical minoxidil as an either/or choice for every patient,” he said. “Instead, the consensus identifies specific clinical and practical circumstances in which oral therapy may be preferable.”

Those circumstances include diffuse hair loss where topical application over a large area may be impractical or where it may be difficult to apply topical medicine in younger children. Other considerations include sensory or tactile sensitivities to topical drugs, residue or hair texture changes that may make them undesirable, or scalp inflammation that may make them intolerable. Another factor the consensus considers is caregiver preference after shared decision-making, as well as potential topical minoxidil toxicity to household pets.

“The broader message is that the route of administration can be individualized,” Akiska said. “Low-dose oral minoxidil offers another option when topical treatment creates barriers to adherence or tolerability, but the decision should still be based on the patient’s diagnosis, medical history, risk profile, and family preferences.”

The consensus also offers “practical” dosing guidance, he added. “Both fixed tablet-based and weight-based approaches reached consensus, providing flexibility according to patient needs and local formulation availability, with reassessment and dose adjustment based on response and tolerability.”

The risk-stratified approach to safety and monitoring in these younger patients that the consensus spells out is also noteworthy, Akiska said.

“The panel did not support a one-size-fits-all requirement for extensive baseline testing or repeated blood-pressure monitoring in every otherwise low-risk child,” he said. “Instead, the child’s medical history, blood pressure, medications, and cardiovascular, renal, and hepatic history should guide whether additional testing or specialist consultation is warranted.”

The goal of the consensus was to address the omission of younger patients from the 2024 consensus statement on the use of low-dose oral minoxidil for hair loss, said Akiska, who was also the lead author of that paper, published in JAMA Dermatology. “Clinicians with substantial experience treating younger pediatric patients were not well represented in that effort,” he said. “This study was therefore a natural next step.”

But the panel did not reach a consensus for use in children younger than 4 years, he said, “reflecting limited clinical experience and concerns about developmental pharmacokinetic differences that may affect systemic exposure.”

Limits of Consensus

The consensus is not an evidence-based guideline, Akiska emphasized. “The pediatric literature on low-dose oral minoxidil consists largely of retrospective studies, case series and clinical experience, and we still lack randomized trials establishing efficacy or long-term safety in children younger than 12,” he said. “So, I would view the statement as providing a rigorous framework for decision-making where higher-level pediatric evidence is currently lacking rather than as establishing efficacy.”

Sánchez-Espino credited the consensus study with using a methodology “that aligns with high research standards.” He added that the panel clearly outlined the limitations of its recommendations.

“This study not only reinforces the broad-spectrum utility of low-dose oral minoxidil for various pediatric hair disorders but also addresses real-world nuances where systemic therapy is preferred over topical treatment,” Sánchez-Espino said. Those nuances include cost-effectiveness, adherence, the logistics of topical drug application, and sensory or tactile sensitivities that children may have.

The input from other specialties and the caregiver advocate was “invaluable,” he said. “This multispecialty perspective strengthened the overall quality of the consensus, particularly regarding the discussion and monitoring of adverse events, such as potential retinal or choroidal complications in the pediatric population.”

The study received funding from the National Alopecia Areata Foundation. Akiska and Sánchez-Espino reported having no relevant conflicts of interest.

Richard Mark Kirkner is a medical journalist based in the Philadelphia area.