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Oral Minoxidil For Alopecia Not Affected By Concurrent Antagonistic Medications

The efficacy of low-dose oral minoxidil for the treatment of alopecia may not be affected by the concomitant use of mechanistically antagonistic medications, according to a retrospective study.

Changes in median trichometric width and density were 5.5 μm and 18.5 hairs/cm2 for those concurrently using antagonistic medications, such as non-steroidal anti-inflammatory drugs (NSAIDs) and stimulants, and 2.0 μm and 22.0 hairs/cm2 for those not using antagonistic medications, reported Kristen Lo Sicco, MD, of the NYU Grossman School of Medicine in New York City, and colleagues.

There was no significant difference in the change of trichometric width (P=0.337) or density (P=0.229) between cohorts, they wrote in a research letter in JAAD International.

"Providers should encourage patients to adhere to their concurrent medications without fear of impeding progress in their hair growth journey," the authors concluded.

At higher doses, oral minoxidil is approved by the FDA for hypertension. "When administered at low doses for alopecia, it is currently presumed to augment microcirculation surrounding the hair follicle, stimulating hair growth, with minimal blood pressure impacts," Lo Sicco and team noted. Topical minoxidil (Rogaine) is approved by the FDA for androgenetic alopecia in men and women.

"Low-dose oral minoxidil has become a widely used therapy to promote hair growth and thickening in patients with alopecia," Kathie Huang, MD, of Brigham and Women's Hospital in Boston, told MedPage Today. "It acts on potassium channels in vascular smooth muscles, leading to vasodilation around hair follicles. This mechanism, among other potential effects, is thought to contribute to increased hair growth."

Lo Sicco and colleagues noted that "alopecia patients frequently present with comorbid conditions, necessitating careful consideration when formulating treatment plans. This is particularly true when utilizing LDOM [low-dose oral minoxidil] for the treatment of androgenetic alopecia, as patients typically present in the third or fourth decade of life with a higher likelihood of concomitant medication use to manage comorbidities."

"Our findings underscore that LDOM remains effective in treating alopecia, even in medically complex patients with multi-drug regimens involving antagonistic medications," they added.

The antagonistic medications being used among this study population included formoterol (11%), NSAIDs (32%), stimulants (32%), tricyclic antidepressants (21%), triptans (16%), and oral steroids (5%).

The study was conducted from January 2009 through August 2023 and included 71 patients. Mean age was 37.3 years, and 60.6% were women. Most (91.5%) had been diagnosed with non-scarring alopecia.

Alopecia subtypes included androgenetic alopecia (71.8%), telogen effluvium and frontal fibrosing alopecia (2.8% each), androgenetic alopecia plus telogen effluvium (16.9%), and androgenetic alopecia plus lichen planopilaris (5.6%).

Side effects were reported by 23 patients, including hypertrichosis (22.5%), dizziness (4.2%), headache (4.2%), and fluid retention/edema (1.4%). There were no significant differences in incidence of side effects between the cohorts (P=0.27).

"Although low-dose oral minoxidil is often well-tolerated in patients with alopecia, potential side effects exist," Huang cautioned. "Special consideration must be given when starting oral minoxidil in patients with cardiac medical diagnoses, edema, low blood pressure, or those on cardiac medications."

"Patients may initially experience shedding and increased facial hair, so it is important to counsel them about these common potential side effects," she added. "Patients should also avoid the medication during pregnancy."

Limitations acknowledged by Lo Sicco and team included the study's retrospective design, small sample size, use of patient-reported side effects, and lack of recorded changes in blood pressure, which they noted were nonsignificant in early research.

Kate Kneisel is a freelance medical journalist based in Belleville, Ontario.

Disclosures

The study authors reported no conflicts of interest.

Huang reported consulting for Concert Pharmaceuticals and Pfizer; participating in clinical trials related to alopecia from Aclaris, Concert, Incyte, and Lilly; and receiving royalties for licensing of the ALTO, BETA, and BELA tools.

Primary Source

JAAD International

Source Reference: Desai D, et al "Navigating treatment challenges: assessing the influence of medications with antagonistic effects on low-dose oral minoxidil in patients with alopecia: a retrospective study" JAAD Int 2024; DOI: 10.1016/j.Jdin.2024.05.010.

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FDA Approves Deuruxolitinib For Alopecia Areata

The FDA has approved deuruxolitinib, an oral medication developed by Sun Pharma, as the first-line treatment for adults with moderate to severe alopecia areata.

The FDA approved deuruxolitinib as a first-line treatment method for adults with moderate to severe alopecia areata.Image Credit: Surendra - stock.Adobe.Com

The FDA has approved deuruxolitinib as a first-line treatment for adults with moderate to severe alopecia areata (AA).1

Deuruxolitinib, developed by Sun Pharma, is an oral selective inhibitor of Janus kinases JAK1 and JAK2, typically dosed at 8 mg twice daily. Currently, AA does not have a cure and relies heavily on the limited treatment options available to reduce symptoms and stimulate hair regrowth.

"Deuruxolitinib is an important addition to the AA treatment toolbox. With each new medicine approved for AA, more patients will be successfully treated. It's amazing how far we have come in so short a time," commented Brett King, MD, PhD, associate professor of dermatology at Yale Medicine.

The standard of care for adult patients with AA is the oral selective JAK inhibitor, baricitinib.2 Other forms of treatment include corticosteroids, topical immunotherapy, cyclosporine A, methotrexate, and azathioprine.

Abhay Gandhi, CEO-North America, Sun Pharma, stated, "We believe that deuruxolitinib has the potential to be an important new treatment option for people who continue to struggle every day with the chronic nature of alopecia areata."1

The approval is supported by the THRIVE-AA1 (NCT04518995) and THRIVE-AA2 trials (NCT04797650), randomized, double-blind, placebo-controlled clinical trials presented at the 2024 American Academy of Dermatology Annual Meeting.3 These analyses included adults aged 18 to 65 years with moderate to severe AA located in the US, Canada, and Europe.1

Patients were randomized to receive either 8 mg twice daily, 12 mg twice daily, or a placebo over the course of 24 weeks. At baseline, patients had average Severity of Alopecia Tool (SALT) scores of 85.9 and 87.9 of 100 for THRIVE-AA1 and THRIVE-AA2, respectively.

The THRIVE-AA1 trial looked for key efficacy outcomes among patients with AA.4 Results from this trial declared the twice-dailky 8-mg and 12-mg doses of deuruxolitinib met the primary efficacy end point, a SALT score of 20 or less by week 24. As early as 8 weeks, significant hair regrowth of scalp hair began, and this continued throughout the study. The deuruxolitinib 12-mg twice0-a-day dose was found to be superior to the 8 mg dose.

In THRIVE-AA2, the primary outcome was the safety of deuruxolitinib in patients with AA.5 Both the 8-mg and 12-mg twice-daily doses were well tolerated. More than 95% of treatment emergent adverse events (TEAEs) were mild to moderate in severity; there were no serious TEAEs in the study. Minimal cases of AEs consisted of serious infections, appendicitis, COVID-19, and meningitis; discontinuation due to TEAEs was not common; and herpes zoster was considered rare. There were no thromboembolic events (deep vein thrombosis/pulmonary embolism/) or patient deaths.

Arash Mostaghimi, MD, MPA, MPH, assistant professor of dermatology, director of the inpatient dermatology consult service, and co-director of the Complex Medical Dermatology Fellowship at Brigham & Women's Hospital spoke with The American Journal of Managed Care® regarding his involvement in the THRIVE trials.

He noted, "I enrolled patients in both of these studies, and the takeaway from the overall studies is that we have another efficacious treatment for people with moderate to severe alopecia areata. Patients demonstrated scalp hair regrowth and eyebrow and eyelash regrowth, and concurrent improvement in psychosocial outcomes."

When Mostaghimi was asked how the THRIVE trials might inform future research directions for AA treatment, he stated, "The focus of the THRIVE trials on quantitative eyebrow and eyelash growth add another dimension that in correlation with patient-reported and other clinical reported outcomes gives us another perspective on a critical area of interest for patients who have severe hair loss. But the best news is to have an additional choice, because having only 2 options is limiting and the more options we have, I think the better patients will do."

The newly approved deuruxolitinib is significant for adult patients with moderate to severe AA because this inflammatory disorder does not have a cure and relies heavily on various treatments to reduce symptoms.

Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF) commented, "Alopecia areata is a chronic autoimmune disease with psychological and emotional effects, and there is still significant unmet medical need in the community. We are excited that the FDA is elevating another potential treatment option for this serious medical condition."1

References

1. Sun Pharma announces US FDA filing acceptance of new drug application (NDA) for deuruxolitinib. News release. Sun Pharma. October 6, 2023. Accessed July 16, 2024. Https://sunpharma.Com/wp-content/uploads/2023/10/Sun-Pharma-Announces-US-FDA-Filing-Acceptance-for-Deuruxolitnib.Pdf

2. Santoro C. Review finds JAK inhibitors more effective for moderate to severe AA compared with established therapies. AJMC®. March 13, 2024. Accessed July 16, 2024. Https://www.Ajmc.Com/view/review-finds-jak-inhibitors-more-effective-for-moderate-to-severe-aa-compared-with-established-therapies

3. Santoro C. Deuruxolitinib demonstrates efficacy, tolerability in patients with moderate to severe AA. AJMC®. March 14, 2024. Accessed July 16, 2024. Https://www.Ajmc.Com/view/deuruxolitinib-demonstrates-efficacy-tolerability-in-patients-with-moderate-to-severe-aa

4. Senna MM, King B, Mesinkovska AN, Mostaghimi A, Hamilton C, Cassella J. Efficacy of the oral JAK1/JAK2 inhibitor deuruxolitinib in adult patients with moderate to severe alopecia areata: pooled results from the multinational double-blind, placebo-controlled THRIVE-AA1 and THIVE-AA2 phase 3 trials. Presented at: AAD Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 51840.

5. King B, Senna MM, Mesinkovska AN, Mostaghimi A, Hamilton C, Cassella J. Pooled safety assessments from the multinational phase 3 THRIVE-AA1 and THRIVE-AA2 trials of deuruxolitinib in adult patients with moderate to severe alopecia areata. Presented at: AAD Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 54022.

Breakthrough Treatment: Topical Metformin Restores Hair In Severe Alopecia As Per New Case Study

Portugal: Central Centrifugal Cicatricial Alopecia (CCCA) presents a challenging condition for dermatologists, often resulting in permanent hair loss among individuals of African descent. Recent studies have explored novel treatments, including topical metformin, demonstrating promising results in halting disease progression and stimulating hair regrowth.

A recent case report published in the International Journal of Dermatology implied that topical metformin 10% compounded cream might be a safe and effective adjunct therapy for patients with CCCA.

A 54-year-old African woman with a history of hypertension was presented to the outpatient department due to significant hair loss affecting the central area of her scalp for the past three years. On examination, alopecia was noted in the vertex region with a negative traction test. Trichoscopy revealed marked perifollicular scaling and whitish-gray perifollicular halos.

Histopathological examination showed concentric laminated fibrosis around pilosebaceous units with sebaceous gland atrophy and moderate lymphocytic inflammatory infiltrate in the dermis, consistent with a diagnosis of central centrifugal cicatricial alopecia in phase 3b. Initially, the patient declined treatment with intralesional corticosteroids and received minoxidil 5% lotion and topical clobetasol 0.05% twice daily, with no improvement after 14 months. Subsequently, the doctors discontinued the topical clobetasol ointment and initiated the once-daily application of topical metformin 10% cream in combination with minoxidil 5% lotion twice daily.

After eight months of treatment, substantial hair regrowth was observed in the vertex region, with new repopulated areas and terminal hair follicles.

"This case report presents findings from a 54-year-old African woman diagnosed with advanced-stage central centrifugal cicatricial alopecia (CCCA), confirmed by histopathology, who experienced persistent hair loss despite initial treatment with topical corticosteroids and minoxidil. Following eight months of daily use of compounded topical metformin 10% cream alongside minoxidil 5% lotion, significant hair regrowth was observed in the vertex area, with no reported adverse effects," Bárbara Vieira Granja, Department of Dermatology and Venereology, Unidade Local de Saúde São João, Porto, Portugal, and colleagues wrote.

"This case report also highlights data from two African American females with advanced-stage central centrifugal cicatricial alopecia who also experienced visible hair regrowth with topical metformin 10% compounded cream."

"The case report underscores the transformative potential of topical metformin 10% cream in managing CCCA, offering hope to patients grappling with this challenging condition. With ongoing research and clinical advancements, dermatologists remain optimistic about refining treatment strategies and improving outcomes for individuals affected by CCCA worldwide," they concluded.

Reference:

Granja BV, De Matos PR, Rosa GP, Pinheiro J, Azevedo F, Pedrosa AF. Treatment of central centrifugal cicatricial alopecia with topical metformin 10% cream: case report and literature review. Int J Dermatol. 2024 Jun 23. Doi: 10.1111/ijd.17345. Epub ahead of print. PMID: 38923417.

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