Therapeutics Focus: Hair and Nails

Biotin Supplements Cause Misleading Test Results

A new case report in the Journal of the Endocrine Society documents how a patient’s use of a biotin supplement caused her to have clinically misleading test results, which prompted numerous consultations and unnecessary radiographic and laboratory testing.

In November 2017, the FDA issued a warning “alerting the public, healthcare providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.”

Many patients take biotin supplements, which are touted to improve skin, hair, and nails, but use can produce clinically misleading test results.

The patient in the case report took a 5,000mcg dose of biotin daily. Biotin supplements in that dosage are commonly sold over-the-counter, without a prescription, in many grocery and drug stores for about $8-$20 a bottle.

In this patient’s case, “The negative clinical impact included weeks of psychological distress concerning the possibilities of hypercortisolemia or a testosterone-producing tumor. Most significantly, these abnormal test results nearly resulted in an unnecessary invasive procedure for a complex patient with a hypercoagulable state,” the case report says.

“The literature is lacking with regard to biotin interference with serum cortisol and testosterone immunoassays, as in our case-report,” says Maya Styner, MD, associate professor of endocrinology and metabolism in the department of medicine and the case report’s corresponding author. “Patients are ingesting supplements in a higher frequency, and higher doses, and therefore this case is timely and relevant from both a clinical and basic-science perspective.”

Study Evaluates Topical 2% Tofacitinib for Children with Alopecia Areata and More

Noting a lack of FDA approved treatments for children with alopecia areata (AA) and a lack of large controlled studies on medications used for alopecia totalis (AT) and alopecia universalis (AU), researchers evaluated the efficacy of topical 2% tofacitinib for children with AA, AT, and AU. Clinical trials have shown benefit from oral Janus kinase (JAK) inhibitors in adults with AA, but data regarding pediatric patients are limited to case reports, the authors note.

PRP FOR HAIR LOSS?

There is a good scientific rationale for the use of platelet rich plasma (PRP) for hair loss, and the safety profile is favorable. However, human clinical data are limited, and there is no “standard” for treatment. Terrence Keaney, MD talks to host Adam Friedman, MD about the state of the art in PRP treatment.

Watch now at dermtube.com/series/ask-an-expert

Eleven pediatric patients aged four to 16 whose alopecia had been present at least two years and who had failed treatment with three-week courses of oral prednisone or prednisolone as well as class 1 or 2 topical steroids were treated with nonpatented formulations of 2% topical tofacitinib.

The results, published in the Journal of the American Academy of Dermatology, found the average change in Severity of Alopecia Tool (SALT) score was a reduction of 32.3 percent. Eight of 11 patients demonstrated an improvement in SALT score and three had cosmetically acceptable regrowth, meaning it was sufficient to cover the scalp or able to conceal residual areas of hair loss. All patients tolerated treatment without adverse effects.

According to the study, the limited results suggest topical tofacitinib might be a reasonable adjunct or second-line therapy for pediatric patients with AA, AT, and AU for whom systemic therapies are not desired. More studies are needed.

SB208 Increases Daily Nail Growth Rate over Four Weeks of Treatment

Novan, Inc. shared data from its onychomycosis development program with SB208 gel demonstrating an enhanced nail growth rate in adult females at last month’s International Investigative Dermatology meeting in Orlando, FL.

In the Phase 1, single-center, double-blinded, randomized clinical trial in 32 adult females, Novan evaluated the rate of fingernail growth associated with SB208 16% and the local tolerability of the gel when used over the course of 29 days. The daily nail growth rate of each patient was assessed first during a 28-day run-in period with no treatment and then a 28-day period with once daily topical treatments of SB208 16% or vehicle. SB208 16% demonstrated a statistically significant greater mean daily nail growth rate for the treatment period when compared to the same patient’s own growth rate in the run-in period, as well as versus vehicle-treated patients during the treatment period. SB208 16% was well tolerated and no adverse events related to use were reported.

“Fungal infections like onychomycosis of the toenails can be difficult to treat due to slow growth of the nails,” stated Boni Elewski, MD, endowed professor for graduate education and chair; residency program director, Department of Dermatology at the University of Alabama, Birmingham. “SB208’s ability to kill the dermatophytes that cause onychomycosis and tinea pedis while accelerating nail growth via nitric oxide could provide a meaningful advancement in an otherwise year-long course of treatment for patients with onychomycosis.”

Novan previously announced positive Phase 2 clinical trial results with SB208 in patients with tinea pedis caused by the same pathogen that is prominent in onychomycosis. The company is currently exploring potential partnerships, collaborations or other strategic relationships to further advance SB208 in the US and select geographies.