Hydrogen peroxide and the common wart: Phase 2 results are in
In a phase 2 randomized, double-blind, vehicle-controlled trial (WART-203), investigators found that an eight-week twice-weekly application of hydrogen peroxide 45% solution is a safe and effective treatment for common warts.
In the clinical trial, 157 patients (older than eight years old) had between one and six warts measuring three to eight millimeters. Study participants were treated with a twice-weekly application of hydrogen peroxide 45% or vehicle for eight weeks. Nearly 25% of patients experienced clearance of the target wart by eight weeks (2.6% with vehicle). At the 20-week follow-up, 37% of patients treated with the hydrogen peroxide solution experienced clearance (11.8% with placebo), indicating that there may be a continued response after stopping treatment at eight weeks.
DermWorld Insights and Inquiries: Granulomatous slack skin — More than one type of mimicry
My chief resident presented a case to me enamored with his clinical diagnosis of granulomatous slack skin (GSS). Although I was delighted that he considered the disorder, I explained why I thought these inguinal and submammary pink-white subtly atrophic plaques were more likely lichen sclerosus. If I have learned anything over the years, however, it’s that cutaneous T cell lymphoma (CTCL) and its variants can mimic anything. In this case, the biopsy proved me right — having been fooled so many times before, I did not gloat (admittedly, holding back the temptation). Keep reading!
FDA loosens restrictions on compounding in physician offices
In response to a multi-year advocacy effort spearheaded by the AADA Compounding Workgroup, the Food and Drug Administration (FDA) released a final rule confirming that physicians can safely prepare compounded medications in their own offices.
After increased dialogue with the FDA to explain that the drugs prepared in dermatology offices are low risk and in low volumes, the workgroup was successful in securing an exception for physicians from meeting the same onerous equipment and process requirements as large compounding facilities when conducting in-office preparations.
From the beginning
In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened the FDA’s oversight of compounding facilities and gave the FDA the green light to take steps to restrict physician in-office compounding and office-use compounding. Initially, the FDA’s interpretation of the DQSA resulted in the FDA issuing a draft guidance that threatened dermatologists’ ability to prepare drugs in the clinical setting, such as buffered lidocaine and reconstituted botulinum toxin.
[Learn more about USP and its guidelines for sterile compounding in DermWorld.]
Advocacy continues
This is a major step forward in our work, and a win for dermatologists and their patients. We still continue our state-level advocacy with the United States Pharmacopeial Convention (USP) in terms of developing a monograph for buffered lidocaine, and in relation to edits to chapter 797 since many state pharmacy boards ultimately adopt USP guidelines into their state regulations.
DermWorld Young Physician Focus: You are what you consume
We’ve all had this frustrating patient encounter: A patient (we’ll call her Karen) comes in with classic allergic contact dermatitis. You spend time asking her about recent exposures or new personal care products, and she reveals she started using a new organic cleanser with all-natural ingredients that she purchased at the farmer’s market. You take the time to prescribe a topical steroid and review safe personal care products for Karen to use. At the end of the encounter, you’re met with the dreaded blank stare, followed by, “Doctor, do you think it’s something I’m eating?” Deep breath.Read more from DermWorld Young Physician Advisor Jenna O’Neill, MD.
Deadline for MIPS extreme and uncontrollable circumstances application approaching
In response to COVID-19 being declared a global pandemic, the Centers for Medicare and Medicaid Services (CMS) has determined MIPS-eligible physicians can apply for the extreme and uncontrollable circumstances exemption.
Physicians may apply as individuals or as a group to be exempt from reporting regardless of how you submit your data (DataDerm™, EHR, etc). Those that are approved do not have to report any data for the categories selected in their application for the 2020 reporting year. This will result in there being neither a penalty or an incentive for 2022 reimbursements.
Last week, the Food and Drug Administration (FDA) released final guidance to assist industry in understanding when a microneedling product is a device and when it is not. The guidance includes information on the regulatory pathway to get microneedling devices to market for cosmetic use. Currently, the FDA defines microneedling devices as “instruments with technological features, such as many small needles, tips, or pins on the surface, which are repeatedly inserted and removed into the skin.”
Whether a product is defined as a device impacts regulatory requirements. As it relates to dermatology, below are examples of claims that would indicate a microneedling product is a device:
Treats scars
Treats wrinkles and deep facial lines
Treats cellulite and stretch marks
Treats dermatoses
Treats acne
Treats alopecia (hair loss)
Stimulates collagen production
Stimulates angiogenesis
Promotes wound healing
Generally, microneedling products that do not penetrate epidermal and dermal layers of the skin and claim only to do the following would not be devices:
Facilitate exfoliation of the skin (i.e., disruption or removal of the stratum corneum)
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