PracticalDermatology

When most Americans, including physicians, think about wipes these days, the first thing that comes to mind are disinfecting surface cleansing wipes. But dermatologists are well aware that pre-moistened wipes are widely used in the cosmetics, beauty, and self-care industries. Here, too, the majority of use is for cleansing. However, medical dermatology has seen the development of prescription medicated wipes in the form of Qbrexza (glycopyrronium, Dermira).

Pre-medicated wipes represent a potentially convenient, cost-effective, and precise delivery option for a variety of topical medications, and dermatologists should anticipate new products coming to market. Ahead, I’ll review the science of premoistened wipes and explore potential applications for dermatology patient care.

Wipes and Unit Dose Packets

Unit dose packets are attractive to the pharmaceutical industry and patient/consumers due to their hygienic, compliance, and portability advantages. Potential disadvantages include limitations in terms of stability of some molecules as well as potential contamination if wipes are improperly re-used. Generally, any molecule that is soluble and can be made into a free forming liquid lends itself very easily to formulation in a wipe. Depending on the stability and compatibility of the intended components, wipes may be formulated to deliver two or more active drugs in combination.

Whereas lotions, gels, creams, foams, and ointments may have variable levels of patient acceptance or ease of application and use, depending on the site of application—think of applying ointment to hairy skin—wipes have a very wide potential for application. There is sometimes concern about drug transfer (whether of drug to other body sites or of greasy ointment bases onto clothing). By washing your hands immediately after use or by simply wearing gloves, the user can precisely apply quick-drying medication with a wipe with minimal risk for transfer. This is, in fact, the mode of application for Qbrexza.

Ninety percent of wet wipes on the market are produced from nonwoven fabrics made of polyester or polypropylene.¹ These nonwoven sheets come in a variety of strengths and textures. Therefore, it may be possible to match specific textures to certain disease states. For example, a wipe with texture may be favorable if light exfoliation of the face is desired.

Additionally, there is significant variety in the supportive ingredients that may be formulated with a medicated wipe. Moisturizing, humectant, and emollient ingredients can potentially be incorporated into wipes to enhance tolerability and support skin health and function.

From a pharmaceutical perspective, an especially attractive feature of single-dose wipes is that they allow companies to bring to market patent-protected delivery forms of their already-approved molecules. The FDA has been advocating technologies that better enable generic manufacturers to measure bioequivalence against the established or innovator drug. This creates pressure on the branded manufacturers to create patent exclusivity and incentivizes those manufacturers to develop their existing topical medicines in different delivery forms that can be patented and acquire FDA exclusivity. Through the 505(b)(2) process at FDA, manufacturers who wish to bring a drug to market in a different delivery format can reference all the safety and efficacy data on the approved label for an alternative delivery method.

The Case of Qbrexza

The first FDA approved single-use prescription towelette, Qbrexza received FDA approval in June 2018 for treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older.²

Applying the medication topically rather than systemically is thought to reduce the incidence of anticholinergic side effects, such as dry mouth, muscle cramps, and urinary retention.³

After four weeks, patients using Qbrexza experienced a 25 to 30 percent reduction in sweating severity. The volume of underarm sweat was also reduced by 50 percent or more in most patients.

It is reasonable to anticipate that Qbrexza represents just the first in a variety of dermatologic therapies that will be brought to market in the unit-dose, wet wipe form. The unit-dose towelette may prove beneficial for the application of any topical drug that, like glycopyrronium, has the potential for significant adverse events if absorbed systemically. Topical drugs in development with significant potential for systemic adverse events include topical JAK inhibtors. Incyte (ruxolitinib and tofacitinib) alone and in partnership with Lilly (baricitinib), Pfizer (abrocitinib), and AbbVie (upadacitinib) all have topical JAK inhibitors in development.

Looking Ahead

In the OTC space, there has been discussion of providing sunscreens via wipes or towelettes, however, this dosage form is not considered GRASE under the current monograph. Any wipe or towelette formulation of sunscreen would have to come to market following FDA review as a new dosage form. ⁴ The ability to deliver mineral sunscreens via towelettes may be particularly attractive in the current marketplace.

Benzoyl peroxide may be the dermatology drug best known as having been offered via wipe applicators both by prescription and in the OTC space. These pads are often provided in canisters rather than unit-dose packs. The availability of single-dose pack wipes would be expected to provide greater patient convenience and sterility, compared to moistened pads provided in a jar or canister.

Clindamycin has been provided on the prescription (branded and generic) market as pledgets for some time. Pledgets are commonly referred to as “pads in a jar.” As in the case of benzoyl peroxide, the availability of unit-dose packs of clindamycin would improve sterility and convenience.

Conceivably, other topical antibacterials could be provided in towelettes; and a larger size pad with applicator could be particularly well-suited to treatment of acne on the chest and back.

Pre-moistened applicators have also been available on the market containing sodium sulfacetamide 10% and sulfur 4% for acne. Lidocaine-containing wipes are also widely available.

Another potential application of single-dose pack pre-moistened towelettes may be for the delivery of 5-fluorouracil for the treatment of AKs. Additionally antifungals, especially when prescribed for treatment of infections in the intertriginous areas, could conceivably be delivered via towelettes. The ability to wipe on the medication and dispose of the pad would reduce the risk for cross-contamination on the body or contamination of the dispenser. Note that many antifungals are currently dispensed as creams or ointments. The lighter solution delivered via towlette may have enhanced tolerability and acceptance for the axilla and groin.

Significant Potential

The potential to prescribe dermatologic drugs in unit-dose, towelette form is significant. Think of the most commonly cited reasons for patient non-adherence, and consider how a wet-wipe pack could counter these. Our patients are increasingly “on the go,” and even when many have transitioned to work from home, most Americans today find themselves juggling multiple professional, family, and personal demands. Keeping up with medications often falls off if patients perceive the regimen as inconvenient or the medication itself to be unacceptable. It is easy to put a packet in your purse or pocket, reducing missed applications. Wipes are TSA compliant and ideal for travel. As opposed to a large tube or tub, wipes are hygienic (one reason they are so popular in hospitals and longterm care settings).

In fact, surveys show that two out of three patients prefer pre-moistened applicators (e.g., wipes, swabs, pads) vs. traditional creams, lotions, ointments, or gels for the topical application of prescription drugs.⁵ It is also worth noting that newer biodegradable wet wipes are more eco-friendly, capable of being recycled or flushed down the toilet without contributing to sewer blockages or environmental waste.⁶

1. http://www.madehow.com/Volume-6/Baby-Wipes.html

2. https://www.dermatologytimes.com/view/spotlight-dermira-and-qbrexza-story

3. https://www.sweathelp.org/hyperhidrosis-treatments/qbrexza.html

4. https://www.fda.gov/news-events/press-announcements/fda-advances-new-proposed-regulation-make-sure-sunscreens-are-safe-and-effective

5. AYTM Market Research; Internet Survey; N=300; February 12th 2020

6. https://stylecaster.com/beauty/best-biodegradable-wet-wipes/

7. https://en.wikipedia.org/wiki/Wet_wipe

8. https://www.grandviewresearch.com/industry-analysis/personal-wipes-market

9. https://www.technavio.com/report/wet-tissue-and-wipe-market-industry-analysis

10. https://www.ptcommunity.com/wire/healthcare-wipes-grow-38-annually-through-2023