Relief From Ingrown Toenail

Joshua J. Pray, Pharm.D. Candidate, W. Steven Pray, Ph.D., R.Ph.


At least 10% of Americans complain of some type of foot problem, leading to approximately 17 million physician visits yearly. Ingrown toenail, known medically as onychocryptosis, is the proximate cause of 20% of those physician visits.[1] While many patients choose to visit a physician for ingrown toenail, foot problems are the specialized domain of podiatrists, who possess an advanced degree designed for problems of the feet. In an average year, the typical podiatrist sees many more cases of ingrown toenail than do most physicians, and pharmacists should take this fact into account when referring patients for professional care.

The healthy toe has a margin of about 1 millimeter between the lateral nail plate and nail fold.[2] Ingrown toenails develop when the hard side of the toenail pushes with excessive force into the relatively soft nail fold adjacent to it. This action may result from shoes that force the toes to be smashed together or from improper toenail trimming. The force of the growing toenail causes surrounding skin to become irritated and inflamed (Figure 1). If pressure is not relieved, the skin develops overt hyperplasia and hypertrophy. This narrows or obliterates the normal 1-millimeter margin, increasing the risk of skin penetration by the nail.

The force of the growing toenail can cause surrounding skin to become irritated and inflamed. If pressure is not relieved, the risk of the nail penetrating the skin is high.

While such problems as improper toenail-cutting techniques, poor foot hygiene and improper footgear are said to be causal or contributory, some authors assert that patients with this problem have an underlying congenital predisposition due to abnormally thick toenails or abnormally thin nail margins.[2] In addition, ingrown toenail frequently recurs.[3]

Ingrown toenails affect males more than females prior to age 30, in a 2:1 to 3:1 ratio.[2,4] After age 30, both genders are equally affected.

Ingrown toenail can be divided into three stages.[2] In the first stage, the patient has only erythema and swelling along the nailfold. In stage 2, the patient experiences increased pain and there is visible infection, characterized by drainage from the area. Stage 3 is associated with chronic infections, the development of granulation tissue, and soft tissue hypertrophy.

Various medical practitioners have advanced conservative methods of treating ingrown toenails, especially in cases designated at Stage 1. A conservative approach includes treating existing infections with antibacterial soaks, using oral antibiotics, and initiating various minor interventions (eg, rest, elevation, warm soaks).[2]

Recommended antibacterial soaks include diluted Burow's solution or potassium permanganate.[5] Oral antibiotics (eg, erythromycin, cephalexin) are only recommended when the patient has cellulitis or pus exuding from the lateral nail fold.[2,5]

Several references advise methods of temporarily relieving pressure on the nail fold by lifting the edge of the nail.[4,5] If the nail can be elevated from the lateral nail fold, the patient is directed to pack cotton or wool soaked in 60% alcohol beneath the nail to keep it elevated. The patient is instructed to change the cotton packing daily, reinserting as much material as necessary to ensure proper elevation. Proponents assert that this technique allows the nail to grow to a length that prevents recurrence if the patient continues the practice for approximately 7-14 days. The patient, podiatrist or physician may also pre-thin the nail (described below) to enhance its flexibility prior to packing with cotton. Some podiatrists and physicians modify this technique slightly by inserting a polyethylene tube in the groove. This modified method is known as the "gutter technique."[4]

Some podiatrists/physicians offer unusual conservative treatments, typically accompanied by anecdotal reports of high success rates.[6,7] In one such report, an Australian physician presented an economical and painless method which he said failed only once in a series of several hundred patients.[8] He suggested using a scalpel with a round blade to gently and gradually remove a part of the toenail. The targeted area is a strip perhaps 1/4 inch wide (on the great toe), extending from the outer end of the toenail down to the cuticle. The nail is to be pared carefully until the targeted area is "weak and floppy along its entire central extent." The author hypothesizes that making this nail portion flexible prevents the nail from pressing into the adjacent skin.

It is common for a small nail section known as a spicule to remain in the skin after most of an ingrown toenail has been removed. The spicule serves as a nidus for continuing, unremitting infection (Stage 2).[5] In this instance, the patient should be referred to a podiatrist or physician, so that the spicule can be located and removed using a local anesthetic. Spicules are common in patients who unwisely prefer to remove their ingrown toenails at home, using scissors and other, various nonsterile implements.

Some patients cannot elevate the nail to insert cotton because chronic infection has allowed epidermal tissue to cover the nail fold (Stage 3).[5] A professional may need to excise this tissue to facilitate elevation.

Surgical procedures for ingrown toenail are mostly reserved for Stages 2 and 3. They include removal of the growing border of the nail plate, reduction of the hypertrophied skin, and removal of all or part of the nail plate using surgery, chemicals, or lasers.

At one time, products claiming to relieve ingrown toenail were marketed with optimistic names that implied that they could actually "outgrow" an ingrown toenail. However, in a 1993 rule, the FDA stated that there was no product recognized as safe and effective for ingrown toenail.[9] It specifically pointed to tannic acid as lacking proof of efficacy. The agency also discussed a study submitted in support of sodium sulfide 1% for the temporary relief of pain associated with ingrown toenails. The submission discussed a well-designed, multicenter study in which 61 subjects with ingrown toenail were treated with either placebo or 1% sodium sulfide for 7 days. The study demonstrated clear efficacy for the active ingredient, with subjects reporting a decrease in pain beginning on the second day. The product softened the nails, a proposed explanation for its analgesic efficacy. However, the FDA also noted that many patients experienced adverse effects that forced them to voluntarily discontinue the treatment. Reactions included erosions that did not heal, tingling, stinging, slight/ severe burning, and erythema. The agency expressed concern that the high number of patients experiencing adverse reactions (16 out of 29 subjects) would not warrant nonprescription status and they denied the petition. Since 1993, there have been few nonprescription products targeted for ingrown toenail. One contained only benzocaine, which was not proven effective for the problem. Another was a box of "ingrown toenail relief strips" designed to help separate the toenail from the skin.

The status quo changed on October 4, 2002, with the publication of a proposed rule in the Federal Register.[10] In this document, the agency stated that a manufacturer (Schering-Plough) had conducted an additional well-designed safety study on sodium sulfide nonhydrate 1% in a gel vehicle. The study enrolled 157 patients over the age of 18 with painful ingrown toenail. In this study, the incidence of adverse effects for the active ingredient was comparable to that of the placebo. Apparently, the reduction in adverse effects was due to the novel application method devised by the sponsor. It was described as a retainer ring (adhesive-backed) which facilitated application to the affected area while also keeping the medication in contact with the toe. The manufacturer asked to market the product upon publication in the Federal Register, and the FDA agreed that it may do so, although any future adverse developments might cause it to be subject to regulatory action.

FDA-approved labeling for the product (the trade name was unknown at the time of publication) included directions to wash the affected area and dry thoroughly, then place the retainer ring on the toe with the slot over the area where the ingrown toenail and skin meet. The ring is smoothed down firmly. A bandage strip in the package is applied so that its round center section is directly over the gel-filled ring, sealing the gel in place. The edges of the bandage strip are to be smoothed around the toes. The patient repeats application twice daily (morning and night) for up to seven days until discomfort is relieved or until the nail can be easily lifted out of the nail groove and trimmed.

The product is for external use only. It is not to be used on open sores, and must not be used without physician approval if the patient has diabetes, poor circulation, or gout. It is used only with the retainer ring and is discontinued if the patient notices increased redness or swelling of the toe, if discharge is present around the nail, or if symptoms last more than seven days or clear up but recur within a few days.