Life just ain’t fair. Imagine surviving those self-conscious adolescent years only to later be ambushed by acne rosacea, an embarrassing form of adult acne.
Now, though, there’s new hope: Metronidazole, a drug long dispensed in oral (or injectable) form, could provide an effective topical treatment for this aggravating ailment.
Rosacea, which is a bit more common in women than in men, often makes its debut when a patient is in his or her 30s. The face, dotted by papules and pustules, grows progressively redder, noted John Presutti, v.p. -sales and marketing, Curatek Pharmaceuticals Inc. Small blood vessels dilate and become visible. The nose can become bulbous, the eyes inflamed. Dryness and itching may be accompanied by localized tenderness.
Comedian W C. Fields did beleaguered patients a disservice, Presutti noted. Fields whose swollen nose and ruddy complexion testified to an advanced case of rosacea, may have helped establish a mythical connection between the condition and heavy drinking. While alcohol may exacerbate rosacea, Presutti explained, it surely does not cause it.
Cause unknown: In fact, he observed, nobody really knows the cause. “There’s a lot of disagreement” among people in the field.
One Virginia researcher, Dr. Jonathan Wilkin, blames a basic defect in the vascular system of the face; patients who do “a lot of flushing and blushing” are more susceptible to acne rosacea, he continued. “That may account for the erythema, but how do you get to the pustules and papules?”
Without a commonly accepted cause, “it’s hard to figure out why our drug is working,” Presutti remarked. Yet Curatek’s MetroGel, a water-based gel containing 0.75% metronidazole does seem to be effective.
Patients in a randomized split-face, double-blind, placebo-controlled clinical trial experienced a decrease in pustules and papules on the side of the face actively treated with metronidazole after three weeks of therapy. Maximum improvement–an average 65.1% reduction in lesions-was seen at nine weeks.
Even the side treated solely with the vehicle boasted a 14.9% reduction in lesions. Erythema was reduced. The gel also soothed itching, dryness, and burning. However, dilated blood vessels became somewhat more apparent. This may have been caused by a gel ingredient, the researchers speculated, or the reduction in erythema and lesions may simply have made them more visible.
Three mechanisms may explain the drug’s effect on rosacea, Presutti said. It may be due to metronidazole’s antibacterial action, or some acknowledged anti-inflammatory properties may be responsible. Under scrutiny as well is the drug’s activity against Demo dex foliculorum, a mite and possible culprit. It could be due to a combination of all three-or perhaps none-he noted.
MetroGel has proved to be “amazingly benign,” Presutti commented. Two patients reported tearing, but they may have applied the product too close to the eyes. (The pharmacist should be aware of this.) The company’s tests show that the drug should not irritate the eyes, though, he added.
Counseling patients: Pharmacists should advise patients not to expect immediate results, Presutti pointed out. It could take a few weeks to produce the full effect. And, finally, pharmacists should explain that certain factors can aggravate the ailment. These include spicy foods, hot liquids, alcohol, emotional stress, vigorous exercise, and exposure to sun and wind.
MetroGel, which will be available by prescription, is to be used twice a day. The company filed a New Drug Application in June 1987 and is hoping for approval by the end of the year, Presutti said.