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Vincent M. Riccardi, MD

Arch Dermatol. 1993;129(5):577-581.

Abstract
• Background and Design.—
Based on potential contributions of mast cells to neurofibroma-associated itching, pain, and tenderness, the mast cell blocker ketotifen fumarate (Zaditen, Sandoz Pharmaceuticals Corp, Hanover, NJ) has been proposed as a treatment for these symptoms. To test the hypothesis that ketotifen decreases neurofibroma-associated itching, pain, and tenderness, data were accumulated from two protocols. The first was an open-label protocol involving 25 patients with relatively severe symptoms (1170 patient-months), and the second was a double-blind protocol involving 27 patients with either relatively mild or severe neurofibroma-associated symptoms (316 patient-months). All subjects received either oral placebo or 2 to 4 mg of ketotifen fumarate per day. Using a scale of 1 to 10, symptoms were measured before, during, and after treatment.

Results.—
Itching severity scores (means) were as follows: for all patients receiving ketotifen, 7.8 before, 2.8 during, and 7.2 after treatment; for ketotifen-treated patients in the double-blind protocol, 6.6 before, 3.9 during, and 6.4 after treatment; and for placebo-treated patients, 6.0 before and 6.0 during treatment. Pain and tenderness severity scores (means) were as follows: for all patients treated with ketotifen, 7.6 before, 3.6 during, and 6.6 after treatment; for double-blind ketotifen-treated patients, 6.3 before, 4.6 during, and 6.1 after treatment; and for placebo-treated patients, 7.9 before and 6.7 during treatment.

Conclusions.—
Pretreatment, treatment, and posttreatment levels of itching, pain, and tenderness associated with neurofibromas, using both open-label and double-blind protocols, indicate that ketotifen offers a realistic approach to treating these symptoms.

(Arch Dermatol. 1993;129:577-581)

Author Affiliations
From The Neurofibromatosis Institute, La Crescenta, Calif.

Footnotes
Accepted for publication November 23, 1992.

Reprint requests to The Neurofibromatosis Institute, 5415 Briggs Ave, La Crescenta, CA 91214 (Dr Riccardi).

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