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A Double-blind, Randomized Controlled Trial

Murad Alam, MD; Jeffrey S. Dover, MD, FRCPC; Kenneth A. Arndt, MD

Arch Dermatol. 2002;138:510-514.

Context  Botulinum A exotoxin is used for various indications, including the treatment of dynamic forehead lines.

Objective  To determine whether injection with botulinum A exotoxin reconstituted with preservative-containing normal saline (isotonic sodium chloride) is less painful than injection with exotoxin that has been reconstituted with preservative-free saline.

Design  Two arms: (1) retrospective study; (2) double-blind, randomized controlled trial.

Setting  A multiple-physician dermatology practice.

Patients  (1) Retrospective study—20 consecutive adult patients presenting for treatment of upper-face dynamic lines; (2) prospective study—15 consecutive adult patients presenting for treatment of upper-face dynamic lines.

Intervention  In prospective study only, one side (left or right) of the face was treated with exotoxin reconstituted with preservative-containing saline, and the other side, with exotoxin reconstituted with preservative-free saline.

Main Outcome Measures  (1) Retrospective study—discomfort at current treatment (with preservative-containing saline) compared with discomfort with most recent prior treatment (with preservative-free saline); (2) prospective study—discomfort on the side treated with preservative-containing saline compared with discomfort on the side treated with preservative-free saline.

Results  (1) Retrospective study—18 (90%) of 20 patients reported that treatment with exotoxin reconstituted with preserved saline was less painful than prior treatment with exotoxin reconstituted with preservative-free saline; (2) prospective study—15 (100%) of 15 patients reported less pain in the side of their face treated with exotoxin reconstituted with preservative-containing saline (P<.001). Pain on the preservative-containing side was 54% less. No difference in treatment efficacy between the sides was observed by investigators or patients.

Conclusion  Use of preservative-containing saline to reconstitute botulinum A exotoxin can significantly decrease patient discomfort on injection.

From SkinCare Physicians, Chestnut Hill (Drs Alam, Dover, and Arndt), and Harvard Medical School, Boston (Dr Arndt), Mass; and Dartmouth Medical School, Hanover, NH (Drs Dover and Arndt).

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