Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin

Inclusion Criteria

- INCLUSION CRITERIA:

1. Subjects must be age greater than or equal to18 years.

2. Subjects must have a prior biopsy-proven diagnosis of cutaneous leiomyoma.

3. Subjects must have at least 1 symptomatic leiomyomas or regions less than or
equal to 60 cm(2) of leiomyomas with pain characterized as greater than 4 based
on a 10-point scale, indicating pain of at least moderate severity.

4. Pain episodes must occur at least once a week.

5. Subjects must have the ability to participate fully and comply with the
procedures of the protocol in the opinion of the investigator.

6. Written informed consent has been obtained including consenting to have tissue
samples stored, however subjects are allowed to refuse sample storage.

7. Negative urine or serum pregnancy test in females of childbearing potential.

8. Subjects who are clinically stable such that they can be expected to complete
the 24-week study.

EXCLUSION CRITERIA:

1. Subjects with allergies to BTX-A.

2. Females with a positive pregnancy test, or who are breast-feeding, planning a
pregnancy during the study, who think that they may be pregnant at the start of the
study or females of childbearing potential who are unable or unwilling to use a
reliable form of contraception during the study.

3. Subjects with neuromuscular junction disorders (ie. myasthenia gravis or
Lambert-Eaton syndrome) or peripheral motor neuropathic diseases (ie. amyotrophic
lateral sclerosis or motor neuropathy).

4. Subjects with infection at the intended sites of injection.

5. Subjects who have had prior Botulinum toxin product within the past 6 months.

6. Subjects with pain resulting from other disease(s), specifically:

- pain that requires intermittent or ongoing treatment with narcotics

- severe, debilitating, or acute pain originating from sources other than
leiomyomas

7. Subjects taking pain medications, neuroactive agents, or other therapy directed
toward treatment of cutaneous leiomyomas concurrently or within 5 days or 5
half-lives (whichever is longer) of BTX-A treatment, other than specified rescue pain
medications). Patients currently on therapy directed toward OTHER mild to moderate
chronic pain will be evaluated on a case-by-case basis for inclusion. Patients with
well-controlled mild to moderate chronic pain such as that associated with
osteoarthritis, who do not require narcotic therapy, will NOT be excluded. Aspirin
for pain relief or for other indications is also acceptable.

8. Subjects with late-stage cancers or unstable disease (such as hemodynamic
instability, i.e., systolic or diastolic blood pressure fall of 20 mm Hg or greater
from the stable patient's baseline measurement).

9. A condition or situation that, in the investigator's opinion, may put the subject at
significant risk or interfere significantly with the subject's participation in the
study.