1 United States site
14 to 21 Years
– A diagnosis of either Sickle Cell Disease with genotype SS or S Beta-zero, or SC
– Must have recurrent sites of pain, where majority of acute pain episodes are localized
– Subjects are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, pain assessments, and other study procedures.
– Subjects who are being treated with hydroxyurea (HU) must have been on a stable dose
for at least 8 weeks prior to Visit 1 (Day 0), with the intent of remaining on the
same dose of hydroxyurea throughout the clinical trial including the
protocol-specified follow-up period unless adjustments are medically necessary due to
bone marrow suppression.
– At least 80% compliance (defined as logging pain at least once daily) with mobile
application use during 14-day lead in period from time of enrollment to time of first
– Age less than 14 or greater than 21
– History of major surgery within the past 3 months.
– Patients receiving scheduled chronic partial exchange transfusions as part of their
sickle cell disease management protocol.
– Concurrently taking another medication used in the treatment of neuropathic pain or
with the potential to affect the peripheral nervous system (e.g. gabapentin,
anti-epileptics, antidepressants, systemic alpha or beta adrenergic receptor blockers)
– Use of another topical analgesic at home in the treatment of pain episodes such as
topical lidocaine, diclofenac, or menthol (must discontinue use at the time of
– Recurrent pain secondary to an underlying condition other than vaso-occlusive pain
(avascular necrosis, scoliosis, fracture, etc.)
– Patients lacking the mental capacity to assent to the study
– Patients with another chronic inflammatory/immune disorder that could skew the
inflammatory markers listed above.
– Pregnant females
– Expectation that the subject will not be able to be followed for the duration of the
– Active use of illicit drugs and/or alcohol dependence, as determined by the
investigator. Opioid use beyond the amount necessary for pain related to the
underlying sickle cell disease as determined by the investigator.
– Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the