October, 10 2019

Safety and Feasibility of High-Dose Topical Capsaicin for the Treatment of Neuropathic Pain in Pediatric Sickle Cell Disease


1 United States site


14 to 21 Years




Phase 1

About the study

This study evaluates the safety and feasibility of using high dose topical capsaicin patches
for the treatment of neuropathic pain in pediatric patients with sickle cell disease, as well
as the feasibility of using a number of tests for the evaluation and monitoring of
neuropathic pain. The hypothesis, based on evidence obtained from studies in adults with
neuropathic pain related to other diseases as well as a single previously published study of
capsaicin in pediatric patients, is that capsaicin will be well tolerated in this population.
Additionally, it is hypothesized that it is feasible to monitor changes in neuropathic pain
via the testing listed below.

Study Type



Phase 1


14 to 21 Years





Inclusion Criteria

– 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
capsaicin application.

Exclusion Criteria

– 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


  • Drug

Outcome measures

  • Compliance with Quantitative Sensory Testing
  • Compliance with Serum Substance P Levels
  • Compliance with Subjective Neuropathic Pain Questionnaire
  • Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteria


  • Children's Hospital of Michigan, Detroit, Michigan, United States, 48201

More info

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