Pilot Study of Topical Imiquimod 5% Cream for Treatment of Cutaneous Neurofibromas in Adults With Neurofibromatosis 1
- Three of the participant's tumors will be treated with imiquimod cream and one tumor
(out of all the remaining tumors) will be followed without treatment (control tumor).
- Participants will be given a tube of imiquimod cream and be asked to apply it to the
three tumors 5 times per week, for a full 6 weeks (Monday through Friday).
- Participants will be required to come to the hospital for examinations on Week 1, 2, 4
and 6 (+/- 3 calendar days) and after their last dose of imiquimod cream on Weeks 9, 12
and 18 (+/- 5 calendar days. The following tests and procedures will be performed: skin
test; vital signs and measurements and photographs of the tumors. Participants will be
asked to participate in an optional skin biopsy on Week 4 and research blood tests wil
lbe taken on Day 1.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the effect of topical imiquimod 5% cream on tumor volume of cutaneous neurofibromas in adult subjects with neurofibromatosis 1
Scott R. Plotkin, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|