Clinical Trial: Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characte

Brief Summary: Many human immunodeficiency virus (HIV)-positive children are afflicted with diffuse flat warts that have been recalcitrant to multiple treatments.The aim of this prospective study was to evaluate the efficacy, safety and tolerability of 15% glycolic acid lotion (NeoStrata) for treatment of flat warts in HIV-positive children in Botswana. Additionally, the investigators characterized the flat warts in this population, including Human Papillomavirus (HPV) type(s) and degree of immunosuppression within the patients.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Treatment efficacy of 15% glycolic acid lotion for flat warts [ Time Frame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks. ]
    Our primary objective is to determine the efficacy of 15% glycolic acid lotion for improving the cosmetic appearance of flat warts in HIV infected children and young adults on antiretroviral therapy.
  • Safety and tolerability of 15% glycolic acid lotion for flat warts [ Time Frame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks. ]
    Patients were evaluated for possible side effects of the topical medication, including erythema, scaling, burning, and irritation of the skin in the area applied.


Original Primary Outcome: Same as current

Current Secondary Outcome: HPV typing in EV-like flat warts [ Time Frame: Biopsies were taken at the first visit, and the HPV typing was performed on all samples after the 16 week monitoring period was complete. ]

Characterize the HPV types in the flat warts in this population.


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: January 12, 2011
Date Started: January 2009
Date Completion:
Last Updated: February 1, 2011
Last Verified: January 2011