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

This study has been completed.
Sponsor:
Collaborators:
NeoStrata Company, Inc.
Penn Center for AIDS Research (CFAR)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01289171
First received: January 12, 2011
Last updated: February 1, 2011
Last verified: January 2011

January 12, 2011
February 1, 2011
January 2009
June 2009   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    Patients were evaluated for possible side effects of the topical medication, including erythema, scaling, burning, and irritation of the skin in the area applied.
Same as current
Complete list of historical versions of study NCT01289171 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Characterize the HPV types in the flat warts in this population.
Same as current
Not Provided
Not Provided
 
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Flat Warts (Diagnosis)
  • HIV Infections
Drug: Glycolic acid
Those who met the study criteria commenced once daily use of 15% glycolic acid lotion to the face and/or dorsal hands, with an increase to twice daily application as tolerated after two weeks of use.
Other Name: Neostrata 15% Glycolic acid
Experimental: Glycolic acid
All who met the study criteria commenced once daily use of 15% glycolic acid lotion.
Intervention: Drug: Glycolic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2010
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female HIV-positive patients 7 years of age or older with at least 15 flat warts, diagnosed clinically by one dermatologist (RLM), on the face and/or dorsal hands were included in the study.

Exclusion Criteria:

  • Key exclusion criteria included current use of potential wart treatments or other topical OTC products on the affected area(s).
Both
7 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT01289171
P30 AI 045008
No
Carrie Kovarik, MD, University of Pennsylvania
University of Pennsylvania
  • NeoStrata Company, Inc.
  • Penn Center for AIDS Research (CFAR)
Not Provided
University of Pennsylvania
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP