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

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ClinicalTrials.gov Identifier: NCT01289171
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : February 3, 2011
Sponsor:
Collaborators:
NeoStrata Company, Inc.
Penn Center for AIDS Research (CFAR)
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 12, 2011
First Posted Date  ICMJE February 3, 2011
Last Update Posted Date February 3, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
  • 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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
Official Title  ICMJE Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Flat Warts (Diagnosis)
  • HIV Infections
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Glycolic acid
All who met the study criteria commenced once daily use of 15% glycolic acid lotion.
Intervention: Drug: Glycolic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2011)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Botswana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01289171
Other Study ID Numbers  ICMJE P30AI045008( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carrie Kovarik, MD, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • NeoStrata Company, Inc.
  • Penn Center for AIDS Research (CFAR)
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date January 2011

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