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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:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Flat Warts (Diagnosis) HIV Infections Drug: Glycolic acid

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization
Study Start Date : January 2009
Primary Completion Date : June 2009
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Warts
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Glycolic acid
All who met the study criteria commenced once daily use of 15% glycolic acid lotion.
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289171


Locations
Botswana
Princess Marina Hospital
Gaborone, Botswana
Sponsors and Collaborators
University of Pennsylvania
NeoStrata Company, Inc.
Penn Center for AIDS Research (CFAR)
More Information

Responsible Party: Carrie Kovarik, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01289171     History of Changes
Other Study ID Numbers: P30AI045008 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: January 2011

Keywords provided by University of Pennsylvania:
The efficacy, tolerability and safety of 15% glycolic acid lotion for treatment of diffuse flat warts among HIV+ children were investigated

Additional relevant MeSH terms:
HIV Infections
Epidermodysplasia Verruciformis
Warts
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Papillomavirus Infections
DNA Virus Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Glycolic acid
Keratolytic Agents
Dermatologic Agents