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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
  Purpose

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 Intervention
Flat Warts (Diagnosis)
HIV Infections
Drug: Glycolic acid

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 38
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Carrie Kovarik, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01289171     History of Changes
Other Study ID Numbers: P30 AI 045008
Study First Received: January 12, 2011
Last Updated: February 1, 2011
Health Authority: United States: Institutional Review Board
Botswana: Health Research and Development Committee

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:
Acquired Immunodeficiency Syndrome
Epidermodysplasia Verruciformis
HIV Infections
Warts
DNA Virus Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Neoplasms
Papillomavirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Slow Virus Diseases
Tumor Virus Infections
Virus Diseases
Glycolic acid
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014