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Completed

NCT Number: NCT01289171

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

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.

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Key information

Conditions

Flat Warts HIV

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Marina Hospital

Gaborone, Botswana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Glycolic acid

Drug

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 names: Neostrata 15% Glycolic acid

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • NeoStrata Company, Inc.
  • Penn Center for AIDS Research (CFAR)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 3, 2011
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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