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

Not Applicable

Completed

• Conditions: Flat Warts; HIV
• Interventions: Drug: Glycolic acid

• Registration Number: NCT01289171
• Lead Sponsor: University of Pennsylvania

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2010-10
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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Exclusion Criteria

• Key exclusion criteria included current use of potential wart treatments or other topical OTC products on the affected area(s).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycolic acid	Glycolic acid	All who met the study criteria commenced once daily use of 15% glycolic acid lotion.

Primary Outcome Measures

Name	Time	Method
Treatment efficacy of 15% glycolic acid lotion for flat warts	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	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

Name	Time	Method
HPV typing in EV-like flat warts	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.

Trial Locations

Locations (1)

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana