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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01289171
Enrollment
38
Registered
2011-02-03
Start date
2009-01-31
Completion date
2010-10-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flat Warts, HIV

Keywords

The efficacy, tolerability and safety of 15% glycolic acid lotion for treatment of diffuse flat warts among HIV+ children were investigated

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.

Interventions

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.

Sponsors

NeoStrata Company, Inc.
CollaboratorINDUSTRY
Penn Center for AIDS Research (CFAR)
CollaboratorUNKNOWN
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment efficacy of 15% glycolic acid lotion for flat wartsPatients 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 wartsPatients 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

MeasureTime frameDescription
HPV typing in EV-like flat wartsBiopsies 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.

Countries

Botswana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026