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

NCT01289171 | Completed

• 1 other identifier: P30AI045008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Treatment efficacy of 15% glycolic acid lotion for flat warts

  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.

  Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.

• Safety and tolerability of 15% glycolic acid lotion for flat warts

  Patients were evaluated for possible side effects of the topical medication, including erythema, scaling, burning, and irritation of the skin in the area applied.

  Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Glycolic acid

EXPERIMENTAL

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

Drug: Glycolic acid

Interventions

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.

Also known as: Neostrata 15% Glycolic acid

Glycolic acid

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• NeoStrata Company, Inc.: collaborator
• Penn Center for AIDS Research (CFAR): collaborator

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

MeSH Terms

Interventions

glycolic acid

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: February 3, 2011
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2010
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

BO (1)