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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289171
• Other study ID #: P30AI045008
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Epidermodysplasia Verruciformis
• HIV

Intervention

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.

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	NeoStrata Company, Inc., Penn Center for AIDS Research (CFAR)

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	HPV typing in EV-like flat warts	Characterize the HPV types in the flat warts in this population.	Biopsies were taken at the first visit, and the HPV typing was performed on all samples after the 16 week monitoring period was complete.