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
NCT number | NCT01289171 |
Other study ID # | P30AI045008 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2009 |
Est. completion date | October 2010 |
Verified date | September 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Botswana | Princess Marina Hospital | Gaborone |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | NeoStrata Company, Inc., Penn Center for AIDS Research (CFAR) |
Botswana,
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. |
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