Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
This study has been completed.
Sponsor:
University of Pennsylvania
Collaborators:
NeoStrata Company, Inc.
Penn Center for AIDS Research (CFAR)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01289171
First received: January 12, 2011
Last updated: February 1, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Flat Warts (Diagnosis) HIV Infections |
Drug: Glycolic acid |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Treatment efficacy of 15% glycolic acid lotion for flat warts [ Time Frame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks. ] [ Designated as safety issue: No ]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 [ Time Frame: Patients were evaluated every two weeks for eight weeks and monthly for the next eight weeks, for a total monitoring period of 16 weeks. ] [ Designated as safety issue: Yes ]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:
- HPV typing in EV-like flat warts [ Time Frame: Biopsies were taken at the first visit, and the HPV typing was performed on all samples after the 16 week monitoring period was complete. ] [ Designated as safety issue: No ]Characterize the HPV types in the flat warts in this population.
| Enrollment: | 38 |
| Study Start Date: | January 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Glycolic acid
All who met the study criteria commenced once daily use of 15% glycolic acid lotion.
|
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.
Other Name: Neostrata 15% Glycolic acid
|
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Carrie Kovarik, MD, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01289171 History of Changes |
| Other Study ID Numbers: | P30 AI 045008 |
| Study First Received: | January 12, 2011 |
| Last Updated: | February 1, 2011 |
| Health Authority: | United States: Institutional Review Board Botswana: Health Research and Development Committee |
Keywords provided by University of Pennsylvania:
|
The efficacy, tolerability and safety of 15% glycolic acid lotion for treatment of diffuse flat warts among HIV+ children were investigated |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Epidermodysplasia Verruciformis Warts Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Papillomavirus Infections DNA Virus Infections Skin Diseases, Viral Tumor Virus Infections Neoplasms Skin Diseases, Infectious Skin Diseases Glycolic acid Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 26, 2013
