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

NCT ID: NCT01289171

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Flat Warts HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glycolic acid

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

Group Type EXPERIMENTAL

Glycolic acid

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Neostrata 15% Glycolic acid

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NeoStrata Company, Inc.

INDUSTRY

Sponsor Role collaborator

Penn Center for AIDS Research (CFAR)

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Carrie Kovarik

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Princess Marina Hospital

Gaborone, , Botswana

Site Status

Countries

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Botswana

Other Identifiers

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P30AI045008

Identifier Type: NIH

Identifier Source: org_study_id

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