|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
3 October 2023 |
|
Main ID: |
NCT01289171 |
|
Date of registration:
|
12/01/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients
|
|
Scientific title:
|
Acquired Epidermodysplasia Verruciformis (EV) Syndrome in HIV-infected Pediatric Patients: Prospective Treatment Trial With Topical Glycolic Acid and HPV Genotype Characterization |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
38 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT01289171 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Botswana
| | | | | | | |
|
Key inclusion & exclusion 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).
Age minimum:
7 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV
|
|
Flat Warts
|
|
Intervention(s)
|
|
Drug: Glycolic acid
|
|
Primary Outcome(s)
|
|
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.]
|
|
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.]
|
|
Secondary Outcome(s)
|
|
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.]
|
|
Secondary ID(s)
|
|
P30AI045008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|