A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Warts
Both
Warts
Trial Information
A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand
Inclusion Criteria:
- Male and female patients at least 18 years of age.
- A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the
dorsal hand.
- Written informed consent has been obtained.
- Agreement from the patient to allow photographs of the common wart(s) treatment area
to be taken and used as part of the study package.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Principal Investigator
Angela Smith
Investigator Role:
Study Director
Investigator Affiliation:
Peplin Operations Pty Ltd
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-019
NCT ID:
NCT00546611
Start Date:
October 2007
Completion Date:
Related Keywords:
- Warts
- PEP005
- Common Wart(s)
- Common warts (verruca[e] vulgaris)
- Warts
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