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A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand


Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or
sores on the top layer of the skin which if left untreated can progress to skin cancer.
Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long
treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus
being researched.


Inclusion Criteria:



- Male patients at least 18 years of age.

- Post-menopausal female patients

- 4 to 8 clinically typical, visible and discrete AK lesions within an area on the
dorsum of one hand.

- Written informed consent has been obtained.

- Agreement from the patient to allow photographs of the selected AK treatment area to
be taken and used as part of the study data package.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)

Outcome Time Frame:

57 days

Safety Issue:

Yes

Principal Investigator

Janice Drew

Investigator Role:

Study Director

Investigator Affiliation:

Peplin

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-018

NCT ID:

NCT00544297

Start Date:

October 2007

Completion Date:

January 2008

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Topical
  • Dermatology
  • Hand
  • Keratosis
  • Keratosis, Actinic

Name

Location

Dermatology Associates of Tyler Tyler, Texas  75703
Skin Surgery Medical Group Inc 5222 Balboa Avenue Sixth Floor San Diego, California  92117
Gwinnett Clinical Research Centre 2383 Pate St, Snellville, Georgia  30078-3250
Dermatology Clinical Research Centre of San Antonio 7810 Louis Pasteur Dr Suite 200 San Antonio, Texas  78229-3409