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A Multi-Center, Open Label, Dose-Area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)


Phase 1
18 Years
N/A
Not Enrolling
Male
Actinic Keratosis

Thank you

Trial Information

A Multi-Center, Open Label, Dose-Area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)


Inclusion Criteria:



- Must be male and at least 18 years of age.

- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal
aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion Criteria:

- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision,
curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):
within 2 weeks and within 2 cm of the selected treatment area(s).

- Treatment with immunomodulators, or interferon/ interferon inducers or systemic
medications that suppress the immune system: within 4 weeks.

- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks
and within 2 cm of the selected treatment area(s).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability (incidence of AEs, SAEs and skin responses)

Outcome Time Frame:

Screening to End of Study

Safety Issue:

Yes

Principal Investigator

George Schmieder, DO

Investigator Role:

Principal Investigator

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-022

NCT ID:

NCT00659893

Start Date:

April 2008

Completion Date:

November 2008

Related Keywords:

  • Actinic Keratosis
  • Peplin
  • PEP005
  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Park Avenue DermatologyOrange Park, Florida  32073
Radiant Research7042 East Broadway Tucson, Arizona  85710
Advanced Dermatology and Cosmetic Surgery1120 Citrus Tower Blvd, Suite 330 Clermont, Florida  34711
Skin Surgery Medical Group Inc.5222 Balboa Avenue Sixth Floor, San Diego, California  
Radiant Research Inc.Pinellas Park, Florida  33781
Medaphase IncNewnan, Georgia  30263
Karen S. Harkaway, MD LLCDelran, New Jersey  08075
J&S StudiesCollege Station, Texas  77845