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A Multi-Center, Randomized, Double-Blind, Double-Dummy, Vehicle-Controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.


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

Thank you

Trial Information

A Multi-Center, Randomized, Double-Blind, Double-Dummy, Vehicle-Controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.


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


Inclusion

1. Male patients at least 18 years of age.

2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months,
or without a uterus.

3. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2
treatment area on the arm, shoulder, chest, back or scalp.

4. Screening laboratory values within the reference ranges as defined by the central
laboratory or "out of range" test results that are clinically acceptable to the
Investigator.

5. Ability to follow study instructions and likely to complete all study requirements.

6. Written informed consent has been obtained.

7. Written Authorization for Use and Release of Health and Research Study Information
has been obtained.

8. 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.

Exclusion

1. Females of child bearing potential (a female is considered of childbearing potential
unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or
is without a uterus).

2. Location of the selected AK treatment area:

1. anywhere on the face

2. within 5 cm of an incompletely healed wound

3. on the breast area of women

4. on the dorsum of the hand

3. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic,
recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns
within the selected AK treatment area.

4. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
within the selected AK treatment area or within 10 cm of the selected AK treatment
area.

5. Presence of known or suspected metastatic disease.

6. History or evidence of skin conditions other than AK that would interfere with
evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).

7. Known sensitivity to any of the ingredients in the study drug.

8. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision,
curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):

- within 2 cm of the selected AK treatment area during the 4 weeks prior to
screening visit

9. Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic
therapy:

- within 2 cm of the selected AK treatment area during the 24 months prior to
screening visit or

- anywhere during the 4 weeks prior to screening visit

10. Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin,
camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathiopine, chlorambucil,
nitrogen mustard, methotrexate), or interferon/ interferon inducers:

- within 4 weeks prior to screening visit

11. Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids,
such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light
chemical peels:

- within 2 cm of the selected AK treatment area during the 4 weeks prior to
screening visit

12. Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:

- anywhere during the 6 months prior to screening visit

13. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):

- within 6 months prior to screening visit

14. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight,
tanning beds).

15. Use of topical salves, artificial tanners or topical steroids:

- On the selected AK treatment area during the 4 weeks prior to screening visit

16. Anticipated need for hospitalization (in-patient) or surgery (except that specified
in exclusion criteria 8) during the study.

17. Concurrent disease that suppresses the immune system (e.g. HIV, hepatitis).

18. Uncontrolled systemic disease (e.g. uncontrolled hypertension [a systolic blood
pressure of 180 mmHg or greater and/or a diastolic blood pressure of 110 mmHg or
greater], poorly controlled diabetes [fasting blood sugar of 350 mg/dl or greater]).

19. Use of systemic medications that suppress the immune system (e.g. cyclosporine,
prednisone, methotrexate, alefacept, infliximab):

- within 4 weeks prior to screening visit

20. Current evidence of chronic alcohol or drug abuse.

21. Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of entry into this study or entry into another
investigational drug or device study while enrolled in this study.

22. A condition or situation which in the Investigator's opinion may put the patient at
significant risk, may confound the study results, or may interfere significantly with
the patient's participation in the study [e.g. patients who required hospitalization
in the 2 months prior to screening for an acute or chronic condition].

23. Selected AK treatment area within 5 cm of an AK lesion previously treated with
PEP005, for those patients who have participated in earlier PEP005 topical gel
trials. Patients enrolled in Treatment Phase 1 can not be re-enrolled into Treatment
Phase 2.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Safety

Principal Investigator

Lawrence Anderson, Dr

Investigator Role:

Principal Investigator

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-006

NCT ID:

NCT00375739

Start Date:

September 2006

Completion Date:

June 2007

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Topical
  • Solar Keratosis
  • Sun Spots
  • Dermatology
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location

Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Medical Affiliated Research Center, Inc.Huntsville, Alabama  35801
Dermatology Associates and ResearchCoral Gables, Florida  33134
Dermatology Clinical Research Center of San AntonioSan Antonio, Texas  78229
Burke Pharmaceutical ResearchHot Springs, Arkansas  71913
Radiant ResearchGreer, South Carolina  29651
Dermatology Associates of TylerTyler, Texas  75703
Radiant Research7042 East Broadway Tucson, Arizona  85710
Advanced Dermatology and Cosmetic Surgery1120 Citrus Tower Blvd, Suite 330 Clermont, Florida  34711
Palm Beach Aesthetics1500 N. Dixie Highway, West Palm Beach, Florida  33401
North Florida Dermatology Associates P.A.1541 Riverside Avenue, Jacksonville, Florida  32204
Park Avenue Dermatology, PA1543 Kingsley Ave, Bldg 1 and 16 Orange Park, Florida  32073
Dermatology Associates of Tallahassee1707 Riggins Road, Tallahassee, Florida  32308
Gwinnett Clinical Research Centre, Inc2383 Pate St, Snellville, Georgia  30078-3250
Medaphase, Inc710 Newnan Crossing Bypass, Suite B Newnan, Georgia  30263
Henry Ford Health Center- Farmington Road6530 Farmington Road, West Bloomfield, Michigan  48322
St. Luke's/Roosevelt Hospital Center Dermatology1090 Amsterdam Avenue, Suite 11D New York, New York  10025
Mount Sinai Hospital School of Medicine5 East 98th Street, New York, New York  10029
Radiant Research1275 Oletangy River Rd, Suite 202, Columbus, Ohio  43212
University Dermatology Consultants, Inc., Dermatology Clinical Research Center222 Piedmont Ave, Suite 5300, Cincinnati, Ohio  45219-4215
Oregon Medical ResearchCentre9495 SW Locust St., Suite G Portland, Oregon  97223
Dermatology Research Centre3920 South 1100 East Suite 210 & 310 Salt Lake City, Utah  84124
Skokane Dermatology Clinic, PLLP.104 West 5th Ave, Suite 330, Spokane, Washington  99204