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A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Phase 3
18 Years
Open (Enrolling)
Actinic Keratosis

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Trial Information

A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Inclusion Criteria:

- Subjects must be competent to understand the nature of the trial and provide informed

- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous
25 cm2 treatment area on the face or scalp.

- Subject at least 18 years of age.

- Female subjects must be of either:

- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
history of sterility (e.g. the subject is without a uterus) or,

- Childbearing potential, provided there is a confirmed negative urine pregnancy
test prior to study treatment, to rule out pregnancy.

- Female subjects of childbearing potential must be willing to use effective

Exclusion Criteria:

- Location of the selected treatment area:

- on any location other than the face or scalp

- within 5 cm of an incompletely healed wound

- within 10 cm of a suspected basal cell carcinoma (BCC) or SCC

- Prior treatment with PEP005 Gel on face or scalp.

- Selected treatment area lesions that have:

- atypical clinical appearance and/or

- recalcitrant disease

- History or evidence of skin conditions other than the trial indication that would
interfere with evaluation of the trial medication

- Clinical diagnosis/history or evidence of any medical condition that would expose a
subject to an undue risk of a significant AE or interfere with assessments of safety
and efficacy.

- Any abnormal vital signs measurements that are medically significant or would impact
the safety of the subject or the interpretation of the trial results.

- Anticipated need for hospitalization or out-patient surgery during the first 15 days
after the first trial medication application.

- Known sensitivity or allergy to any of the ingredients in PEP005 Gel

- Recent excessive exposure to ultraviolet light

- Current enrolment or participation in a clinical trial within 30 days of entry into
this study

- Subjects previously randomised in the trial

- Female subjects who are breastfeeding

Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1

- Cosmetic or therapeutic procedures within 2 cm of the selected treatment area

- Use of acid-containing therapeutic products within 2 cm of the selected treatment

- Use of topical medicated creams, ointments, lotions, gels, foams or sprays

Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:

- Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers

- Treatment with systemic medications that suppress the immune system

- Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB).

Prohibited Therapies and/or Medications within 8 weeks prior to visit 1:

- Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2
cm of the selected treatment area.

Prohibited Therapies and/or Medications within 6 months prior to visit 1

- Use of systemic retinoids or biologic / mono-clonal antibody therapies

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Complete clearance of AKs

Outcome Description:

To determine the 11-week rate of complete clearance of AKs using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Outcome Time Frame:

11 weeks

Safety Issue:


Principal Investigator

Brian Berman, MD, Ph.D

Investigator Role:

Principal Investigator


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

December 2013

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic



Mount Sinai School of Medicine New York, New York  10029
Minnesota Clinical Study Center Fridley, Minnesota  55432
Academic Dermatology Associates Albuquerque, New Mexico  87106
Center For Clinical Studies Houston, Texas  77030
Colorado Medical Research Center, Inc. Denver, Colorado  80210
North Florida Dermatology Associates, PA Jacksonville, Florida  32204
Dermatology Clinical Research Center of San Antonio San Antonio, Texas  78229
Altman Dermatology Associates Arlington Heights, Illinois  60004
Virginia Clinical Research, Inc. Norfolk, Virginia  23507
Grekin Skin Institute Warren, Michigan  48093
Philadelphia Institute of Dermatology Fort Washington, Pennsylvania  19034
Premier Clinical Research Spokane, Washington  99204
Skin Surgery Medical Group, Inc. San Diego, California  92108
The Indiana Clinical Trials Center, PC Plainfield, Indiana  46168
Oregon Medical Research Center, PC Portland, Oregon  97223
Dermatology Research Center, Inc. Salt Lake City, Utah  84124
Center for Dermatology Clinical Research Fremont, California  94538
Gwinnett Clinical Research Center, Inc. Snellville, Georgia  30078
Laser & Skin Surgery Center of Indiana Carmel, Indiana  46032
The Education & Research Foundation, Inc. Lynchburg, Virginia  24501
Suzanne Bruce and Associates, P.A. Houston, Texas  77056
Dermatology Specialists, Inc. Oceanside, California  92056
University Clinical Trials, Inc. San Diego, California  92123
About Skin Dermatology and DermSurgery, PC Englewood, Colorado  80113
The Center for Clincial and Cosmetic Research Aventura, Florida  33180
Study Protocol, Inc. Boynton Beach, Florida  33437
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare Tampa, Florida  33612
MedaPhase Newnan, Georgia  30263
Great Lakes Research Center Bay City, Michigan  48706
Henry Ford Medical Centre - New Center One, Department of Dermatology Detroit, Michigan  48202
Skin Search of Rochester, Inc. Rochester, New York  14623
Long Island Skin Cancer and Dermatologic Surgery Smithtown, New York  11787
Oregon Health & Science University, Dept. of Dermatology Portland, Oregon  97239-6483
Dermatology Research Associates, Inc. Nashville, Tennessee  37203
Arlington Research Center, Inc. Arlington, Texas  76011