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Phase 2
18 Years
Not Enrolling
Squamous Cell Carcinoma

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Trial Information

Inclusion Criteria:

- Male or female adults ≥ 18 years of age

- Primary, histologically confirmed SCCIS with a minimum area of 0.5 cm2 and with a
maximum diameter of 2.0 cm target SCCIS lesion suitable for excision

- Histological diagnosis made no more than 4 weeks prior to the screening visit

- Histological biopsy removed 25% or less of the target lesion

- No other dermatological disease in the SCCIS target site or surrounding area

- Willing to refrain from using non-approved lotions or creams on the target site and
surrounding area during the treatment period. Willing to refrain from washing the
treated area for at least 8 hours following the application of study medication

- Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid
the use of tanning parlors for the duration of the study

- Laboratory values for the tests listed in the Study Schedule on page 2 within the
reference ranges as defined by the central laboratory, or "out of range" test results
that are clinically acceptable to the investigator.

- Ability to follow study instructions and likely to complete all study requirements

- Written informed consent obtained, including consent for tissue to be examined and
stored by the central dermatopathologist

- Written consent to allow photographs of the target SCCIS lesion to be used as part of
the study data

- For females of childbearing potential, a negative pregnancy test at screening and
using an acceptable form of birth control (oral/implant/injectable/transdermal
contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous
relationship with a partner who has had a vasectomy)

Exclusion Criteria:

- Pregnant or lactating

- Presence of known or suspected systemic cancer

- Histological evidence of nBCC, sBCC, or any other tumor in the biopsy specimen

- Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or
micronodular growth patterns in the biopsy specimen

- History of recurrence of the target SCCIS lesion

- Evidence of dermatological disease or confounding skin condition in the treatment
area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema,
xeroderma pigmentosa

- Concurrent disease or treatment that suppresses the immune system

- Chronic medical condition that in the judgment of the investigator(s) would interfere
with the performance of the study or would place the patient at undue risk

- Known sensitivity to any of the ingredients in the study medication

- Use of a tanning parlor or other excessive or prolonged exposure to ultraviolet light
or direct sunlight during the course of the study

- Treatment with systemic chemotherapeutic agents within the 6 months prior to the
screening visit

- Use of systemic retinoids within the 6 months prior to the screening period

- Treatment with systemic immunomodulators or immunosuppressants within the 6 months
prior to the screening period

- Use of topical immunomodulators within 2 cm of the target SCCIS lesion within the 4
weeks prior to the screening period

- Treatment with the following topical agents within the 4 weeks prior to the screening
visit: levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac,
hyaluronic acid, imiquimod

- Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing,
dermabrasion, within the 6 months prior to the screening visit, if the target SCCIS
lesion is on the face

- Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the
target SCCIS lesion during the 4 weeks prior to the screening visit

- Elective surgery within 4 weeks prior to the screening visit, during the study, or 4
weeks after the treatment period

- Evidence of current chronic alcohol or drug abuse

- Current enrollment in an investigational drug or device study or participation in
such a study within 4 weeks of the screening visit

- In the investigator's opinion, evidence of unwillingness, or inability to follow the
restrictions of the protocol and complete the study

Type of Study:


Study Design:

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

Outcome Measure:

The primary efficacy endpoint will be the proportion of subjects with a complete response for the Intent-to-Treat (ITT) population.

Outcome Time Frame:

8 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell