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Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Superficial Basal Cell Carcinoma

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Trial Information

Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

Inclusion Criteria:

- Male or female adults ≥ 18 years of age

- Primary, histologically confirmed sBCC with a minimum area of 0.5 cm2 and with a
maximum diameter of 2.0 cm target sBCC 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 sBCC 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 sBCC 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, SCC, 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 sBCC lesion

- Evidence of dermatological disease or confounding skin condition in the treatment
area, e.g., SCC, 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 BCC 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, coricosteroids, 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 sBCC
lesion is on the face

- Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the
target sBCC 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:

Primary Efficacy Endpoint: Complete response rate defined as the proportion of patients with clinical and histological clearance of the sBCC lesion at 4 weeks post-treatment (study week 10).

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

David Wilson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Education and Research Foundation


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

January 2010

Related Keywords:

  • Superficial Basal Cell Carcinoma
  • Double-Blind
  • Placebo
  • Topical
  • Treatment
  • Dose-Ranging
  • sBCC
  • Carcinoma
  • Carcinoma, Basal Cell



Colorado Medical Research Center Denver, Colorado  80210
Dermatology Associates and Research Coral Gables, Florida  33134
Christie Clinic Champaign, Illinois  61820
Dermatology Clinical Research Center of San Antonio San Antonio, Texas  78229
Burke Pharmaceuticals Hot Springs, Arkansas  71913
Skin Surgery Medical Group, Inc. San Diego, California  92108
Gwinnett Clinical Research Snellville, Georgia  30078
Scott D. Glazer, M.D., S.C. Buffalo Grove, Illinois  60089
Long Island Skin Cancer and Dermatologic Surgery, PC Smithtown, New York  11787
Oregon Dermatology and Research Center Portland, Oregon  97210
Education & Research Foundation Lynchburg, Virginia  24501