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Phase I/II Evaluation of Topical Application of 20% Betulinic Acid Ointment in the Treatment of Dysplastic Nevi With Moderate to Severe Dysplasia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Dysplastic Nevus Syndrome

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Trial Information

Phase I/II Evaluation of Topical Application of 20% Betulinic Acid Ointment in the Treatment of Dysplastic Nevi With Moderate to Severe Dysplasia


Approximately 200 patients may be enrolled and screened in order to find twenty-eight (28)
patients who qualify to be involved in this research at UIC.

Dysplastic melanocytic nevus (DMN) is a histopathologic term implying a disordered
proliferation of melanocytes associated with discontinuous and variable cellular atypia. DMN
is graded into mild, moderate, and severe based on standard histological criteria. DMN is
considered to be a likely precursor for melanoma, and individuals with DMN often have
multiple instances of it scattered over their trunk and extremities. For this study, only
DMN where the dysplasia is either moderate or severe will be included.


Inclusion Criteria:



- All races are eligible for entry into the Study.

- All patients must have been histologically documented (by a punch biopsy) for
dysplastic nevi with moderate to severe dysplasia (DMN). A similar biopsy proven DMN
that will serve as the control needs to be available.

- Patients must be healthy and active in normal pursuits of life and be able to provide
informed written consent.

- Localized dermatological conditions like psoriasis or actinic keratosis will not be
an exclusion criteria.

- Patients must be ambulatory with an ECOG status < 2; they will not be hospitalized as
part of the Study.

- All patients in this study will have, in addition to a normal clinical examination, a
thorough skin examination. Whenever possible, periodic photographs of their lesions
will be taken. Additional tests for all patients within 30 days of the initiation of
topical application include urinalysis, a liver function test (LFT), and blood tests
for complete blood count (CBC), BUN, and creatinine.

Exclusion Criteria:

- Women who are pregnant and/or nursing will be excluded. A pregnancy test will be
performed on each pre-menopausal woman within two days of entry into the Study, and a
negative pregnancy test must be recorded on the case report form prior to initiating
use of the topical application.

- Patients who are being treated for other chronic debilitating diseases (cardiac,
pulmonary, or any other organ specific diseases).

- Immuno-suppressed patients, either due to chemotherapy and radiation therapy or known
immunodeficiency diseases (e.g., AIDS).

- Patients with other active malignancies within the past five years, excluding
noninvasive skin or cervical carcinoma.

- Patients with any other serious medical or psychiatric illness that would prevent
informed consent.

- Patients with extensive chronic skin diseases such as extensive psoriasis, atopic
dermatitis, or xeroderma pigmentosa will be excluded from the Study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Tapas K. Das Gupta, MD, PhD, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois at Chicago Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

2003-0811

NCT ID:

NCT00346502

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Dysplastic Nevus Syndrome
  • Dysplastic Nevus Syndrome
  • Nevus
  • Nevus, Pigmented
  • Hyperplasia

Name

Location
University of Illinois at Chicago Medical Center Chicago, Illinois  60612