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Phase 2a Randomized, Placebo-Controlled, Double-Blind Trial of Topical Perillyl Alcohol in Sun Damaged Skin


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Precancerous Condition

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Trial Information

Phase 2a Randomized, Placebo-Controlled, Double-Blind Trial of Topical Perillyl Alcohol in Sun Damaged Skin


OBJECTIVES:

Primary

- To determine if topical administration of perillyl alcohol (POH) cream can reverse
actinic damage as evidenced by normalization of quantitative skin histopathology scores
in skin tissue biopsy samples from patients with moderate to severe sun damage.

Secondary

- To determine if topically administered POH results in significant alterations in
surrogate endpoint biomarkers of epidermal cell proliferation, including optical
coherence tomography, p53 expression, c-Fos expression, and apoptosis (as measured by
activated caspase-3 expression).

- To determine if topically administered POH results in normalization of nuclear
chromatin patterns in skin biopsy tissue from these patients, as determined by
karyometric analysis.

- To determine if topical POH can be administered safely to the forearms of these
patients.

OUTLINE: Patients are randomized to 1 of 3 arms.

- Arm I: Patients apply a placebo cream topically to each dorsal forearm twice daily for
3 months in the absence of unacceptable toxicity.

- Arm II: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal
forearm twice daily for 3 months in the absence of unacceptable toxicity.

- Arm III: Patients apply POH cream (0.76%) as in arm II. Patients undergo tissue
sampling of the right or left dorsal forearm and of physician-selected representative
actinic keratoses (AK) at baseline and after completion of study therapy. Tissue
samples are assessed for changes in patterns of biomarker expression (i.e., p53,
apoptosis, c-Fos histopathology) and karyometry. After completion of study therapy,
patients undergo tissue sampling of the opposite forearm as well as blood sample
collection to determine perillyl alcohol (POH) levels in blood and biopsy samples.
Urine is also collected and analyzed for safety at the end of treatment. Digital
photographs of the forearms and hands are obtained at baseline and after 3 months of
study treatment. Optical coherence tomography imaging is also performed on pre- and
post-biopsy sites to quantify the effect of POH on sun damage and AK in skin.

After completion of study treatment, patients are followed monthly.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Resident of Pima or adjoining Southern Arizona county

- Patients outside of Pima County are also eligible

- Sun damaged skin as judged by the study physician and quantifiable, clinically
diagnosed, and visible actinic keratoses (AK) on both dorsal forearms, with at least
two AK on each arm

- AK lesions must not be clustered, confluent, or too numerous to count accurately

- Presence of AK on sites other than the test area allowed

- No significant inflammation or irritation of the skin of the upper extremities that
is not clinically diagnosed as sun damage or AK

- Patients must agree to limit sun exposure as much as possible and may continue their
normal pattern of sunscreen use

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Females must not be of childbearing potential, and therefore must be post-menopausal
or surgically sterile by hysterectomy

- Not pregnant or nursing

Exclusion criteria:

- Concurrent skin malignancy or disorder of the upper extremities

- Patients with SCC or BCC in an area other than the test area are eligible upon
excision of the SCC or BCC

- Patients who are immunosuppressed by virtue of medication or disease

- Serious concurrent illness that could interfere with study regimen

- Invasive cancer within the past 5 years

PRIOR CONCURRENT THERAPY:

- At least 30 days since prior topical medications to the skin of the upper extremities
except for emollients or sunscreens

- At least 30 days since prior and no concurrent mega-doses of vitamins, defined as any
of the following:

- More than 5 times the recommended daily allowance

- More than 5 capsules of multivitamins

- 400 IU of vitamin E

- 200 μg of selenium

- 1 gm of vitamin C

- At least 6 months since prior and no concurrent therapy for squamous cell carcinoma
(SCC) or basal cell carcinoma (BCC) anywhere in the test area (i.e., the forearms or
hands)

- Treatment for SCC or BCC on sites other than the test area is allowed

- At least 4 weeks since prior surgical biopsy, surgical excision, or cryotherapy for
AK in the test area and the sites must have healed

- At least 6 months since prior topical treatment (e.g., 5-fluorouracil or imiquimod)
for AK

- No concurrent therapy that may interfere with clinical evaluations

- No concurrent topical drug treatment (e.g., retinoids, aminolevulinic acid,
diclofenac sodium, imiquimod, or fluorouracil) to any area of skin, including test
area

- No concurrent enrollment in another clinical trial

- No concurrent topical citrus peel or consumption of citrus peel

- No chemotherapy for cancer within the past 5 years

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Change in histopathology grading

Safety Issue:

No

Principal Investigator

Steve Stratton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

Unspecified

Study ID:

CDR0000582634

NCT ID:

NCT00608634

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Precancerous Condition
  • actinic keratosis
  • Keratosis
  • Keratosis, Actinic
  • Precancerous Conditions

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724