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Open-Label Study to Assess Safety and Efficacy of Imiquimod 5% Cream Applied 3 Days Per Week in 1 or 2 Cycles for Treatment of Actinic Keratoses on the Head


Phase 3
18 Years
75 Years
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

Open-Label Study to Assess Safety and Efficacy of Imiquimod 5% Cream Applied 3 Days Per Week in 1 or 2 Cycles for Treatment of Actinic Keratoses on the Head


This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic
keratoses on the head to reduce the size of lesions. The objective is to analyze the effect
of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is
applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is
defined as the proportion of subjects with no clinically visible AK lesions in the treatment
area at the end of cycle 1 or the end of cycle 2.


Inclusion Criteria:



- At least 18 years of age.

- Have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic,
non-hypertrophic AK lesions located within a contiguous 25 cm2 treatment area
(balding scalp or face, but not both).

- Free of any significant findings (e.g. tattoos) in the potential application site
area that may impair examination of treatment or surrounding area.

- Willing to eliminate tanning bed/sun parlor use for duration of study.

Exclusion Criteria:

- Evidence of clinically significant, unstable cardiovascular or immunosuppressive,
hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or
gastrointestinal abnormalities or disease.

- Any dermatological disease and or condition in the treatment or surrounding area that
may be exacerbated by treatment with imiquimod or cause difficulty with examination
(e.g. rosacea, psoriasis, atopic dermatitis, eczema).

- Confirmed SCC, BCC anywhere on the head.

- Share a household where there is a person participating in a concurrent clinical
study of imiquimod or being treated with imiquimod 5% topical cream.

- Active chemical dependency or alcoholism, as assessed by investigator.

- Females who are pregnant, breast-feeding or considering becoming pregnant while on
the study.

- Females with childbearing unwilling to practice an effective method of contraception,
as defined by the investigator for the duration of the study as well as one month
after completion.

- Received any treatment, products or procedures within the designated time period
prior to the prestudy visit as listed on page 4 of the protocol (Version 03 dd March
2003).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete clearance rate - defined as the proportion of subjects at the end of cycle 1 or cycle 2 with no (zero) clinically visible AK lesions in the treatment area.

Principal Investigator

Jason K Rivers, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Dermatology, University of British Columbia

Authority:

Canada: Health Canada

Study ID:

AK-IMIQUIMOD CYCLING

NCT ID:

NCT00175643

Start Date:

February 2005

Completion Date:

November 2005

Related Keywords:

  • Actinic Keratoses
  • actinic keratoses
  • imiquimod
  • pre-malignant
  • squamous cell carcinoma
  • immunosuppression
  • Keratosis
  • Keratosis, Actinic

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