Clinical trial NCT00115154: Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
Official title: Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratosis
Keywords: Actinic Keratosis
AK
3M Pharmaceuticals
Aldara
Imiquimod
Actinic Keratosis (AK)
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-06-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Have AK on arm or hand
* Discontinuation of sun tanning and the use of tanning beds
* Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area
* Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream
* Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete

Exclusion Criteria:

* Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions
* Participation in another clinical study
* Have previously received treatment with imiquimod within the treatment area
* Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment

Primary outcomes:
measure: The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of AK on the upper extremities when the cream is applied once daily 2 days per week for 16 weeks.
Secondary outcomes:
measure: The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Vista
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Buffalo Grove
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Delran
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Providence
country: United States
state: Rhode Island
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
city: Wenatchee
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References: