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Clinical Trials/NCT00115154
NCT00115154
Completed
Phase 4

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

Graceway Pharmaceuticals, LLC0 sites270 target enrollmentMay 2005
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ConditionsKeratosis
DrugsAldara (imiquimod) cream, 5%

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Keratosis
Sponsor
Graceway Pharmaceuticals, LLC
Enrollment
270
Primary Endpoint
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.
Status
Completed
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
September 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

  • The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.

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