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Completed

NCT Number: NCT00115154

Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

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.

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Key information

Conditions

Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldara (imiquimod) cream, 5%

Drug

Primary outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Jun 22, 2005
Registry last updated
Feb 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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