Status:

COMPLETED

Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Lead Sponsor:

Graceway Pharmaceuticals, LLC

Conditions:

Keratosis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluat...

Detailed Description

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the Unit...

Eligibility Criteria

Inclusion

  • Are at least 18 years of age.
  • Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

Exclusion

  • Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
  • Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2007

Estimated Enrollment :

551 Patients enrolled

Trial Details

Trial ID

NCT00116649

Start Date

June 1 2005

End Date

May 1 2007

Last Update

July 20 2010

Active Locations (32)

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Page 1 of 8 (32 locations)

1

Phoenix, Arizona, United States, 85044

2

Encino, California, United States, 91436

3

Los Angeles, California, United States, 90045

4

Riverside, California, United States, 92506