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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT00116649

Public ClinicalTrials.gov record NCT00116649. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Study identification

NCT ID
NCT00116649
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Graceway Pharmaceuticals, LLC
Industry
Enrollment
551 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2005
Primary completion
Apr 30, 2007
Completion
Apr 30, 2007
Last update posted
Jul 19, 2010

2005 – 2007

United States locations

U.S. sites
32
U.S. states
19
U.S. cities
30
Facility City State ZIP Site status
Not listed Phoenix Arizona 85044
Not listed Encino California 91436
Not listed Los Angeles California 90045
Not listed Riverside California 92506
Not listed San Diego California 92117
Not listed Santa Monica California 90404
Not listed Denver Colorado 80210
Not listed New Britain Connecticut 06052
Not listed Coral Gables Florida 33134
Not listed Hollywood Florida 33021
Not listed Miami Florida 33175
Not listed West Palm Beach Florida 33401
Not listed Arlington Heights Illinois 60005
Not listed Indianapolis Indiana 46256
Not listed Metairie Louisiana 70006
Not listed Boston Massachusetts 02118
Not listed Chaska Minnesota 55318
Not listed Henderson Nevada 89014
Not listed Henderson Nevada 89052
Not listed Reno Nevada 89509
Not listed Reno Nevada 89521
Not listed New York New York 10021
Not listed High Point North Carolina 27262
Not listed Raleigh North Carolina 27612
Not listed Winston-Salem North Carolina 27106
Not listed Portland Oregon 97210
Not listed Flourtown Pennsylvania 19031
Not listed Arlington Texas 76011
Not listed San Antonio Texas 78229
Not listed Woodbridge Virginia 22191
Not listed Spokane Washington 99204
Not listed Milwaukee Wisconsin 53207

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00116649, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 19, 2010 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00116649 live on ClinicalTrials.gov.

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