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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 Oct 19, 2026, 1:13 PM 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
Jun 2005 (Type not available)
Primary completion
May 2007 (Actual)
Completion
May 2007 (Actual)
Last update posted
Jul 20, 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 20, 2010 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00116649 live on ClinicalTrials.gov.

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