Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year

NCT00668733 | Completed Results

• 1 other identifier: GW01-0803
• Study Type: observational
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.

Conditions

Actinic Keratoses

Keywords

Actinic keratoses; Dermatologic disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrence of AK Lesions

  The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.

  Up to one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.

You may qualify if:

• Are willing and able to give informed consent;
• Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
• Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.

Sponsors & Collaborators

• Graceway Pharmaceuticals, LLC: lead

Related Publications (1)

• Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.

  PMID: 21283921 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic; Skin Diseases

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sharon F. Levy, MD / Sr. VP, Clinical Product Development
• Organization: Graceway Pharmaceuticals

sharon.levy@gracewaypharma.com

267-948-0400

Study Officials

• Sharon Levy, MD

  Graceway Pharmaceuticals, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 20, 2010
• Results First Posted: July 13, 2010

Record last verified: 2010-07