Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00116649
Other study ID # 1520-IMIQ
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2005
Last updated July 14, 2010
Start date June 2005
Est. completion date May 2007

Study information

Verified date July 2010
Source Graceway Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 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.


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 United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.


Recruitment information / eligibility

Status Completed
Enrollment 551
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Are at least 18 years of age.

- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
imiquimod cream
imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Del Rosso JQ, Sofen H, Leshin B, Meng T, Kulp J, Levy S. Safety and Efficacy of Multiple 16-week Courses of Topical Imiquimod for the Treatment of Large Areas of Skin Involved with Actinic Keratoses. J Clin Aesthet Dermatol. 2009 Apr;2(4):20-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experienced an Adverse Event Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment. from first dose up to 18 months Yes
Secondary Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count At Month 18 No
See also
  Status Clinical Trial Phase
Completed NCT00239135 - Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Phase 2
Recruiting NCT06206681 - Efficacy and Safety of Ultrapulse Carbon Dioxide Laser Treatment in Eyelid Tumors
Completed NCT00115154 - Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands Phase 4
Recruiting NCT04336514 - A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures N/A
Recruiting NCT05942794 - Identification of Oral Lesions Through an Autofluorescence System N/A
Withdrawn NCT02851693 - Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection N/A
Withdrawn NCT02813902 - A Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors Phase 1
Completed NCT00121511 - The Effect of Efudex Treatment on Photoaged Skin N/A
Completed NCT00114023 - 1-Year Follow up to the 1473-IMIQ Study Phase 3
Completed NCT05060237 - Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp Phase 1
Recruiting NCT02737176 - Tobacco Cessation Intervention Study for Oral Diseases N/A
Completed NCT00110682 - Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses Phase 4