|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00894647 |
|
Date of registration:
|
05/05/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
|
|
Scientific title:
|
A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
247 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00894647 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Sharon Levy, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Graceway Pharmaceuticals, LLC |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- In good general health
- Negative urine pregnancy test (for women of child-bearing potential) and agree to use
an approved method of birth control while enrolled in the study.
- Prior to cryosurgery, have = 10 clinically typical (visible or palpable) AKs in an
area that exceeds 25 cm2 on the face.
- Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent and
prior to receiving study medication. Lesions previously treated with cryosurgery must
be healed sufficiently prior to randomization to study cream.
- Following cryosurgery, have = 5 clinically typical (visible or palpable) AKs in an
area that exceeds 25 cm2 on the face that are suitable for treatment with the study
cream.
Exclusion Criteria:
- Women who are pregnant, lactating, or planning to become pregnant during the study
- Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.).
- 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 within the
designated time period prior to study treatment initiation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Actinic Keratosis
|
|
Intervention(s)
|
|
Drug: imiquimod cream
|
|
Drug: placebo cream
|
|
Primary Outcome(s)
|
|
Change From Baseline in Percentage of Lesion Count
[Time Frame: Week 26]
|
|
Secondary Outcome(s)
|
|
Percent of Subjects With Complete Clearance
[Time Frame: Week 26]
|
|
Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)
[Time Frame: Weeks 2, 4, 6, 10, 14, 20, and 26]
|
|
Secondary ID(s)
|
|
GW01-0901
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|