Trial Outcomes & Findings for Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream (NCT NCT03914417)
NCT ID: NCT03914417
Last Updated: 2021-01-20
Results Overview
The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Day 70
Results posted on
2021-01-20
Participant Flow
Recruitment/Enrollment from Jan 1, 2013 - Jan 1, 2015
Participant milestones
| Measure |
Imiquimod 3.75% Cream
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Imiquimod 3.75% Cream
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
Baseline characteristics by cohort
| Measure |
Imiquimod 3.75% Cream
n=21 Participants
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 70The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.
Outcome measures
| Measure |
Imiquimod 3.75% Cream
n=19 Participants
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Number of Responders
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 70The safety of imiquimod 3.75% on the face and/or scalp was determined by the number of treatment related adverse events that occur during the study.
Outcome measures
| Measure |
Imiquimod 3.75% Cream
n=19 Participants
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Number of Treatment Related Adverse Events
|
8 events
|
Adverse Events
Imiquimod 3.75% Cream
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imiquimod 3.75% Cream
n=19 participants at risk
Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
1/19 • 70 days
|
|
Blood and lymphatic system disorders
Left Post-auricular lymphadenopathy
|
10.5%
2/19 • 70 days
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash, forearms
|
5.3%
1/19 • 70 days
|
|
Skin and subcutaneous tissue disorders
Pruritus on treatment area
|
10.5%
2/19 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
5.3%
1/19 • 70 days
|
|
Skin and subcutaneous tissue disorders
Intolerable LSR
|
5.3%
1/19 • 70 days
|
|
General disorders
Flu-like symptoms
|
10.5%
2/19 • 70 days
|
|
Infections and infestations
Viral Upper Respiratory Infection
|
10.5%
2/19 • 70 days
|
|
Skin and subcutaneous tissue disorders
Facial Swelling
|
5.3%
1/19 • 70 days
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.3%
1/19 • 70 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral Aphthous Ulcer
|
5.3%
1/19 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Fracture of toe
|
5.3%
1/19 • 70 days
|
Additional Information
Dr. Sharon Rose
Icahn School of Medicine at Mount Sinai
Phone: 212-241-3288
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place