Trial Outcomes & Findings for Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy (NCT NCT01203878)
NCT ID: NCT01203878
Last Updated: 2014-12-08
Results Overview
The percent change in actinic keratosis count as compared to the baseline lesion count
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Week 18 (4 weeks after randomization visit)
Results posted on
2014-12-08
Participant Flow
Patients recruited from practices of 3 dermatology clinics. First patient enrolled Nov 2010; last patient completed Dec 2011.
Patients required to complete topical treatment phase prior to randomization to photodynamic therapy or observation. Three subjects discontinued prior to randomization, 2 for adverse events and 1 for withdrawal of consent.
Participant milestones
| Measure |
Imiquimod Followed by Photodynamic Therapy
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
Non-randomized
Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
3
|
|
Overall Study
COMPLETED
|
9
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Imiquimod Followed by Photodynamic Therapy
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
Non-randomized
Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Baseline characteristics by cohort
| Measure |
Imiquimod Followed by Photodynamic Therapy
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
Non-Randomized
n=3 Participants
Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 7 • n=5 Participants
|
61 years
STANDARD_DEVIATION 6 • n=7 Participants
|
66 years
STANDARD_DEVIATION 11 • n=5 Participants
|
62 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Total facial actinic keratosis count
|
18.3 Patient facial actinic keratosis count
STANDARD_DEVIATION 5.6 • n=5 Participants
|
19.9 Patient facial actinic keratosis count
STANDARD_DEVIATION 5.6 • n=7 Participants
|
18.0 Patient facial actinic keratosis count
STANDARD_DEVIATION 2.6 • n=5 Participants
|
19.0 Patient facial actinic keratosis count
STANDARD_DEVIATION 5.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 18 (4 weeks after randomization visit)Population: Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.
The percent change in actinic keratosis count as compared to the baseline lesion count
Outcome measures
| Measure |
Imiquimod Followed by Photodynamic Therapy
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
n=8 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
|---|---|---|
|
Actinic Keratosis Count
|
81 percent reduction in baseline count
Standard Deviation 19
|
83 percent reduction in baseline count
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Week 18 (4 weeks after randomization visit)Population: Randomized patients with a week 18 actinic keratosis count.
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
Outcome measures
| Measure |
Imiquimod Followed by Photodynamic Therapy
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
|---|---|---|
|
Complete Clearance
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 18 (4 weeks after randomization visit)Population: Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.
Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments: INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation 1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity
Outcome measures
| Measure |
Imiquimod Followed by Photodynamic Therapy
n=9 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
n=8 Participants
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
|---|---|---|
|
Cosmetic Appearance
|
1.67 units on a scale
Standard Deviation 1
|
1.25 units on a scale
Standard Deviation 0.71
|
Adverse Events
Imiquimod Followed by Photodynamic Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Imiquimod Followed by Observation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Non-Randomized
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imiquimod Followed by Photodynamic Therapy
n=9 participants at risk
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
|
Imiquimod Followed by Observation
n=9 participants at risk
Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
|
Non-Randomized
n=3 participants at risk
Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Renal and urinary disorders
Prostatitis
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Nervous system disorders
Prickly feeling
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Infections and infestations
Herpes labialis
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
General disorders
Facial pain
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Infections and infestations
Cold
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Infections and infestations
Flu-like symptoms
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Infections and infestations
Fever blister
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
33.3%
1/3 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Gastrointestinal disorders
Sore on lip
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
33.3%
1/3 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Renal and urinary disorders
Bladder infection
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
|
Infections and infestations
Sinus infection
|
11.1%
1/9 • Number of events 1 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/9 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
0.00%
0/3 • 18 weeks
From study entry (Visit 1) to end of study (visit 5).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Up to 30 days to review presentations and/or manuscripts. Up to an additional 60 days, if applicable, to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER