Trial Outcomes & Findings for Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses (NCT NCT00774787)
NCT ID: NCT00774787
Last Updated: 2016-11-07
Results Overview
Percent change = \[(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)\]/(actinic keratoses count at baseline)\]\*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
COMPLETED
PHASE4
27 participants
Baseline, 4-8 weeks post-treatment
2016-11-07
Participant Flow
First patient enrolled - 08 Oct 08; last patient enrolled - 07 Jul 09; last patient completed: 09 Sep 09; Setting - private practice clinics
Participant milestones
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Baseline characteristics by cohort
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=27 Participants
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 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
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Actinic keratoses, total
|
17.3 Lesions
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Actinic keratoses, Imiquimod side
|
8.7 Lesions
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Actinic keratoses, Observation Side
|
8.5 Lesions
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4-8 weeks post-treatmentPopulation: Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.
Percent change = \[(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)\]/(actinic keratoses count at baseline)\]\*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
Outcome measures
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=26 Participants
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
Change from baseline, imiquimod side
|
-73.2 Percent change
Standard Deviation 27.1
|
|
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
Change from baseline, observation side
|
-62.0 Percent change
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: 4-8 weeks post-treatmentPopulation: Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.
Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.
Outcome measures
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=26 Participants
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Investigator assessed, imiquimod side
|
2.1 Scores on a scale
Standard Deviation 1.1
|
|
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Investigator assessed, observation side
|
1.6 Scores on a scale
Standard Deviation 1.1
|
|
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Patient assessed, imiquimod side
|
2.6 Scores on a scale
Standard Deviation 1.0
|
|
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Patient assessed, observation side
|
1.2 Scores on a scale
Standard Deviation 1.3
|
POST_HOC outcome
Timeframe: 4-8 weeks post-treatmentPopulation: All patients enrolled.
Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
Outcome measures
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=27 Treatment areas
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment
Completely cleared, observation side
|
5 Participants
|
|
Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment
Completely cleared, imiquimod side
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post baseline to end of study (4-8 weeks post-treatment)Population: One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.
Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.
Outcome measures
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=26 Participants
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Local Skin Reactions
Erythema, imiquimod side
|
1.5 Scores on a scale
Standard Deviation 0.7
|
|
Local Skin Reactions
Erythema, observation side
|
1.3 Scores on a scale
Standard Deviation 0.5
|
|
Local Skin Reactions
Edema, imiquimod side
|
0.2 Scores on a scale
Standard Deviation 0.4
|
|
Local Skin Reactions
Edema, observation side
|
0.1 Scores on a scale
Standard Deviation 0.3
|
|
Local Skin Reactions
Weeping/exudate, imiquimod side
|
0.3 Scores on a scale
Standard Deviation 0.7
|
|
Local Skin Reactions
Weeping/exudate, observation side
|
0.0 Scores on a scale
Standard Deviation 0.0
|
|
Local Skin Reactions
Flaking/scaling/dryness, imiquimod side
|
1.4 Scores on a scale
Standard Deviation 0.6
|
|
Local Skin Reactions
Flaking/scaling/dryness, observation side
|
1.2 Scores on a scale
Standard Deviation 0.6
|
|
Local Skin Reactions
Scabbing/crusting, imiquimod side
|
0.9 Scores on a scale
Standard Deviation 1.1
|
|
Local Skin Reactions
Scabbing/crusting, observation side
|
0.6 Scores on a scale
Standard Deviation 0.7
|
|
Local Skin Reactions
Erosion/ulceration, imiquimod side
|
0.4 Scores on a scale
Standard Deviation 0.7
|
|
Local Skin Reactions
Erosion/ulceration, observation side
|
0.1 Scores on a scale
Standard Deviation 0.4
|
Adverse Events
Cryotherapy Followed by Imiquimod 5% Cream or Observation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cryotherapy Followed by Imiquimod 5% Cream or Observation
n=27 participants at risk
Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
|
|---|---|
|
Skin and subcutaneous tissue disorders
Systemic interferon reaction on areas with previous sun exposure; arms, thighs, upper chest, upper b
|
3.7%
1/27 • Number of events 1 • 8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).
|
|
General disorders
Weakness
|
3.7%
1/27 • Number of events 1 • 8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).
|
|
Gastrointestinal disorders
Decreased appetite
|
3.7%
1/27 • Number of events 1 • 8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).
|
|
Infections and infestations
Cold
|
3.7%
1/27 • Number of events 1 • 8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs must agree on communication of complete results, but may discuss individual site results. Collaborator can review complete results communications prior to public release and can embargo communications regarding trial results, if patents are to be pursued, for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the collaborator for review. The collaborator cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER