A Phase 4 interventional study of imiquimod 5% cream in Actinic Keratoses, sponsored by Rigel Dermatology. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-07.
Sponsored by Rigel Dermatology · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.
Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.
The study will use a split-face design (one side of face treated and the other side untreated) to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.
369 studies on the registry are indexed under Keratosis, Actinic; 30 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 318 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →This is the only study on the registry with Rigel Dermatology as lead sponsor.
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Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
Exclusion Criteria:
Treatment within the past 90 days with any of the following:
Treatment within the past 30 days with any of the following:
Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp
Drug: imiquimod 5% cream
No treatment of treatment area on the other half of the face and/or balding scalp
1 packet (250 mg cream) 3 times per week for 4 weeks
Also known as: Aldara
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
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.
Time frame: Baseline, 4-8 weeks post-treatment
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
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.
Time frame: 4-8 weeks post-treatment
Local Skin Reactions
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.
Time frame: Post baseline to end of study (4-8 weeks post-treatment)
First patient enrolled - 08 Oct 08; last patient enrolled - 07 Jul 09; last patient completed: 09 Sep 09; Setting - private practice clinics
| Milestone | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Started | 27 |
| Completed | 26 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| Percent change | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Change from baseline, imiquimod side | -73.2 ± 27.1 |
| Change from baseline, observation side | -62.0 ± 30.3 |
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.
| Participants | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Completely cleared, imiquimod side | 8 |
| Completely cleared, observation side | 5 |
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.
| Scores on a scale | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Investigator assessed, imiquimod side | 2.1 ± 1.1 |
| Investigator assessed, observation side | 1.6 ± 1.1 |
| Patient assessed, imiquimod side | 2.6 ± 1.0 |
| Patient assessed, observation side | 1.2 ± 1.3 |
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.
| Scores on a scale | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Erythema, imiquimod side | 1.5 ± 0.7 |
| Erythema, observation side | 1.3 ± 0.5 |
| Edema, imiquimod side | 0.2 ± 0.4 |
| Edema, observation side | 0.1 ± 0.3 |
| Weeping/exudate, imiquimod side | 0.3 ± 0.7 |
| Weeping/exudate, observation side | 0.0 ± 0.0 |
| Flaking/scaling/dryness, imiquimod side | 1.4 ± 0.6 |
| Flaking/scaling/dryness, observation side | 1.2 ± 0.6 |
| Scabbing/crusting, imiquimod side | 0.9 ± 1.1 |
| Scabbing/crusting, observation side | 0.6 ± 0.7 |
| Erosion/ulceration, imiquimod side | 0.4 ± 0.7 |
| Erosion/ulceration, observation side | 0.1 ± 0.4 |
Collected over 8-12 weeks: from baseline cryotherapy visit to end of study (4-8 weeks post completion of imiquimod treatment).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cryotherapy Followed by Imiquimod 5% Cream or Observation | — | 0/27 (0%) | 3/27 (11.1%) |
| Event | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Systemic interferon reaction on areas with previous sun exposure; arms, thighs, upper chest, upper bSkin and subcutaneous tissue disorders | 1/27 |
| WeaknessGeneral disorders | 1/27 |
| Decreased appetiteGastrointestinal disorders | 1/27 |
| ColdInfections and infestations | 1/27 |
| Age, Categorical(Participants) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 17 |
| Age, Continuous(years) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Mean | 67.8 ± 9.2 |
| Sex: Female, Male(Participants) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Female | 1 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 26 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| United States | 27 |
| Actinic keratoses, total(Lesions) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Mean | 17.3 ± 4.1 |
| Actinic keratoses, Imiquimod side(Lesions) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Mean | 8.7 ± 2.2 |
| Actinic keratoses, Observation Side(Lesions) | Cryotherapy Followed by Imiquimod 5% Cream or Observation |
|---|---|
| Mean | 8.5 ± 2.3 |
The record gives a start of Oct 2008, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2010, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imiquimod