A Phase 4 interventional study of Photodynamic therapy and Imiquimod in Actinic Keratosis, sponsored by Tennessee Clinical Research Center. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-08.
Sponsored by Tennessee Clinical Research Center · Phase 4, Interventional, and Treatment
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.
Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.
Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.
Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.
This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →This is the only study on the registry with Tennessee Clinical Research Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment within the past 60 days with:
Treatment on the head within the past 60 days with:
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
Drug: Photodynamic therapy · Drug: Imiquimod
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
Drug: Imiquimod
Administered 4 weeks after completion of imiquimod therapy
Also known as: Levulan Kerasticks (aminolevulinic acid 20% solution)
Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation
Also known as: Zyclara (imiquimod 3.75% cream)
Actinic Keratosis Count
The percent change in actinic keratosis count as compared to the baseline lesion count
Time frame: Week 18 (4 weeks after randomization visit)
Complete Clearance
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
Time frame: Week 18 (4 weeks after randomization visit)
Cosmetic Appearance
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
Time frame: Week 18 (4 weeks after randomization visit)
Patients recruited from practices of 3 dermatology clinics. First patient enrolled Nov 2010; last patient completed Dec 2011.
| Milestone | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-randomized |
|---|---|---|---|
| Started | 9 | 9 | 3 |
| Completed | 9 | 9 | 0 |
| Not completed | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 2 |
The percent change in actinic keratosis count as compared to the baseline lesion count
| percent reduction in baseline count | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation |
|---|---|---|
| Actinic Keratosis Count | 81 ± 19 | 83 ± 34 |
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
| participants | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation |
|---|---|---|
| Complete Clearance | 5 | 2 |
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
| units on a scale | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation |
|---|---|---|
| Cosmetic Appearance | 1.67 ± 1 | 1.25 ± 0.71 |
Collected over 18 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imiquimod Followed by Photodynamic Therapy | — | 0/9 (0%) | 5/9 (55.6%) |
| Imiquimod Followed by Observation | — | 0/9 (0%) | 4/9 (44.4%) |
| Non-Randomized | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized |
|---|---|---|---|
| Endometrial cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/9 | 0/9 | 1/3 |
| Sore on lipGastrointestinal disorders | 0/9 | 0/9 | 1/3 |
| ErythemaSkin and subcutaneous tissue disorders | 1/9 | 0/9 | 0/3 |
| ProstatitisRenal and urinary disorders | 1/9 | 0/9 | 0/3 |
| Prickly feelingNervous system disorders | 1/9 | 0/9 | 0/3 |
| Herpes labialisInfections and infestations | 1/9 | 0/9 | 0/3 |
| Facial painGeneral disorders | 1/9 | 0/9 | 0/3 |
| HeadacheNervous system disorders | 1/9 | 0/9 | 0/3 |
| DermatitisSkin and subcutaneous tissue disorders | 0/9 | 1/9 | 0/3 |
| ColdInfections and infestations | 0/9 | 1/9 | 0/3 |
Patients completing week 18 visit
| Age, Categorical(Participants) | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 2 | 14 |
| >=65 years | 3 | 3 | 1 | 7 |
| Age, Continuous(years) | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized | Total |
|---|---|---|---|---|
| Mean | 63 ± 7 | 61 ± 6 | 66 ± 11 | 62 ± 7 |
| Sex: Female, Male(Participants) | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized | Total |
|---|---|---|---|---|
| Female | 3 | 3 | 1 | 7 |
| Male | 6 | 6 | 2 | 14 |
| Region of Enrollment(participants) | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized | Total |
|---|---|---|---|---|
| United States | 9 | 9 | 3 | 21 |
| Total facial actinic keratosis count(Patient facial actinic keratosis count) | Imiquimod Followed by Photodynamic Therapy | Imiquimod Followed by Observation | Non-Randomized | Total |
|---|---|---|---|---|
| Mean | 18.3 ± 5.6 | 19.9 ± 5.6 | 18.0 ± 2.6 | 19.0 ± 5.1 |
This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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