Phase 4
N=27
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
Actinic Keratoses
Bottom Line
View on ClinicalTrials.gov: NCT00774787 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment — -73.2; -62.0 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- imiquimod 5% cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Dermatology
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment |
-73.2; -62.0 | — |
| SECONDARY Cosmetic Appearance Score at 4-8 Weeks Post-treatment |
2.1; 1.6; 2.6; 1.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of actinic keratoses
- Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
- each area with a minimum of 25 cm^2 and a maximum of 50 cm^2
- each area with at least 6 typical, non-hypertrophic target AKs
- with target AK lesion counts of +/- 1 lesion between the areas
- each area that the patient can distinguish with respect to study drug application
- Able to comply with all study requirements
- Are willing and able to give written informed consent
Exclusion Criteria
- Uncontrolled intercurrent or chronic illness
- Systemic immunocompromise due to disease or treatment
- Clinically relevant systemic autoimmune disease
- Pregnant or nursing
- Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
- Participation in another clinical study
- Allergies to imiquimod or any of the excipients in the cream
- Treatment within the past 90 days with any of the following:
- Psoralens plus ultraviolet A therapy
- Ultraviolet B therapy
- Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
- Chemotherapeutic or cytotoxic agents;
- Investigational agent
- Treatment within the past 30 days with any of the following:
- Surgical excision
- Photodynamic therapy
- Curettage
- Topical corticosteroids
- Laser
- Dermabrasion
- Chemical peel
- Imiquimod 5% cream
- Topical retinoids
- 5-fluorouracil
- Masoprocol
- Pimecrolimus or tacrolimus
Data sourced from ClinicalTrials.gov (NCT00774787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.