Cycle therapy of actinic keratoses of the face and scalp with 5% topical imiquimod cream: An open-label trial

Background. Imiquimod 5% is licensed for the treatment of external genital warts, superficial basal cell carcinoma, and actinic keratosis (AK) and is being used experimentally in various other dermato-oncological conditions.Objective. This observational study shall show that nonmelanoma skin cancer can be detected at its earliest subclinical stage by its reaction with imiquimod and can be cleared by finishing the course of treatment.Material and Methods. In this single arm trial 15 patients with chronically sun-exposed skin who had no clinical evidence of AK were treated with 5% imiquimod cream on the face or scalp for 4 weeks three times per week.Results. During treatment, all patients developed multiple areas with mild to moderate inflammatory skin reactions, such as erythema, induration, and scaling. Biopsies obtained from 12 patients prior to treatment revealed no malignancies. However, in cases with more pronounced inflammation during treatment, targeted biopsies indicated very early malignant alterations.Conclusion. Topical imiquimod treatment of chronically sun-exposed skin without overt clinical signs of AK is able to detect subclinical actinic keratoses (SAK) and to completely clear the lesions, even before they can be clinically diagnosed as AK. In such patients, imiquimod might be able to prevent the evolution of SCC.

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Efficacy of Imiquimod as an Adjunct to Cryotherapy for Actinic Keratoses

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2007.00033 ◽

2007 ◽

Vol 11 (6) ◽

pp. 195-201 ◽

Cited By ~ 15

Author(s):

Jerry K.L. Tan ◽

D. Richard Thomas ◽

Yves Poulin ◽

Frances Maddin ◽

Jing Tang

Keyword(s):

Randomized Trial ◽

Statistical Significance ◽

Standard Of Care ◽

Progressive Increase ◽

Controlled Trials ◽

Progressive Reduction ◽

Open Label ◽

Actinic Keratoses ◽

Topical Imiquimod ◽

The Face

Background: Cryotherapy is the standard of care for clinically apparent (target) actinic keratoses (AKs). Topical imiquimod may reduce initially inapparent or subclinical AKs. Objective: We evaluated the potential of topical imiquimod to decrease subclinical AKs after cryotherapy of target AKs. Methods: A randomized trial of imiquimod or vehicle twice weekly for 8 weeks following 3- to 5-second cryotherapy of target AKs within a 50 cm2 field at the face or scalp was conducted. Efficacy outcomes included clearance of target, subclinical, and total AKs and proportions clear of AKs. Subjects with residual AKs were offered cryotherapy and open-label imiquimod twice weekly for 8 weeks. Results: Sixty-three subjects completed the randomized phase. At 12 weeks, target AK clearance was similar for imiquimod and vehicle (79% vs 76%), but fewer total AKs were noted for imiquimod (78 vs 116). This was due to a progressive reduction in subclinical AKs with imiquimod compared with a progressive increase with vehicle. More subjects treated with imiquimod achieved clearance of subclinical (58% vs 34%; p = .06) and total (23% vs 9%; p = .21) AKs. Conclusion: Imiquimod postcryotherapy may increase clearance of subclinical and total AKs and proportions of subjects clear at 3 months. These findings require confirmation in larger controlled trials powered for statistical significance.

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Do Second-Time Users of Topical Imiquimod have a More Rapid Onset of Clinical Response?

SKIN The Journal of Cutaneous Medicine ◽

10.25251/skin.2.3.1 ◽

2018 ◽

Vol 2 (3) ◽

pp. 156-161

Author(s):

Stacy L McMurray ◽

Matthew Reynolds ◽

Matthew S Dinehart ◽

Scott M Dinehart

Keyword(s):

Clinical Response ◽

Time Use ◽

Γδ T Cells ◽

Rapid Onset ◽

Primary Objective ◽

Imiquimod Cream ◽

Actinic Keratoses ◽

Topical Imiquimod ◽

Primary Endpoints ◽

Time To Onset

Introduction: Topical imiquimod is commonly used in dermatology for treatment of actinic keratoses (AK). Prior studies in humans and mice have suggested the potential for immune recall with imiquimod based on higher degrees of AK clearance and activation of memory γδ T-cells in a mouse model. Anecdotal reports suggest a more rapid time-to-onset of clinical response with second time use of imiquimod. However, the potential for immune recall demonstrated by time-to-onset of clinical response has not been formally investigated.Objective: The primary objective of this study was to determine if there is a difference in time-to-onset of clinical response between naïve and prior users of topical imiquimod for the treatment of actinic keratoses.Methods: A total of 92 patients were treated with 5% imiquimod cream for actinic keratoses of the head and neck. Patients were instructed to apply 5% imiquimod cream to the affected areas once daily until reaching a therapeutic endpoint of crusting/scabbing. The primary endpoints in the study were time (days) to onset of erythema and time to onset of crusting/scabbing. Results were self-reported.Results: The average time (days) to onset of erythema was 5.48 ± 3.19 days in naïve users and 4.7 ± 2.91 days in prior users (p= 0.22). Average time to onset of crusting/scabbing was 9.2 ± 4.34 days in naïve users and 9.02 ± 3.65 days in prior users (p=0.35).Conclusion: Our study revealed there is no difference in time-to-onset of erythema or scabbing/crusting with second-time use of imiquimod. While immune recall may be possible with use of imiquimod, the results of this study indicate that it may be independent of time-to-onset of clinical response.

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