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LIVE BLOG: Treating Actinic Keratoses with Zyclara [Product Theater: Valeant]

In this interesting live blog from the SDPA Summer Conference, we address ZYCLARA Cream as a topical treatment for actinic keratosis (AK).  This product theater is supported by Valeant.


One of the biggest issues with AKs is that as soon as you see one, you often can’t go back, because others will likely be found.  This is different than treating the disease, with AKs, we must invest in treating the process.  If you see one, there are probably 10 more adjacent.  Left untreated, sun-damaged skin inevitably will progress.  


An important note: Our AK patients are becoming younger because of increase in tanning over the years.


Epidemiology of AK

1. AK affects more than 58 million Americans

2. AKs usually appear after age 40

3. The two major risk factors are: 

Individual susceptibility & Cumulative UV exposure


There is an iceberg effect of potential increase if we don’t treat these AKs effectively.


Clinical Features of AKs

1. Small, scaly lesions

2. Common on face & scalp

3. Abnormal keratinocytes in lower epidermis


+ AK lesions result from UV-induced damage over the extended area of the field.

+ Multiple AK lesions may be found next to each other.

+ Approach to field therapy = address both the visible and not-yet-seen lesions


ZYCLARA Cream (imiquimod)


Pump overview:

1. Controlled dosage

2. Ease of use

3. Be sure patients are only using one pump per day and maximize how much surface area they are using.


+ The mechanism of action of ZYCLARA in treating AK lesions is unknown, as are the pharmadoynamics.

+ Imiquimod is a Toll-like receptor 7 agonist that activates immune cells.  Topical application to skin is + associated with increases in markers for cytokines and immune cells.


Phase III Studies for ZYCLARA, 2.5% and 3.75%


Study Design:

In 2 double-blind, randomized, vehicle-conrolled studies, 479 subjects were treated with ZYCLARA cream 2.5%, ZYCLARA 3.5%, or vehicle once daily for two 2 -week treatment cycles separated by a 2-week non-treatment period and then followed for 8 weeks to the end of the study.


Primary endpoint was complete clearance (required absence of all lesions, including those that appeared during therapy of the treatment area).


Secondary endpoint was a partial clearance rate: those subject whom AKs were reduced by more than 75% compared to baseline.


Key Inclusion Criteria:

a. Age: 18 years or older

b. Treatment Area: full face or balding scalp (excluding ears)

c. 5-20 typical visible or palpable AKs


In the Clinical Results, the lesion count had significantly been reduced by Week 14.


Adverse Events

Flu-like symptoms might accompany or even precede local skin reactions and may include:

fatigure, nausea, fever, myalgias, arthralgias, malaise, and chills.  It’s also  important to also take note of the Serious Adverse Event (SAE) of this drug.  


[image by aubergene]

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