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Phase 2
18 Years
Not Enrolling
Actinic Keratosis

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Trial Information

Inclusion Criteria:

1. Written informed consent form (ICF) signed and dated by the patient prior to any
study-related activity

2. Male or female patients aged 18 or older

3. Have a total of 5-20 clinically confirmed, palpable or visible (grade I or II
according to modified Olsen score) nonhyperkeratotic, nonhypertrophic AK lesions
located within a contiguous 25 - 100 cm² area on the balding scalp or face

4. Any skin type or race, providing the skin pigmentation will allow discernment of

5. Willingness to actively participate in the study and to comply with the study
procedures as defined in the study protocol

6. High probability of a good compliance and orderly completion of the study

7. Negative urine pregnancy test (in female subjects with childbearing potential)


Exclusion Criteria:

1. Evidence of clinically significant, unstable cardiovascular or immunosuppressive,
hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or
gastrointestinal abnormalities or disease

2. Diagnosed autoimmune diseases and anaemia

3. Any dermatological disease and or condition in the treatment or surrounding area that
may be exacerbated by treatment with imiquimod or cause difficulty with examination
(e.g. rosacea, psoriasis, atopic dermatitis, eczema)

4. Any significant findings (e.g. tattoos) in the potential application site area that
may impair examination of treatment or surrounding area

5. Confirmed squamous cell or basal cell carcinoma anywhere on the head in the past 3

6. Share a household where there is a person participating in a concurrent clinical
study of imiquimod or being treated with imiquimod 5% topical cream

7. Active chemical dependency or alcoholism, as assessed by investigator

8. Patients unwilling to stay out of the sun or wear protective clothing or to take
appropriate measures to cover the treatment area during the study

9. Previous treatments with imiquimod for AK in the predetermined treatment area within
the past 3 months

10. Treatment with COX-2 inhibitors 14 days prior to randomization

11. Currently using or have used on the treatment area over-the-counter retinol products,
corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic
keratosis treatments 28 days prior to randomization

12. Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.

13. Known allergy or sensitivity to imiquimod or any of the excipients (butyl lactate,
isopropyl myristate, propylene glycol, butylated hydroxy anisole) in the IMP

14. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women

- are pregnant or nursing,

- are not surgically sterile,

- are of child bearing potential and not practicing an acceptable method of birth
control, or does not plan to continue practicing an acceptable method of birth
control throughout the trial (acceptable methods include intrauterine devices
(IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap
with intravaginal spermicide, condom with intravaginal spermicide or
vasectomised partner)

15. Participation in another clinical trial with an investigational drug or device during
the previous 4 weeks before Baseline

16. Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser
abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study

17. Currently using or have used systemic steroids 2 months prior to study except inhaled
corticosteroids (<1200 microgram/day for beclomethasone, or <600 microgram/day for

18. Known infectious diseases (e.g. HIV, hepatitis)

19. Psychiatric condition that might limit the participation in the study and/or that
lead to the assumption that the ability to completely understand the consequences of
consent is missing

20. The Patient is institutionalized by virtue of an order issued either by the judicial
or the administrative authorities

21. Employee of the study site or of the Sponsor's company

22. Any disease or circumstances on account of which the subject should not participate
in the study in the opinion of the investigator -

Type of Study:


Study Design:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic