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Study on the Safety and Effectiveness of Imiquimod Gel and Cream for Treating Actinic Keratosis in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of actinic keratosis, a skin condition that often appears as rough, scaly patches on sun-exposed areas of the skin. The study compares two treatments: Keramod® gel and Aldara® cream, both of which contain the active ingredient imiquimod. Imiquimod is a chemical substance used to help the immune system fight abnormal skin growths.

The purpose of the study is to evaluate the effectiveness and safety of these two treatments in achieving complete clearance of actinic keratosis lesions. Participants will apply either Keramod® gel or Aldara® cream to the affected skin areas. The study will monitor the progress over a period of 24 weeks, with assessments at various points to check the reduction or clearance of the lesions.

Throughout the study, participants will be asked to complete questionnaires to assess their tolerance and satisfaction with the treatment. The study will also track how well participants adhere to the treatment schedule and any side effects they may experience. The ultimate goal is to determine which treatment is more effective in clearing actinic keratosis lesions while being well-tolerated by patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study involves the use of two medications: Keramod® Gel and Aldara® Cream, both containing the active ingredient imiquimod at a concentration of 50 mg/g.

    The treatment is applied to the skin (cutaneous use) on areas affected by actinic keratosis, which are non-hyperkeratotic and non-hypertrophic lesions.

    The treatment area should be a 25 cm² contiguous area on either the face or balding scalp.

    The initial treatment cycle lasts for 8 weeks, during which the medication is applied as directed by the study protocol.

  2. Step 2

    First evaluation

    At the end of the first 8-week treatment cycle, an evaluation is conducted to assess the partial and complete clearance of actinic keratosis lesions.

    This evaluation is referred to as visit 3 in the study timeline.

  3. Step 3

    Second treatment phase

    If necessary, a second treatment cycle is initiated, lasting another 8 weeks.

    The same application method and dosage are followed as in the initial treatment phase.

  4. Step 4

    Second evaluation

    At the end of the second 8-week treatment cycle, another evaluation is conducted to assess the clearance of lesions.

    This evaluation is referred to as visit 5 in the study timeline.

  5. Step 5

    Final assessment

    The primary goal is to achieve complete clearance of actinic keratosis lesions by week 24 from the first treatment dose.

    The study also evaluates the tolerance and acceptability of the treatment through a questionnaire.

    Adherence to the treatment protocol is assessed using a Treatment Adherence Questionnaire.

Who can join the trial?

9 criteria

  • Patients must have 4 to 8 clinically diagnosed, non-thickened, non-raised actinic keratosis (AK) spots within a 25 cm2 area on either the face or balding scalp. Actinic keratosis is a rough, scaly patch on the skin caused by sun exposure.
  • Must be a man or woman aged over 18.
  • Women must either be 1 year past menopause, surgically unable to have children, or agree to use a medically accepted form of birth control.
  • The area where the treatment will be applied should be free of any significant findings, like tattoos.
  • Any skin type or race is allowed, as long as the skin color allows for clear observation.
  • Must be willing to follow the birth control requirements as defined in the study.
  • Must sign the informed consent form, which is a document explaining the study and confirming your agreement to participate.
  • Must be able to understand and meet the study requirements.
  • Must be in good health, as confirmed by medical history and physical examination, and free of any significant disease or condition, other than actinic keratosis, that could interfere with the study evaluations.

Who cannot join the trial?

6 criteria

  • Patients who have a known allergy or sensitivity to the study medications, which are Keramod® Gel or Aldara® Cream.
  • Patients who are currently using other treatments for actinic keratosis, which is a skin condition caused by sun damage.
  • Patients with a history of skin cancer or other significant skin conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding, as the effects of the study medications on unborn babies or infants are not known.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Keramod

    is a gel containing imiquimod, which is used to treat actinic keratosis, a skin condition caused by sun damage. The gel is applied to the affected areas of the skin to help clear the lesions. It works by stimulating the immune system to attack the abnormal skin cells.

  • Aldara

    is a cream that also contains imiquimod and is used for the same purpose as Keramod. It is applied to the skin to treat actinic keratosis by boosting the body's immune response to target and eliminate the damaged skin cells.

What is already known about the treatment

  • Keramod

    This medication is administered as a gel applied directly to the skin. It is currently being studied in clinical trials for its effectiveness in treating actinic keratosis, a skin condition caused by sun damage. Keramod works by stimulating the immune system to attack abnormal skin cells. It belongs to the class of immune response modifiers.

  • Aldara

    This medication is applied as a cream directly to the affected skin area. It is well-established in medical literature for treating actinic keratosis. Aldara functions by enhancing the body's immune response to target and eliminate abnormal cells. It is classified as an immune response modifier.

Investigated diseases

Actinic keratosis – Actinic keratosis is a skin condition characterized by rough, scaly patches on the skin, often resulting from prolonged exposure to the sun. These patches are typically found on areas such as the face, ears, lips, back of the hands, forearms, scalp, or neck. The condition progresses slowly and may develop over several years. It is more common in fair-skinned individuals and those who have spent a lot of time outdoors. The patches can vary in color, appearing pink, red, or brown, and may feel itchy or tender. If left untreated, actinic keratosis can potentially lead to more serious skin conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515667-60-00Protocol codeOJ-KDC01Estimated enrolment68 patientsSponsorLaboratorios Ojer Pharma S.L.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).