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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hyglegay Dw Lx Sdnpo Cqlf I Sphc Pat	Barcelona	Spain
Hfrvaxfh Vndb dtenoaup	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	20.01.2020

Trial locations

Investigated drugs:

Imiquimod

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.

Investigated diseases:

Actinic keratosis

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 ID:

2024-515667-60-00

Protocol code:

OJ-KDC01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?