Clinical Trials for Actinic Keratosis: Treatment Options and Research Updates
Actinic keratosis is a common skin condition characterized by rough, scaly patches caused by sun exposure. Currently, there are 9 ongoing clinical trials testing various treatments including topical ointments, gels, creams, and combination therapies. These studies are being conducted across multiple European countries and aim to evaluate new treatment options for patients with this condition on the face, scalp, and other sun-exposed areas.
Clinical trial locations
- France
- Germany
- Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp
- Study on the Effectiveness of 5% Potassium Hydroxide Solution for Treating Mild to Moderate Actinic Keratosis in Adults
- Study on the Effectiveness of Green Tea Leaf Extract Ointment for Adults with Actinic Keratosis on the Scalp and Face
- Study on the Safety of Tirbanibulin and Diclofenac Sodium for Adults with Actinic Keratosis on the Face or Scalp
- Italy
- Netherlands
- Poland
- Spain
- Study on the Effectiveness and Safety of Cryotherapy and Tirbanibulin for Actinic Keratosis in Organ Transplant Patients
- Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp
- Study on the Safety and Effectiveness of Imiquimod Gel and Cream for Treating Actinic Keratosis in Adults
- Study on the Safety of Tirbanibulin and Diclofenac Sodium for Adults with Actinic Keratosis on the Face or Scalp
- Study on the Effectiveness and Safety of Metformin and Methyl Aminolevulinate in Daylight Therapy for Actinic Keratosis Patients
Study on the Effectiveness of 5% Potassium Hydroxide Solution for Treating Mild to Moderate Actinic Keratosis in Adults
This trial is testing a 5% potassium hydroxide solution called Solcera for treating mild to moderate cases of the condition. The treatment is compared against a placebo to determine its effectiveness.
Who can participate: Adults between 18 and 89 years old with at least one area of mild or moderate skin lesions are eligible. The affected area should be easy to reach and treat, or you should have someone available to help with applying the treatment. Written consent is required.
Who cannot participate: Patients with other skin conditions that might interfere with the study, those who have used any treatment in the past 30 days, those with known allergies to the medication, pregnant or breastfeeding women, patients with a history of skin cancer, and those unable to follow study procedures are excluded.
What the trial involves: The study involves applying Solcera solution directly to the affected skin areas. Treatment may occur in up to three cycles, depending on how the lesions respond. Complete clearance of lesions is assessed through control visits after each treatment phase. A follow-up visit monitors any relapses and long-term success.
Treatment being tested: Solcera is a topical keratolytic agent that works by breaking down abnormal skin cells, promoting their shedding and allowing healthier skin to form.
Study on the Effectiveness of Green Tea Leaf Extract Ointment for Adults with Actinic Keratosis on the Scalp and Face
This study is evaluating Veregen 10% Ointment, which contains an extract from green tea leaves, for treating lesions on the scalp and face. The ointment is being compared to a placebo to assess its effectiveness.
Who can participate: Adults aged 18 or older with clinically confirmed mild to moderate lesions on the face or bald scalp are eligible. Participants must have between 4 and 8 separate lesions in a treatment area of 25 square centimeters. The lesions must be classified as Olsen grade I or II. Participants need to be willing and able to follow study instructions and provide written consent.
Who cannot participate: Patients without lesions on the scalp or face, those outside the specified age range, patients unable to follow procedures, those with interfering medical conditions, pregnant or breastfeeding women, patients participating in other trials, those who have used certain recent treatments, and patients with allergies to the study medication are excluded.
What the trial involves: Participants apply the ointment to affected areas for 12 weeks, followed by a 4-week observation period and a 1-year follow-up to monitor long-term effects. Regular check-ups assess skin changes and safety throughout the study.
Treatment being tested: Veregen contains sinecatechins, a green tea leaf extract with antioxidant properties that help reduce abnormal skin cell growth.
Study on the Safety and Effectiveness of Imiquimod Gel and Cream for Treating Actinic Keratosis in Adults
This trial compares two treatments containing imiquimod: Keramod gel and Aldara cream, both designed to help the immune system fight abnormal skin growths.
Who can participate: Men and women over 18 with 4 to 8 non-thickened, non-raised lesions within a 25 square centimeter area on the face or balding scalp are eligible. Women of childbearing potential must use effective birth control and have negative pregnancy tests. Participants must be willing to avoid significant sun exposure and sign informed consent.
Who cannot participate: Patients with known allergies to study medications, those currently using other treatments, patients with a history of skin cancer or significant skin conditions, pregnant or breastfeeding women, those participating in another trial within 30 days, and patients with medical conditions the doctors believe would make participation unsafe are excluded.
What the trial involves: Participants apply either Keramod gel or Aldara cream to affected skin areas over 24 weeks. Two 8-week treatment cycles may be administered with evaluations after each cycle. The study monitors clearance of lesions, tolerance, satisfaction, and adherence to treatment.
Treatments being tested: Both Keramod and Aldara contain imiquimod, which stimulates the immune system to attack abnormal skin cells. Keramod is applied as a gel, while Aldara is applied as a cream.
Study on Cryotherapy and Tirbanibulin for Treating Actinic Keratosis on the Scalp and Forehead in Patients Aged 18 and Older
This trial evaluates a combination treatment approach using cryotherapy followed by Klisyri ointment containing tirbanibulin for lesions on the scalp and forehead.
Who can participate: Patients aged 18 or older with at least 8 visible or touchable lesions on the scalp and forehead are eligible. Lesions must be distributed in two non-overlapping zones of similar severity. Participants must be in good general health and able to understand and follow study procedures. Social insurance is required.
Who cannot participate: Patients younger than 18 or without lesions on the scalp and forehead are excluded.
What the trial involves: Treatment begins with cryotherapy, which uses extreme cold to destroy abnormal tissue. This is followed by application of tirbanibulin ointment to the treated areas. At 4 months, if lesions persist, another cryotherapy session may be administered. Complete response is assessed at 8 months, with a final evaluation at 12 months. Local skin reactions and pain are monitored throughout.
Treatments being tested: Cryotherapy freezes abnormal cells, while tirbanibulin ointment stops the growth of abnormal cells by inhibiting tubulin polymerization, which disrupts cell division.
Study on the Effectiveness and Safety of Metformin and Methyl Aminolevulinate in Daylight Therapy for Actinic Keratosis Patients
This study evaluates topical metformin combined with daylight photodynamic therapy using methyl aminolevulinate hydrochloride for treating lesions caused by sun exposure.
Who can participate: Males and females over 18 with at least 5 lesions on the face or scalp are eligible. Women of childbearing potential must use effective contraception throughout the study.
Who cannot participate: Patients outside the specified age range, those with medical conditions other than the targeted condition, patients in vulnerable populations, and those not meeting specific health criteria are excluded.
What the trial involves: The treatment phase lasts 12 weeks, during which topical metformin and methyl aminolevulinate are applied to the skin as part of daylight photodynamic therapy. This is followed by a 36-week observation period to monitor effectiveness and side effects.
Treatments being tested: Topical metformin is being evaluated for its potential to enhance treatment effects by affecting cellular energy processes. Methyl aminolevulinate is activated by daylight to treat lesions through photodynamic therapy.
Study on 5-Fluorouracil and Calcipotriol for Treating Actinic Keratosis in Patients
This trial compares a combination treatment of 5-Fluorouracil and Calcipotriol with 5-Fluorouracil alone over four weeks.
Who can participate: Adults over 18 with a diagnosis of the condition by a dermatologist are eligible. The diagnosis should be in areas such as the face, ears, balding scalp, neck, chest area, or upper arms. Participants must have at least 4 lesions in a treatment area no larger than 100 square centimeters, classified as Olsen grade I-III.
Who cannot participate: Patients outside the age range, those in vulnerable populations, patients without the condition, those unable to follow the treatment plan, patients with interfering medical conditions, those participating in another trial, patients with allergies to study medications, pregnant or breastfeeding women, and those with recent treatments or surgeries are excluded.
What the trial involves: Treatment is applied topically for four or six days for the combination group, or four weeks for the 5-Fluorouracil alone group. Evaluations occur at 3 and 12 months post-treatment to assess reduction in lesions, complete clearance, recurrence rates, and adverse effects. Quality of life is measured using questionnaires, and treatment adherence is monitored.
Treatments being tested: 5-Fluorouracil is an antimetabolite cream that interferes with DNA synthesis in abnormal cells. Calcipotriol is a vitamin D analog that helps regulate skin cell growth and enhances the effect of 5-Fluorouracil when used in combination.
Study on the Effectiveness and Safety of Cryotherapy and Tirbanibulin for Actinic Keratosis in Organ Transplant Patients
This study focuses on patients who have received a solid organ transplant, testing a combination of cryotherapy and tirbanibulin ointment.
Who can participate: Solid organ transplant recipients aged 18 or older with the condition are eligible. At least one year must have passed since transplant, and immunosuppressive treatment should be stable for at least 6 months. Participants must have 4 to 8 lesions in two symmetrical areas of 25 square centimeters on the face or scalp. Women of childbearing potential must use reliable contraception during and for one month after the study.
Who cannot participate: Patients without the condition, those who are not transplant recipients, patients under 18 or over 65, and those in vulnerable populations are excluded.
What the trial involves: Two symmetrical skin areas are treated: one with both cryotherapy and tirbanibulin, the other with cryotherapy alone. Cryotherapy is applied first, followed by application of Klisyri ointment once daily for five consecutive days. The study monitors changes in lesion numbers over three months, skin reactions, quality of life, and treatment satisfaction.
Treatments being tested: Cryotherapy uses extreme cold to freeze abnormal cells. Tirbanibulin is a microtubule inhibitor applied topically that stops abnormal cell growth, particularly useful for immunosuppressed patients.
Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp
This trial evaluates Tirbanibulin 10 mg/g ointment for treating lesions on the face or scalp, comparing it to a placebo.
Who can participate: Adults aged 18 or older with lesions on the face or balding scalp are eligible. A treatment field measuring more than 25 square centimeters and up to 100 square centimeters must contain 4 to 12 visible and separate lesions. Participants must avoid excessive sunlight or UV exposure during the study. Women of childbearing potential must use effective birth control and have negative pregnancy tests. Sexually active males with female partners must use two forms of birth control. Written consent is required.
Who cannot participate: Patients without lesions on the face or scalp, those under 18, patients unable to follow procedures or attend visits, those who used certain recent treatments, patients with interfering skin conditions, pregnant or breastfeeding women, recent participants in other trials, and patients with allergies to study ointment ingredients are excluded.
What the trial involves: Participants apply either tirbanibulin ointment or placebo once daily for five consecutive days to a treatment field. The primary assessment occurs on Day 57 to measure changes in lesion count. Secondary assessments evaluate partial clearance (75%) and complete clearance (100%) of lesions by Days 57 and 113. Some participants may receive a second treatment course.
Treatment being tested: Tirbanibulin is a microtubule inhibitor that disrupts cell division, leading to the death of abnormal skin cells when applied topically to larger skin areas.
Study on the Safety of Tirbanibulin and Diclofenac Sodium for Adults with Actinic Keratosis on the Face or Scalp
This long-term safety study compares tirbanibulin ointment with diclofenac sodium gel, focusing on preventing the development of squamous cell carcinoma over three years.
Who can participate: Men and women aged 18 or older with a 25 square centimeter treatment field on the face or scalp containing 2 to 8 visible lesions are eligible. The lesions must be Olsen grade 1. Women of childbearing potential must have negative pregnancy tests and use effective birth control. Participants must avoid sunlight and UV exposure to the face or scalp during the study. Written informed consent is required.
Who cannot participate: Patients with a history of skin cancer other than the targeted condition, those currently using other treatments, patients with allergies to study medications, pregnant or breastfeeding women, those who participated in another trial within 30 days, and patients with medical conditions making participation unsafe are excluded.
What the trial involves: Participants are randomly assigned to use either tirbanibulin ointment for five days or diclofenac gel for up to 90 days. The study lasts three years with regular monitoring and safety assessments, including vital signs and physical examinations. The main goal is to determine the occurrence of squamous cell carcinoma and evaluate long-term safety.
Treatments being tested: Tirbanibulin is a microtubule inhibitor applied as an ointment that prevents abnormal cell proliferation. Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID) applied as a gel that reduces inflammation and inhibits enzymes contributing to abnormal cell growth.
Summary
The nine ongoing clinical trials for treating this sun-related skin condition reflect a diverse research landscape across Europe. Spain and Germany are leading with multiple trials each, while France, Italy, the Netherlands, and Poland also host significant research. This geographic distribution ensures broad participation opportunities for patients across the continent.
Several treatment approaches are being investigated. Tirbanibulin ointment appears in multiple studies, both as a standalone treatment and in combination with cryotherapy, indicating strong research interest in this microtubule inhibitor. Traditional treatments like imiquimod and 5-Fluorouracil are also being evaluated, sometimes in combination with newer agents like calcipotriol. Natural product-based treatments, such as green tea extract, and innovative approaches like potassium hydroxide solution add to the variety of options under investigation.
Notably, one trial specifically focuses on organ transplant recipients, recognizing the unique needs of immunosuppressed patients. Several studies include long-term follow-up periods, with one spanning three years to assess safety and cancer prevention outcomes. Most trials focus on facial and scalp lesions, which are the most common and concerning locations for this condition.
These trials offer hope for patients seeking more effective, better-tolerated, or more convenient treatment options for managing rough, scaly patches caused by sun exposure.
