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5% KOH solution vs placebo treatment of actinic keratosis with different treatment duration
EU CTIS ID: 2024-514277-21-00
What this study is testing
The primary objective of the study is to demonstrate the superiority of the clinical efficacy of solcera (5% potassium hydroxide solution) for mild to moderate actinic keratosis compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years and < 90 years
- (At least one) palpable and/or clinically/dermatoscopically apparent actinic keratosis (lesion) severity grade I (mild) or II (moderate) according to Olsen
- Lesion(s) that is/are either easily accessible/treatable by the patient or - in the case of at least one lesion that is difficult to reach - availability of an assistant to be trained by the investigator before the first application of the investigational product, who will take over the treatment for the duration according to the protocol
- Written informed consent of the patient
You likely can't join if
- Number of lesions ≥ 6
- Other disruptive skin disease in the area intended for treatment
- Pharmacological or physical local therapy of actinic keratosis (or application of the active substances used for pharmacological therapy) in the area intended for treatment during the last 4 weeks
- Primary or secondary immunodeficiency
- Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
- Treatment with oral isotretinoin in the last 6 months
See the full eligibility criteria
- Age ≥ 18 years and < 90 years
- (At least one) palpable and/or clinically/dermatoscopically apparent actinic keratosis (lesion) severity grade I (mild) or II (moderate) according to Olsen
- Lesion(s) that is/are either easily accessible/treatable by the patient or - in the case of at least one lesion that is difficult to reach - availability of an assistant to be trained by the investigator before the first application of the investigational product, who will take over the treatment for the duration according to the protocol
- Written informed consent of the patient
- Number of lesions ≥ 6
- Other disruptive skin disease in the area intended for treatment
- Pharmacological or physical local therapy of actinic keratosis (or application of the active substances used for pharmacological therapy) in the area intended for treatment during the last 4 weeks
- Primary or secondary immunodeficiency
- Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
- Treatment with oral isotretinoin in the last 6 months
- Known tendency to excessive scarring
- Known intolerance/hypersensitivity to any of the components of the investigational medicinal products, in particular parabens
- Known serious mental illness or risk of suicide
- Other serious illnesses which, in the opinion of the investigator, prevent participation
- Obvious unreliability, unwillingness to cooperate or expected withdrawal of consent
- Size of the total lesion area > 25 cm2
- Known alcohol, medication or drug addiction
- Limited legal capacity
- Court/official order for placement in an institution
- Dependence on the sponsor or an investigator
- Participation in a clinical trial in the last 30 days
- Previous participation in this clinical trial
- Participation of a relative (in the same household) of the patient in this clinical trial
- Lesion diameter > 20 mm (largest diameter)
- Actinic keratosis (lesion) severity grade III (severe) according to Olsen
- Lesion in the immediate vicinity of the eyes, nostrils or mouth or mucous membranes, respectively
- Need for extensive treatment of a cancerized area
- Presence of a recurrent, persistent, indurated, thickened, painful, bleeding, ulcerating and/or rapidly growing lesion
- Existing skin cancer (all forms of skin cancer incl. basal cell carcinoma and squamous cell carcinoma) in the area intended for treatment
- Skin injuries, infected skin areas or dermatitis exfoliativa in the area intended for treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.