2024-514277-21-00RecruitingPhase 3
Prospective, multistage, two-arm, randomised, double-blind study on the efficacy and safety of treatment of mild to moderate actinic keratosis with a 5% potassium hydroxide solution versus placebo with different duration of treatment cycles
INFECTOPHARM Arzneimittel und Consilium GmbH7 sites in 1 country630 target enrollmentStarted: January 30, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 630
- Locations
- 7
- Primary Endpoint
- Treatment success of the trial participants (“complete clearance” = complete, dermatoscopically confirmed remission of all actinic keratosis lesions of a trial participant that were present at the start of treatment and treated (with the investigational medicinal product)) at the control visit after the end of treatment (“EOT”, after the end of the off-phase of the 1st, 2nd or 3rd treatment cycle depending on the course of remission), evaluated separately for phase 1, 2 and 3.
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Treatment success of the trial participants (“complete clearance” = complete, dermatoscopically confirmed remission of all actinic keratosis lesions of a trial participant that were present at the start of treatment and treated (with the investigational medicinal product)) at the control visit after the end of treatment (“EOT”, after the end of the off-phase of the 1st, 2nd or 3rd treatment cycle depending on the course of remission), evaluated separately for phase 1, 2 and 3.
Treatment success of the trial participants (“complete clearance” = complete, dermatoscopically confirmed remission of all actinic keratosis lesions of a trial participant that were present at the start of treatment and treated (with the investigational medicinal product)) at the control visit after the end of treatment (“EOT”, after the end of the off-phase of the 1st, 2nd or 3rd treatment cycle depending on the course of remission), evaluated separately for phase 1, 2 and 3.
Secondary Outcomes
- Lesion-related treatment success ("complete remission") of the actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)), for which a complete remission was documented (at least once) until the end of treatment ("EOT"), evaluated separately for phase 1, 2 and 3
- Lesion-related treatment success ("complete remission") of the actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)), for which a complete remission was documented (at least once) until the respective visit, at all visit (except at the end of treatment ("EOT")), evaluated separately for phase 1, 2 and 3
- Lesion-related treatment success of actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)) with complete remission taking into account relapses, at all visits, evaluated separately for phase 1, 2 and 3
- Treatment success ("complete clearance") of the trial participants in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and additionally separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions occurring in the treated area after the start of treatment), at all visits, evaluated separately for phase 1, 2 and 3
- Treatment success of the trial participants without consideration of relapses in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and additionally separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions occurring in the treated area after the start of treatment), at all visits, evaluated separately for phase 1, 2 and 3
- Trial participants with "partial clearance" (at least 75% of actinic keratosis lesions (present at start of treatment and treated (with the investigational medicinal product)) with complete remission), at all visits, evaluated separately for phase 1, 2 and 3
- Response to therapy: trial participants with at least one actinic keratosis lesion with complete remission, at all visits, evaluated separately for phase 1, 2 and 3
- Percentage reduction in the number of lesions per trial participant compared to baseline (in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product)), at all visits, evaluated separately for phase 1, 2 and 3
- Trial participants with relapse: trial participants with relapse occurred after "complete clearance" (at least one actinic keratosis lesion (present at the start of treatment and treated (with the investigational medicinal product)) with relapse assessment), in relation to all trial participants and additionally separately in relation to trial participants with (previous) "complete clearance", in the period up to the follow-up visit, evaluated separately for phase 1, 2 and 3
- Actinic keratosis lesions with relapse: actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)) with relapse assessment, in relation to all actinic keratosis lesions and additionally separately in relation to actinic keratosis lesions with (previous) complete remission, in the period up to the follow-up visit, evaluated separately for phase 1, 2 and 3
- Healing stage/condition of the actinic keratosis lesions over time at all visit, overall and according to localisation and size in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and also separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions that occurred in the treated area after the start of treatment), evaluated separately for phase 1, 2 and 3
- Efficacy, tolerability and overall assessment by the investigator and the trial participant in school grades (1-6, at the end of treatment ("EOT") and at the follow-up visit), evaluated separately for phase 1, 2 and 3
- Adverse events, serious adverse events, side effects and serious side effects (with separate presentation of local reactions, query "Part of the expected/desired inflammatory reaction?", duration and separately duration in relation to the duration of treatment as well as number and duration after the end of treatment with the investigational medicinal product), evaluated separately for phase 1, 2 and 3
- Dropouts (with reason for discontinuation and timepoint), evaluated separately for phase 1, 2 and 3
- Compliance, evaluated separately for phase 1, 2 and 3
Investigators
Tanja Wehran
Scientific
INFECTOPHARM Arzneimittel und Consilium GmbH
Study Sites (7)
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