TUVATEXIB for Actinic keratosis

Inclusion criteria

• {"criterion_text":"- Written informed consent prior to any study-related measure.\n- Male, female, diverse patients aged 18 years or older.\n- Clinically confirmed diagnosis of AK of the face or scalp.\n- AKASI (Actinic Keratosis Area and Severity Index) of at least 3.0.\n- Minimum of one AK lesion with a PRO score ≥ 2 on scalp or face, as assessed by LC-OCT at Visit 1.\n- Among the AK lesions with the highest PRO, the investigator must be able to identify one AK lesion which is suitable to serve as marker lesion for the primary endpoint assessment.\n- The area around the defined marker lesion must contain 4 to 8 isolated AK lesions (counted including the marker lesion) and will be suitable to serve as study treatment area, i.e. no further exclusion criterion applies to this area.\n- Expected high patient compliance in applying the study medication and following the study instructions."}

Exclusion criteria

• {"criterion_text":"- Treatment area extends to either eyelids, lips, ears, or nose.\n- Patients not willing to stop the use of make-up, coloured day care cremes, and sunscreens in the treatment area within 12 hours prior to any study visit.\n- Patients not willing to abstain from sunbathing (including solarium) or any outdoor activities with intensive sun exposure without taking appropriate measures to protect the treatment areas during the study.\n- Pregnant or breast-feeding patients.\n- Women of childbearing potential not willing to use a highly effective method of contraception (failure rate of less than 1% per year) during the interventional period of the study and 2 weeks thereafter.\n- Non-vasectomized male study participants with female partners of childbearing potential not willing to use a highly effective method of contraception (failure rate of less than 1% per year) during the interventional period of the study and two weeks thereafter.\n- Patients having participated in another clinical study (medical devices, or medicinal products) during the 4 weeks before inclusion into this clinical study.\n- Any previous randomization into this clinical study.\n- Any suspicion of current drug or alcohol abuse.\n- Institutionalization because of legal or regulatory order.\n- Dependency (as an employee or relative) to the sponsor/responsible CRO or investigator and investigational team.\n- History of a genetic skin-cancer disorder (e.g., xeroderma pigmentosum) or invasive tumour in the treatment area (e.g., Merkel cell tumour, invasive SCC or suspected or diagnosed malignancy (recent or within the preceding 5 years) or BCC (basal cell carcinoma, within the preceding 2 years).\n- Suspected poor compliance.\n- AK with Olsen grade III in the treatment area.\n- Clinically significant scars, or hyperpigmentation, or tattoo in the treatment area.\n- History or evidence of skin conditions other than AK likely to interfere with the study evaluations, e.g., eczema or unstable psoriasis.\n- Need for immunosuppressive or immunomodulating treatments (including systemic or topical agents applied to the treatment area, such as corticosteroids or calcineurin inhibitors) or other therapies against malignancy and other AK treatments (such as Imiquimod, 5FU or PDT).\n- Evidence of clinically significant or unstable medical conditions such as metastatic tumour or tumour with high probability of metastatic spread, heart failure (NYHA class III or higher), immunosuppressive disorder (e.g., HIV, status post organ transplantation), hematologic, hepatic, renal, neurologic or endocrine disorder, collagen-vascular disorder (e.g., cerebrovascular or other bleeding disorders), gastrointestinal disorder (e.g., active ulcera or history of recurrent peptic ulcera or haemorrhage).\n- Known allergy to lidocaine (applies only to patients who consented to have a biopsy).\n- Patients not willing to stop the use of skin care products in the treatment area during the treatment and follow-up period (i.e. the whole study duration)."}

Primary endpoints

• {"endpoint_text":"- The modified PRO score of the marker lesion assessed by LC-OCT after a treatment period of 12 weeks will serve as primary endpoint. The marker lesion will be defined as the AK lesion with the highest PRO score (basal proliferation score as assessed by LC-OCT prior to treatment start) on head or face of the study participant at study entry","definition_or_measurement_approach":"Assessed by LC-OCT after a 12-week treatment period; marker lesion is defined as the AK lesion with the highest basal proliferation (PRO) score as assessed by LC-OCT prior to treatment start."}

Secondary endpoints

• {"endpoint_text":"- 1. Secondary efficacy endpoints: The clearance of budding (PRO II) and papillary sprouting (PRO III) of the marker lesion assessed by LC-OCT at week 12.","definition_or_measurement_approach":"Assessment by LC-OCT at week 12 for clearance of PRO II (budding) and PRO III (papillary sprouting)."}
• {"endpoint_text":"- Histological assessment of the modified PRO score of the marker lesion after a treatment period of 12 weeks based on a biopsy (optional).","definition_or_measurement_approach":"Optional biopsy with (immuno-)histological examination to assess modified PRO score after 12 weeks."}
• {"endpoint_text":"- Number of visible or palpable AK lesions in the treatment area.","definition_or_measurement_approach":"Count of visible or palpable actinic keratosis lesions in the predefined treatment area."}
• {"endpoint_text":"- Complete clearance rate assessed by lesion count with complete clearance being defined as the complete disappearance of all visible or palpable AK lesions in the treatment area.","definition_or_measurement_approach":"Lesion count comparison to baseline; complete clearance defined as disappearance of all visible or palpable lesions in the treatment area."}
• {"endpoint_text":"- Partial clearance rate 75%. A partial clearance 75% is achieved if the number of clinically visible or palpable AK lesions in the treatment area is reduced by at least 75% but less than 100% compared with baseline","definition_or_measurement_approach":"Lesion count reduction compared with baseline; ≥75% and <100% reduction defines partial clearance 75%."}
• {"endpoint_text":"- Assessment of cosmetic appearance after 12 weeks in comparison to Visit 1.","definition_or_measurement_approach":"Investigator (or specified scale) assessment comparing cosmetic appearance at 12 weeks to baseline (Visit 1)."}
• {"endpoint_text":"- Study participants’ assessment of the test product in comparison to placebo at the end of treatment.","definition_or_measurement_approach":"Participant-reported assessment comparing test product and placebo at end of treatment (method or instrument not specified)."}
• {"endpoint_text":"- 2. Secondary safety endpoints: (Serious) adverse events.","definition_or_measurement_approach":"Recording and reporting of adverse events and serious adverse events during the study period."}
• {"endpoint_text":"- Local Skin Reaction Scores.","definition_or_measurement_approach":"Assessment of local skin reactions using predefined scoring (specific scale not provided in the record)."}
• {"endpoint_text":"- Number of histologically confirmed squamous cell carcinoma (SCC) in the treatment area.","definition_or_measurement_approach":"Histological confirmation of SCC occurrences in the treatment area documented during the study."}

Germany

Earliest CTIS Part Ii Submission Date

18-08-2025

Latest Decision Or Authorization Date

03-11-2025

Processing Time Days

77

Number Of Sites

1

Number Of Participants

39

Primary sponsor

Full Name

Vidac Pharma Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Israel

Contract research organisations

Name

Forschungsdock CRO GmbH

Responsibilities

codes: 1,5

Third parties

• {"country":"Germany","full_name":"Forschungsdock CRO GmbH","duties_or_roles":"codes: 1,5","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Dr. Nibler & Partner mbB Aerzte","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Phortas GmbH","duties_or_roles":"codes: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Psy Consult Scientific Services","duties_or_roles":"codes: 10","organisation_type":"Industry"}
• {"country":"Germany","full_name":"Steinbeis Beratungszentren GmbH","duties_or_roles":"codes: 5","organisation_type":"Pharmaceutical company"}
• {"country":"Austria","full_name":"ABF Pharmaceutical Services GmbH","duties_or_roles":"codes: 15,5; value: IMP Packaging, Labelling, QP Release and Distributions","organisation_type":"Pharmaceutical company"}