Imiquimod for Actinic keratosis

Inclusion criteria

• {"criterion_text":"- 1.\tPatients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment área on either the face or balding scalp."}
• {"criterion_text":"- 2.\tMan or woman aged over 18."}
• {"criterion_text":"- 3.\tWomen either must be 1 year postmenopausal, surgically sterile, or agree to use a medically accepted form or birth control."}
• {"criterion_text":"- 4.\tFree of any significant findings (e.g. tattoos) in the potential application site area."}
• {"criterion_text":"- 5.\tAny skin type or race, providing the skin pigmentation will allow discernment."}
• {"criterion_text":"- 6.\tMust be willing to comply with the contraception requirements as defined in Section 6.2.4."}
• {"criterion_text":"- 7.\tSignature of the informed consent form."}
• {"criterion_text":"- 8.\tPatients with the ability to understand and fulfil the study requirements."}
• {"criterion_text":"- 9.\tIn good health, as confirmed by medical history and physical examination, and free of any clinically significant disease/condition, other than actinic keratosis, that could interfere with the study evaluations."}

Exclusion criteria

• {"criterion_text":"- 1.\tBasal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area."}
• {"criterion_text":"- 10.\tReceiving immunosuppressive medication."}
• {"criterion_text":"- 11.\tHistory of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, mental, neurological or any other disease in the last 2 years prior to enrollment that could hinder regular treatment and supervision of the patient and could cause premature withdrawal of the study."}
• {"criterion_text":"- 12.\tMentally incapacitated patients."}
• {"criterion_text":"- 13.\tCurrent history or history of drug or alcohol abuse in the last 3 years prior to enrollment."}
• {"criterion_text":"- 14.\tExposure to a product under investigation in the last 3 months prior to enrollment."}
• {"criterion_text":"- 15.\tKnown to be affected by porphyria."}
• {"criterion_text":"- 2.\tPresence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area."}
• {"criterion_text":"- 3.\tHistory of cutaneous hyperreactivity or irritation to topical products."}
• {"criterion_text":"- 4.\tEngaging in activities involving excessive or prolonged exposure to sunlight."}
• {"criterion_text":"- 5.\tReceiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry."}
• {"criterion_text":"- 6.\tCurrently using or have used systemic steroids 2 months prior to study."}
• {"criterion_text":"- 7.\tCurrently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization."}
• {"criterion_text":"- 8.\tFemales who are pregnant, breastfeeding or planning to become pregnant during the first administration of IMP until 6 months after the last dose of IMP."}
• {"criterion_text":"- 9.\tHistory of allergy or sensitivity to imiquimod or related compounds or other components of the formulation."}

Primary endpoints

• {"endpoint_text":"- Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.","definition_or_measurement_approach":"Defined as a count of zero AK lesions at week 24 since the first treatment dose."}

Secondary endpoints

• {"endpoint_text":"- 1.\tPartial and complete clearance rate of AK lesions at the end of first and second cycles: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).","definition_or_measurement_approach":"Assessment at Week 8 and Week 16; percentage of subjects with reduction (partial and complete clearance) compared to baseline as described (≥75% reduction referenced in translation)."}
• {"endpoint_text":"- 2.\tTolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire.","definition_or_measurement_approach":"Assessed by Treatment tolerance and satisfaction questionnaire completed by subjects."}
• {"endpoint_text":"- 3.\tEvaluation of adherence by Treatment Adherence Questionnaire.","definition_or_measurement_approach":"Assessed by Treatment Adherence Questionnaire."}
• {"endpoint_text":"- 4.\tRate of subjects who complete one treatment cycle.","definition_or_measurement_approach":"Proportion of subjects completing one treatment cycle (end of first cycle)."}
• {"endpoint_text":"- 5.\tRate of subjects who complete two treatment cycles.","definition_or_measurement_approach":"Proportion of subjects completing two treatment cycles (end of second cycle)."}
• {"endpoint_text":"- 6.\tSeverity and frequency of associated adverse events/serious adverse events (AEs/SAEs).","definition_or_measurement_approach":"Collection and analysis of AEs/SAEs for severity and frequency throughout study."}

Spain

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

23-06-2025

Processing Time Days

355

Number Of Sites

5

Number Of Participants

68

Primary sponsor

Full Name

Laboratorios Ojer Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Pivotal S.L.","duties_or_roles":"codes: 1,10,11,12,2,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Fundacio Privada Dau","duties_or_roles":"codes: 14","organisation_type":"Laboratory/Research/Testing facility"}