An exploratory, multicenter, randomized, open-label with blind evaluation, active-controlled study to evaluate the safety and efficacy of Keramod

INTERVENTION: Product Name: KERAMOD Product Code: NA Pharmaceutical Form: Gel INN or Proposed INN: IMIQUIMOD CAS Number: 99011‐02‐6 Current Sponsor code: IMIQUIMOD Other descriptive name: NA Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50‐ Trade Name: ALDARA Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011‐02‐6 Current Sponsor code: IMIQUIMOD Other descriptive name: NA Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50‐ CONDITION: ACTINIC QUERATOSIS, also known as solar keratosis, is a skin disease caused by chronic exposure to sunlight. It appears as scaly lesions on the skin as a result of an abnormal growth of the cells in the most outer layer of the epidermis. There may be a single lesion or multiple lesions, and they are usually found on areas of the skin that are regularly exposed to the sun, such as the face, neck, hands, forearms and scalp. Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: ; Secondary Objective: • To evaluate the reduction in the number of AK lesions from baseline to weeks 8 and 16 in subjects treated with Keramod® Gel versus Aldara® Cream.; • To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream).; • To evaluate the safety of the topical treatment of Keramod® Gel versus Aldara® Cream.; • To evaluate the treatment tolerance and patient acceptance of the treatment in subjects treated with Keramod® Gel versus Aldara® Cream.; • To evaluate quality of life in subjects treated with Keramod® Gelm versus Aldara® Cream.; Main Objective: To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose. Primary end point(s): Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose. Timepoint(s) of evaluation of this end point: Time Frame: 8 weeks post‐treatment (Week 24, Test of Cure/ TOC, visit 6) INCLUSION CRITERIA: Patients must have 4 to 8 clinically diagnosed, non‐hyperkeratotic, non‐hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54 SECONDARY OUTCOME: ; Secondary end point(s): • Partial clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with at least a 75% reduction in the number of AK lesions counted at baseline.; • Complete clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with a count of zero AK lesions; • Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire; • Quality of life assessed by the Actinic Keratosis Quality of Life Questionnaire; • Rate of subjects who complete one treatment cycle; • Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs); ; Timepoint(s) of evaluation of this end point: • Partial 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).; • Tolerance and acceptability: Visits 2, 3, 4, 5 & 6.; • Quality of life assessed: Week 24; Visit 6.; • Rate of subjects who complete one and two treatment cycles: Week 8; Visit 3 and Week 16; Visit 5.; • Severity and frequency of associated adverse events/serious adverse events: Week 24.;