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.
Conditions
Interventions
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/
Sponsors
LABORATORIO OJER PHARMA, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactPATRICIA OJER
LABORATORIO OJER PHARMA, S.L.
Outcome results
None listed