Actinic Keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: AVX001
Product Code: AVX001
Pharmaceutical Form: Gel
Other descriptive name: AVX001
Concentration unit: % (W/W) percent weight/weight
Concentration type: range
Concentration number: 1-3
Sponsors
Coegin Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants must be= 18 years of age 2. Fluent in Danish 3. Actinic Keratosis (AK) diagnosed by Central assessors (based on uploaded photo) 4. Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest 5. AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK 6. Able to and willing to follow trial procedures including application of AVX001 and using the Study App. 7. Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.0 or higher; iPhone with iOS 12.4 or higher 8. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or must be using a highly effective method of contraception. Contraception must be maintained for the duration of the study. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. AK lesions classified as Olsen grade 3 in target area 2. Atypical AK lesions in the target area, including suspected SCC or BCC 3. Under suspicion of ,or current skin cancer diagnosis in the target area. subjects who had BCC, SCC or melanoma and have completed curative therapy at least 12 months prior to screening and are in remission can be considered to participate in the trial by investigator’s discretion 4. Any dermatological condition in the target area that can be exacerbated by treatment or affect trial assessments, including but not limited to psoriasis vulgaris AD, rosacea, urticaria, scabies, and herpes simplex 5. Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit. 6. Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, metilprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit. 7. Received lesion or field directed therapy within 2 cm of the target area for trial treatment one month prior to baseline visit, including topical drugs, including but not limited to topical fluorouracil, imiquimod, ingenol mebutate and diclofenac. destructive therapies, including but not limited to surgery, cryotherapy, dermabrasion, and photodynamic therapy field ablation treatments, including but not limited to chemical peels, laser resurfacing 8. Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart 9. Any unstable neurological or psychiatric disorder based on the investigator's opinion which has the potential to affect the safety of the subject, influence on trial objectives or impede the subject’s ability to complete the trial. 10. History of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance at the investigator’s discretion 11. Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit. 12. Known allergy or intolerance to fish, shellfish or fish oil 13. Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrollment. 14. Subject is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks of field-directed treatment of subjects with AK. ;Secondary Objective: To evaluate safety of the daily application of AVX001 gel in doses of 1% or 3% for 4 weeks of field-directed treatment of subjects with AK. To evaluate the efficacy of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks in field-directed treatment of subjects with AK. To establish the dose-response efficacy relationship of daily applications of AVX001 gel in doses of 1% and 3% and vehicle for 4 weeks in field-directed treatment of subjects with AK. To evaluate the treatment satisfaction of daily applications of AVX001 gel in doses of 1% or 3% compared with vehicle for 4 weeks in field-directed treatment of subjects with AK. To evaluate the cosmetic outcome of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle for 4 weeks in field-directed treatment of subjects with AK. ;Primary end point(s): Proportion of subjects manifesting with LSR>2 at any time between Baseline and EOS.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of systemic safety based on reported SAE, AE, vital signs, skin examination. Proportion of subjects who experience LSR grade 1, 2, 3 and 4 from Baseline to EOT, and EOS Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic from baseline to the end of treatment visit (EOT) / early termination. Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic from baseline to the end of the study visit (EOS). Recurrence rate of AKs as assessed in-clinic after treatment clearance between EOT and EOS visits. Appearance of new lesions in the target area as assessed in-clinic from Baseline to EOS. Subject satisfaction with the AVX001 gel, assessed by TSQM at Week 2 and EOT. Proportion of patients with a cosmetic outcome grade <2 from Baseline to EOS, as assessed using the Cosmetic ScoringTool. ;Timepoint(s) of evaluation of this end point: If it states EOS the timepoint is 12 weeks If it states EOT the timepoint is 4 weeks | — |
Countries
Denmark
Contacts
Public ContactStudies&Me
Studies&Me
Outcome results
None listed