Actinic Keratosis
Conditions
Keywords
Actinic Keratosis AKs Chest Pre-Cancer
Brief summary
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%
Detailed description
This will be an open-label study to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% used in topical therapy of actinic keratosis on the chest. Subjects that present with 4 or more actinic keratosis in one continuous 100cm2 area of the chest and meet all inclusion/exclusion criteria will be enrolled into this study. Treatment with the investigational product (IP) will be applied for three continuous days. The investigator will guide application of the IP in-office at Day 0 and the subject will be instructed to self-administer the IP at Days 1 and 2. Follow-up visits will be scheduled at Days 1, 3, 10, 17, 24 and 59. Prior to treatment and at each visit, the investigator will assess the subject's treatment area for lesion counts and at follow up visits 4, 5, 6 and 7 evaluation of clearance. Pre-treatment photography will also be collected at baseline and at each follow up visit.
Interventions
DRUGInggenol Mebutate 0.015%
Sponsors
LEO Pharma
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female of at least 18 years of age. 2. Subjects willing to comply with study requirements. 3. The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2. 4. For female subjects of childbearing potential willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study. A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus, without both ovaries or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide) and abstinence. 5. Subjects willing to refrain from the use of topical products containing alpha-hydroxy acids, retinoic acid, retinol, salicylic acid, and vitamins C/D (or their derivatives) in the treatment area 7 Days prior to and during the entire study period
Exclusion criteria
1. Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel. 2. Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments. 3. Presence of any skin condition or disease that might interfere with the diagnosis and evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis). 4. Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study. 5. Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study. 6. Within 3 months of study entry treatments that may interfere with evaluation of the treatment area (e.g. other topical therapies for actinic keratosis of the chest, topical corticosteroids, topical retinoids, ultraviolet B phototherapy, or immunosuppressive, immunomodulating, or cytotoxic medications) or expected use of any of the above-mentioned therapies in the treatment area listed during the duration of the study. 7. Within 3 months of study entry topical treatment in the treatment area for actinic keratosis including, but not limited to imiquimond, 5- fluorouracil, diclofenac or liquid nitrogen. 8. Within 6 months of study entry treatments with Poly-L-lactic acid (PLLA; Sculptra Aesthetic) that may interfere with the evaluation of the treatment area. 9. Within 7 days of study entry use of self-tanners, excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of any listed during the time of the study within the treatment area. 10. Any systemic disease that is not yet stabilized for at least six (6) Months prior to entering study. 11. A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study 12. Pregnant or nursing women or women planning a pregnancy during the study period. 13. Any unhealed skin lesions or wounds within the treatment area. 14. Existence of one (1) or more suspected basal cell carcinoma or squamous cell carcinoma within the treatment area. 15. Current participation or participation within 30 days prior to the start of this study in a drug or investigational device research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lesion Count From Baseline to Day 59 | Day 59 | The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Inggenol Mebutate 0.015% | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Active | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Age, Continuous | 59.0 years STANDARD_DEVIATION 7.2 | — |
| Lesion Count | 11.3 Lesions STANDARD_DEVIATION 5.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 6 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Change in Lesion Count From Baseline to Day 59
The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.
Time frame: Day 59
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change in Lesion Count From Baseline to Day 59 | 2.7 Leasion Count | Standard Deviation 0.6 |