Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis (sun spots) on Balding Scalp including 12-month follow-up
- Conditions
- Actinic KeratosisMedDRA version: 19.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002451-10-GB
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 313
1. Signed and dated informed consent has been obtained.
2. Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 in2).
3. For subjects with a treatment area greater than or equal to 50 cm2 (8 in2) a tracking area of 50 cm2 (8 in2), with a minimum of 3 clinically typical, visible and discrete AKs, will be identified. The tracking area must be within the treatment area. If the treatment area is less than 50 cm2, the tracking area will be reduced and will be the same as the treatment
area.
4. Subjects at least 18 years of age.
5. Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
Female subjects are considered of childbearing potential unless they have been hysterectomised or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit.
6. Female subjects of child-bearing potential must be willing to use effective contraception
at trial entry and until Visit 7.
Effective contraception is defined as follows:
? Abstinence (when this is in line with the preferred and usual life style of the subject).
? Vasectomised partner (given that the subject is monogamous).
? An intrauterine device.
? Double barrier method defined as two distinct methods (two actual barrier methods).
? Hormonal contraceptive (oral hormonal birth control, oestrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment
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 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153
1. Location of the treatment area (full balding scalp)
? within 5 cm of an incompletely healed wound
? within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme (presently LP0084-68, LP0084-1013, LP0084-1014, LP0084-1015, LP0084-1148, LP0084-1077, LP0084-1193, LP0084-1194, LP0084-1196).
3. Treatment with ingenol mebutate gel in the treatment area within the last 12 months.
4. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 30 days.
5. Lesions in the treatment area that have: atypical clinical appearance (e.g. hypertrophic, hyperkeratotic or cutaneous horns) and/or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions).
6. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum).
7. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area.
8. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgement.
9. Any abnormal laboratory tests that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
10. Subjects known to be infected with Human Immunodeficiency Virus (HIV).
11. Subjects with any hematological malignancies.
12. Male subjects with QTcF interval > 450 ms and female subjects with QTcF interval > 470 ms). Other abnormal ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator. The QTcF intervals are not relevant for subjects with cardiac pacemaker.
13. Known sensitivity or allergy to any of the component(s) of the IP.
14. Presence of acute sunburn within the treatment area.
15. Current participation in any other interventional clinical trial.
16. Female subjects who are breastfeeding.
17. Subjects who in the opinion of the investigator, are unlikely to comply with the clinicaltrial protocol (e.g. due to alcoholism, drug dependency or psychotic state).
18. Close affiliation with the investigator (e.g. a close relative) or persons working at the trialsites or subject is an employee of the sponsor.
Prohibited Therapies and/or Medications within 2 weeks prior to Visit 2/Day 1:
19. Cosmetic or therapeutic procedures (e.g. use of liquid nitrogen, surgical excision,curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 cm of the treatment area.
20. Use of topical keratolytic therapeutic products (e.g. alpha- and beta- hydroxy a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the efficacy of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment;<br> Secondary Objective: To evaluate the safety of LEO 43204 gel (0.037% for scalp) in AK when applied topically once daily for three consecutive days as field treatment<br> <br> To evaluate the long term efficacy of LEO 43204 gel (0.037% for scalp) in AK in an extended 12-month follow-up period after initial complete clearance at Week 8<br> ;Primary end point(s): Complete clearance at Week 8, defined as no clinically visible AKs in the treatment area;Timepoint(s) of evaluation of this end point: Week 8
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): -Partial clearance at Week 8, defined as at least 75% reduction in the number of clinically<br> visible AKs in the treatment area<br> -Partial clearance at Week 4, defined as at least 75% reduction in the number of clinically<br> visible AKs in the treatment area<br> -Percent reduction in AK count in the treatment area at Week 8 compared to baseline<br> ;<br> Timepoint(s) of evaluation of this end point: -Week 8<br> -Week 4<br> -Week 8<br>